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epirubicin

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Description

Epirubicin is an anthracycline antibiotic chemotherapy drug. It is a derivative of daunorubicin, and it is used to treat a variety of cancers, including breast cancer, lung cancer, and leukemia. Epirubicin is thought to work by interfering with the replication of DNA, which is essential for cell growth and division. Epirubicin is synthesized by a multi-step process involving several chemical reactions. It is administered intravenously, and it can cause a number of side effects, including nausea, vomiting, hair loss, and bone marrow suppression. Despite these side effects, epirubicin is a highly effective chemotherapy drug, and it has been shown to improve survival rates in patients with a variety of cancers. Epirubicin is studied extensively to understand its mechanisms of action, to develop new and improved treatment regimens, and to reduce its side effects.'

Epirubicin: An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID41867
CHEMBL ID417
CHEBI ID47898
SCHEMBL ID8582
MeSH IDM0023488

Synonyms (107)

Synonym
ellence
4'-epi-doxorubicin
farmorubicin
(1s,3s)-3,5,12-trihydroxy-3-(hydroxyacetyl)-10-(methyloxy)-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranoside
(7s,9r)-7-[(2s,4s,5r,6s)-4-amino-5-hydroxy-6-methyl-oxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7h-tetracene-5,12-dione
pidorubicina [inn-spanish]
wp 697
hsdb 6962
brn 1445813
5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8s-cis)-
epirubicin [inn:ban]
pidorubicine [inn-french]
imi 28
epirubicinum [inn-latin]
epi-dx
epirubicina [spanish]
nsc 256942
epirubicine [french]
epirubicina [inn-spanish]
epirubicinum [latin]
epirubicine [inn-french]
4'-epi-dxr
5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-beta-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8s-cis)-
4-epidoxorubicin
pidorubicinum [inn-latin]
ccris 2261
ridorubicin
10-((3-amino-2,3,6-trideoxy-beta-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-(8s-cis)-5,12-naphthacenedione
pidorubicin
(7s,9s)-7-[(2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7h-tetracene-5,12-dione
epidoxorubicin
4'-epiadriamycin
56420-45-2
epirubicin
DM6 ,
epiadriamycin
DB00445
nsc-256942
4' epidoxorubicin
4' epi dxr
4' epiadriamycin
4' epi adriamycin
4' epi doxorubicin
pidorubicinum
epirubicinum
epirubicina
pidorubicina
CHEBI:47898 ,
(1s,3s)-3,5,12-trihydroxy-3-(hydroxyacetyl)-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranoside
epirubicine
pidorubicine
(7s,9s)-7-[(2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7h-tetracene-5,12-dione
CHEMBL417
farmorubicin (tn)
epirubicin (inn)
D07901
(7s,9s)-7-[(2r,4s,5r,6s)-4-azanyl-6-methyl-5-oxidanyl-oxan-2-yl]oxy-4-methoxy-6,9,11-tris(oxidanyl)-9-(2-oxidanylethanoyl)-8,10-dihydro-7h-tetracene-5,12-dione
A831042
(7s,9s)-7-[[(2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyl-2-oxanyl]oxy]-6,9,11-trihydroxy-9-(2-hydroxy-1-oxoethyl)-4-methoxy-8,10-dihydro-7h-tetracene-5,12-dione
acid, 8
bdbm43839
unii-3z8479zz5x
3z8479zz5x ,
NCGC00263918-04
AB00698552-14
epirubicin [inn]
epirubicin [who-dd]
epirubicin [vandf]
epirubicin [hsdb]
(1s,3s)-3-glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-.alpha.-l-arabino-hexopyranoside
5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-.alpha.-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8s-cis)-
epirubicin [mi]
HY-13624
AB00698552-11
SCHEMBL8582
AB00698552-13
5,12-naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-.alpha.-l-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-, (8s,10s)-
AB00698552_15
AB00698552_16
DTXSID0022987 ,
(8s,10s)-10-{[(2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy}-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-5,7,8,9,10,12-hexahydrotetracene-5,12-dione
SBI-0206890.P001
Q425122
BRD-K04548931-003-16-5
NCGC00263918-08
56420-45-2 (free base)
epirubicin free base
(8s,10s)-10-(((2r,4s,5r,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione
epi-doxorubicin
5,12-naphthacenedione,10-[(3-amino-2,3,6-trideoxy-a-l-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8s,10s)-
EN300-7410311
pidorubicinum (inn-latin)
epirubicinum (inn-latin)
pidorubicinum (latin)
epirubicine (inn-french)
epirubicina (inn-spanish)
3-glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranoside
epi dx
pidorubicine (inn-french)
l01db03
4'-epi dx
(8s-cis)-10-((3-amino-2,3,6-trideoxy-beta-l-arabino-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione
(1s,3s)-3-glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-l-arabino-hexopyranoside
pidorubicina (inn-spanish)
epirubicinum (latin)
dtxcid202987
5,12-naphthacenedione, 10-((3-amino-2,3,6-trideoxy-beta-l-arabino-hexopyranosyl)oxy-7,8,9,10-tetrahydro -6,8,(8s-cis)-

Research Excerpts

Overview

Epirubicin (EPI) is a chemotherapeutic agent belonging to the anthracycline drug class. It is widely used in tumor treatment, but has toxic and undesirable side effects on wide range of cells and hematopoietic stem cells.

ExcerptReferenceRelevance
"Epirubicin (EPI) is a chemotherapeutic agent belonging to the anthracycline drug class indicated for treating several tumors. "( Epirubicin: Biological Properties, Analytical Methods, and Drug Delivery Nanosystems.
Chorilli, M; Di Filippo, LD; Dutra, JAP; Junior, AGT; Luiz, MT; Marchetti, JM; Tofani, LB, 2023
)
3.8
"Epirubicin (Epi) is a chemotherapy agent which is commonly used in treatment of cancers. "( Smart delivery of epirubicin to cancer cells using aptamer-modified ferritin nanoparticles.
Abnous, K; Bayat, P; Dehestani, S; Hashemi, M; Taghdisi, SM; Yazdian-Robati, R, 2022
)
2.5
"Epirubicin (EPI) is a commonly used drug for the treatment of breast cancer but unfortunately can cause cardiac toxicity in patients because of dose accumulation."( Ursolic Acid Enhances the Sensitivity of MCF-7 and MDA-MB-231 Cells to Epirubicin by Modulating the Autophagy Pathway.
Jia, A; Jiang, H; Luo, H; Sun, B; Wang, Z; Zhang, P, 2022
)
1.68
"Epirubicin (EPI) is an important anticancer drug that is well-known for its cardiotoxic side effect. "( Epirubicin Alters DNA Methylation Profiles Related to Cardiotoxicity.
Herwig, R; Jennen, D; Kleinjans, J; Lienhard, M; Nguyen, N, 2022
)
3.61
"Epirubicin (EADM) is a common chemotherapeutic agent in hepatocellular carcinoma (HCC). "( Combined Treatment of Tanshinone I and Epirubicin Revealed Enhanced Inhibition of Hepatocellular Carcinoma by Targeting PI3K/AKT/HIF-1α.
Cai, C; Cai, S; Chen, J; Hong, X; Li, D; Li, J; Li, P; Lin, E; Wang, B; Yin, Z; Zeng, G; Zhang, M; Zhao, J; Zou, B, 2022
)
2.43
"Epirubicin is a potent chemotherapeutic agent for the treatment of breast cancer. "( Identification of differential gene expression related to epirubicin-induced cardiomyopathy in breast cancer patients.
Gao, J; Li, Y; Lv, D; Peng, J; Teng, H; Wang, Z; Zhao, X, 2020
)
2.25
"Epirubicin is a cytotoxic drug used in the treatment of different types of cancer and increasing evidence suggests that its target is cell membranes. "( Toxic effects of the anticancer drug epirubicin in vitro assayed in human erythrocytes.
Aguilar, LF; Colina, JR; Contreras, D; Jemiola-Rzeminska, M; Petit, K; Strzalka, K; Suwalsky, M, 2020
)
2.27
"Epirubicin is an anthracycline and is widely used in tumor treatment, but has toxic and undesirable side effects on wide range of cells and hematopoietic stem cells (HSC). "( Epirubicin induces apoptosis in osteoblasts through death-receptor and mitochondrial pathways.
Chang, KL; Chang, WT; Cheng, HL; Chiu, PR; Hsieh, BS; Hu, YC; Huang, LW; Huang, TC; Huang, YC, 2018
)
3.37
"Epirubicin is an antineoplastic agent of anthracycline antibiotic, used for treating a variety of tumor types such as lymphoma, cancer of the breast, lung, ovary and stomach. "( Labeling of epirubicin with technetium-99m: Optimization, biodistribution and scintigraphic imaging in tumor bearing mice.
Bokhari, TH; Hina, S; Rajoka, MI; Roohi, S; Sohaib, M, 2018
)
2.3
"Epirubicin is a chemotherapy agent for hepatocellular carcinoma (HCC). "( Celecoxib enhances the therapeutic efficacy of epirubicin for Novikoff hepatoma in rats.
Chan, HH; Chang, YC; Chen, YA; Chu, TH; Hu, TH; Huang, SC; Ma, YL; Tai, MH; Wang, EM; Wen, ZH; Weng, WT; Wu, DC; Wu, JC, 2018
)
2.18
"Epirubicin is a more optimal anticancer drug (as a Lipiodol suspension) than miriplatin for achieving TE4 with B-TACE."( Epirubicin is More Effective than Miriplatin in Balloon-Occluded Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma.
Iwamoto, H; Kamachi, N; Koga, H; Kuromatsu, R; Kuwano, T; Nakano, M; Niizeki, T; Noda, Y; Nomiyama, M; Okamura, S; Sakai, M; Satani, M; Shimose, S; Shirono, T; Tanaka, M; Torimura, T, 2019
)
2.68
"Epirubicin (Epr) is an effective chemotherapeutic drug; however, the clinical amenability of Epr is limited by its highly toxic interaction with normal cells. "( Development and characterization of folic acid-functionalized apoferritin as a delivery vehicle for epirubicin against MCF-7 breast cancer cells.
Gomhor J Alqaraghuli, H; Kashanian, S; Mahdavian, E; Mansouri, K; Rafipour, R, 2018
)
2.14
"Epirubicin, which is a conventional chemotherapeutic drug for gastric cancer, has innate and adaptive chemoresistance. "( DJ-1 Alters Epirubicin-induced Apoptosis via Modulating Epirubicinactivated Autophagy in Human Gastric Cancer Cells.
Feng, MH; Kong, FZ; Pan, XK; Su, F; Wang, DW; Xie, W; Xu, LH; Yang, LJ; Yang, ZS, 2018
)
2.3
"Epirubicin is a cytotoxic drug, widely used in patients with breast cancer, but its application is limited by its cardiotoxicity. "( Early detection of epirubicin-induced cardiotoxicity in patients with breast cancer.
Enescu, OA; Florescu, M; Jinga, D; Magda, LS; Vinereanu, D, 2014
)
2.17
"Epirubicin (EPI) is a broad spectrum antineoplastic drug, commonly used as a chemotherapy method to treat osteosarcoma. "( Experiments and synthesis of bone-targeting epirubicin with the water-soluble macromolecular drug delivery systems of oxidized-dextran.
Cai, L; Hu, H; Yu, L; Zhang, Y, 2014
)
2.11
"Epirubicin is an anthracycline drug used in chemotherapy to treat numerous types of malignancy, including breast cancer, acute leukemia, malignant lymphoma, lung cancer, ovarian cancer and stomach cancer."( Epirubicin directly promotes hepatitis B virus (HBV) replication in stable HBV-expressing cell lines: a novel mechanism of HBV reactivation following anticancer chemotherapy.
Chen, J; Huang, A; Huang, Y; Luo, Q; Pan, W; Tu, Z; Wang, Y; Xu, G; Xu, L; Zhan, X, 2014
)
2.57
"Epirubicin (EPI) is an anthracycline antineoplastic agent, commercially available for intravenous administration only and its oral ingestion continues to remain a challenge. "( Biodegradable polymeric nanoparticles for oral delivery of epirubicin: In vitro, ex vivo, and in vivo investigations.
Alam, MA; Iqbal, Z; Panda, AK; Singh, AT; Talegaonkar, S; Tariq, M, 2015
)
2.1
"Epirubicin (EPI) is a P-gp substrate antracycline analogue which elicits poor oral bioavailability. "( Surface decorated nanoparticles as surrogate carriers for improved transport and absorption of epirubicin across the gastrointestinal tract: Pharmacokinetic and pharmacodynamic investigations.
Alam, MA; Panda, AK; Singh, AT; Talegaonkar, S; Tariq, M, 2016
)
2.1
"Epirubicin is an anthracycline that targets DNA topoisomerase 2-α enzyme encoded by the TOP2A gene. "( A phase II study of Epirubicin in oxaliplatin-resistant patients with metastatic colorectal cancer and TOP2A gene amplification.
Andersen, DR; Brünner, N; Detlefsen, S; Jensen, NF; Nielsen, SL; Nygård, SB; Pfeiffer, P; Qvortrup, C; Stenvang, J; Tarpgaard, LS, 2016
)
2.2
"Epirubicin is an anthracycline chemotherapy agent used for treatment of several cancers including oesophageal, breast and gastric. "( Epirubicin extravasation: consequences of delayed management.
Deutsch, PG; Hale, O; Lahiri, A, 2017
)
3.34
"Epirubicin plus LD-T is an active regimen, however, the relatively high rate of cardiotoxicity together with the availability of less cardiotoxic and active trastuzumab-containing combinations precludes further evaluation of this regimen."( Epirubicin plus low-dose trastuzumab in HER2 positive metastatic breast cancer.
Bruzzi, P; Carella, C; Conte, P; De Tursi, M; Frassoldati, A; Gennari, A; Iacobelli, S; Orlandini, C; Ricevuto, E, 2009
)
3.24
"Epirubicin is an antitumor drug, particularly used in the treatment of the breast cancer. "( Change of formulation decreases venous irritation in breast cancer patients receiving epirubicin.
Egashira, N; Nagata, K; Oishi, R; Watanabe, H; Yamada, T; Yamauchi, Y, 2012
)
2.04
"Epirubicin is a common adjuvant treatment for breast cancer. "( Impact of UGT2B7 His268Tyr polymorphism on the outcome of adjuvant epirubicin treatment in breast cancer.
Brockmöller, J; Haschke-Becher, E; Huber-Wechselberger, A; Kainz, A; Krippl, P; Langsenlehner, U; Parmar, S; Renner, W; Stingl, JC, 2011
)
2.05
"Epirubicin is a stereoisomer of doxorubicin that is widely used in human oncology. "( Toxicity associated with epirubicin treatments in a large case series of dogs.
Blackwood, L; Grant, IA; Killick, DR; Marrington, AM, 2012
)
2.13
"Epirubicin is an epimer of doxorubicin with important role in the chemotherapy treatment of both early and metastatic breast cancer."( Epirubicin: is it like doxorubicin in breast cancer? A clinical review.
Bell, R; Dang, C; Khasraw, M, 2012
)
2.54
"Epirubicin HCl is a new anthracycline analog and derivative of doxorubicin. "( Epirubicin HCl toxicity in human-liver derived hepatoma G2 cells.
Fişkin, K; Ozkan, A,
)
3.02
"Epirubicin is an anthracyclin, analogous to doxorubicin, with a different toxicologic pattern."( A phase II study evaluating the cisplatin and epirubicin combination in patients with unresectable malignant pleural mesothelioma.
Berchier, MC; Berghmans, T; Collon, T; Lafitte, JJ; Lecomte, J; Mommen, P; Paesmans, M; Sculier, JP; Stach, B; Wackenier, P, 2005
)
1.31
"Epirubicin is an antineoplastic agent known as an anthracycline. "( [Proteomic approach to the effect of epirubicin on hepatoma cells at subcellular level].
Li, X; Pan, W; Qiu, F; Qiu, ZY, 2006
)
2.05
"Epirubicin is an analogue of adriamycin but differs strikingly in terms of its collateral effect, in particular being less cardiotoxic."( [Leukocyte procoagulant activity and chemotherapeutic agents: comparison between the effects of adriamycin and epiadriamycin on the procoagulant lympho/monocytic activity in vitro].
Bonifacio, E; Capodicasa, E; Ciaccio, V; Corazzi, F; de Bellis, F; Ficola, F; Romagnoli, M; Villa, A, 1994
)
1.01
"Epirubicin is a derivative of doxorubicin having more favourable therapeutic index than doxorubicin and possessing less hematologic and cardiac toxicity at comparable doses."( Sensitization of P388 murine leukemia cells to epirubicin cytotoxicity by reserpine.
Chitnis, M; Viladkar, A, 1993
)
1.26
"Epirubicin is an analogue of doxorubicin with a similar activity but less toxicity. "( A weekly schedule of epirubicin in pretreated advanced breast cancer.
Archili, C; Barni, S; Crispino, S; Lissoni, P; Paolorossi, F; Tancini, G, 1993
)
2.05
"Epirubicin is an anthracyclinic antibiotic that has been increasingly used in the treatment of a variety of malignancies. "( Production and characterization of a monoclonal antibody against epirubicin.
Baxevanis, CN; Dedoussis, GV; Gritzapis, AD; Papadopoulos, NG; Papamichail, M; Spanakos, G, 1995
)
1.97
"Epirubicin is a semisynthetic derivative of doxorubicin which has been extensively evaluated in patients with breast cancer. "( Epirubicin: a review of its efficacy as adjuvant therapy and in the treatment of metastatic disease in breast cancer.
Goa, K; Holm, K; Ormrod, D; Spencer, C, 1999
)
3.19
"Epirubicin (E) is a less cardiotoxic anthracycline which has also been combined with paclitaxel in the treatment of MBC."( Paclitaxel: epirubicin in metastatic breast cancer--a review.
Fountzilas, G; Razis, ED, 2001
)
1.41
"Epirubicin appears to be an active therapeutic option for patients with non-resectable HCC. "( Systemic chemotherapy with epirubicin for treatment of advanced or multifocal hepatocellular carcinoma.
Pohl, J; Rudi, J; Stremmel, W; Zuna, I,
)
1.87
"Epirubicin is a unique anthracycline whose introduction to the US market represents a significant advance in breast cancer treatment."( The worldwide perspective in the adjuvant treatment of primary lymph node positive breast cancer.
Glück, S, 2001
)
1.03
"Epirubicin is an agent with a lower incidence of cardiotoxicity and myelotoxicity compared with doxorubicin; and it is active in patients with non-Hodgkin's lymphoma (NHL). "( Treatment of aggressive non-Hodgkin's lymphoma with dose-intensified epirubicin in combination of cyclophosphamide, vincristine, and prednisone (CEOP-100): a phase II study.
Alici, S; Basaran, M; Bavbek, ES; Camlica, H; Dogan O, O; Eralp, Y; Onat, H; Sakar, B; Tas, F; Yaman, F, 2001
)
1.99
"4'-Epirubicin is an anthracycline analog of doxorubicin which has been shown to be similar to doxorubicin in its anti-tumor activity but significantly lower in its cardiotoxicity. "( Comparative hematopoietic toxicity of doxorubicin and 4'-epirubicin.
Buffo, MJ; Kociban, DL; OKunewick, JP, 1990
)
1.15
"Epirubicin is a new anthracycline with a potentially more favorable toxicity profile than the parent compound, doxorubicin. "( Phase I trial of adjuvant chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) for stage II breast cancer.
Brooks, BD; Jones, SE; Knox, SM; McGuffey, P; Mennel, RG; Peters, GN; Westrick, MA, 1988
)
1.96
"Epirubicin is an effective agent when used in combination chemotherapy in both low grade and high grade lymphoma with less toxicity than doxorubicin."( Combination chemotherapy including epirubicin for the management of non-Hodgkin's lymphoma.
Al-Ismail, SA; Gough, J; Whittaker, JA, 1987
)
1.27
"Epirubicin appears to be an effective drug for the treatment of breast cancer and, given at equal doses, is less toxic than doxorubicin."( Phase II study of doxorubicin versus epirubicin in advanced breast cancer.
Bonadonna, G; Bonfante, V; Brambilla, C; Crippa, F; Ferrari, L; Rossi, A; Villani, F, 1986
)
1.27
"Epirubicin is a new anthracycline with reduced cardiac toxicity, but preserved efficacy in the treatment of patients with advanced breast cancer."( A prospective randomized comparison of epirubicin and doxorubicin in patients with advanced breast cancer.
Casper, ES; Cassidy, C; Currie, V; Geller, NL; Hakes, TB; Jain, KK; Kaufman, RJ; Petroni, GR; Schwartz, W; Young, CW, 1985
)
1.26
"Epirubicin is a new derivative of doxorubicin characterized by an improved spectrum of activity and a better therapeutic index. "( Clinical toxicity of 4'-epi-doxorubicin (epirubicin).
Di Pietro, N; Ganzina, F; Magni, O, 1985
)
1.98

Effects

Epirubicin has a unique metabolic pathway, glucuronidation, that may result in more rapid plasma clearance and reduced toxicity as compared with doxorubsicin. The recommended maximum cumulative dose is almost double that ofDoxorubicins.

Epirubicin has been widely used for chemotherapeutic treatment of gastric cancer. intrinsic and acquired chemoresistance remains an obstacle to successful management. EpirubICin has great significance as it has propitious anticancer potential with lesser cardiotoxicity.

ExcerptReferenceRelevance
"Epirubicin also has a distinct safety profile compared to doxorubicin with regard to cardiotoxicity."( Adjuvant chemotherapy for early breast cancer: optimal use of epirubicin.
Glück, S,
)
1.09
"Epirubicin has a lower propensity to produce cardiotoxic effects than doxorubicin, and its recommended maximum cumulative dose is almost double that of doxorubicin, thus allowing for more treatment cycles and/or higher doses of epirubicin."( Epirubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cancer chemotherapy.
Faulds, D; Plosker, GL, 1993
)
2.45
"Epirubicin has a spectrum very similar to doxorubicin but lesser toxicity."( New anthracycline antitumor antibiotics.
Green, MD; Muggia, FM, 1991
)
1
"Epirubicin has a unique metabolic pathway, glucuronidation, that may result in more rapid plasma clearance and reduced toxicity as compared with doxorubicin."( Phase I and II agents in cancer therapy: I. Anthracyclines and related compounds.
Fuks, JZ; Wadler, S; Wiernik, PH,
)
0.85
"Epirubicin has great significance as it has propitious anticancer potential with lesser cardiotoxicity and faster elimination from the body."( RNA targeting by an anthracycline drug: spectroscopic and
Charak, S; Mehrotra, R; Shandilya, M, 2020
)
1.28
"Epirubicin has been widely used for chemotherapeutic treatment of gastric cancer; however, intrinsic and acquired chemoresistance remains an obstacle to successful management. "( Identification of GAS1 as an epirubicin resistance-related gene in human gastric cancer cells with a partially randomized small interfering RNA library.
Fan, D; Gang, Y; He, L; Jin, H; Li, T; Liu, Z; Pan, Y; Qiao, T; Tie, J; Wang, H; Xia, L; Yao, L; Zhang, Y; Zhao, L, 2009
)
2.09
"Epirubicin (EPI) has strong cytotoxic activity that makes it a potential candidate for the treatment of malignant gliomas. "( Epirubicin exhibits potent anti-tumor activity in an animal model of malignant glioma when administered via controlled-release polymers.
Bekelis, K; Brem, H; Hertig, S; Kosztowski, T; Legnani, FG; Li, KW; Olivi, A; Recinos, VR; Tyler, BM; Vick, D; Ziegler, SG, 2010
)
3.25
"Epirubicin has been incorporated into most of the anthracycline containing chemotherapy combinations in well-conducted clinical trials involving large numbers of patients."( Epirubicin: is it like doxorubicin in breast cancer? A clinical review.
Bell, R; Dang, C; Khasraw, M, 2012
)
2.54
"Epirubicin HCl has more favorable therapeutic index than doxorubicin and possesses less hematologic and cardiac toxicity at comparable doses."( Epirubicin HCl toxicity in human-liver derived hepatoma G2 cells.
Fişkin, K; Ozkan, A,
)
2.3
"Epirubicin also has a distinct safety profile compared to doxorubicin with regard to cardiotoxicity."( Adjuvant chemotherapy for early breast cancer: optimal use of epirubicin.
Glück, S,
)
1.09
"Epirubicin (EPX) has been found to be active in hormone-refractory prostate cancer (HRPC) patients. "( Feasibility of 21-day continuous infusion of epirubicin in hormone-refractory prostate cancer patients.
Berruti, A; Bitossi, R; Dogliotti, L; Gorzegno, G; Guercio, S; Mosca, A; Ostellino, O; Poggio, M; Porpiglia, F; Scarpa, RM; Tampellini, M,
)
1.83
"Epirubicin has a lower propensity to produce cardiotoxic effects than doxorubicin, and its recommended maximum cumulative dose is almost double that of doxorubicin, thus allowing for more treatment cycles and/or higher doses of epirubicin."( Epirubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cancer chemotherapy.
Faulds, D; Plosker, GL, 1993
)
2.45
"Epirubicin has been found to be as effective as doxorubicin at equimolar doses but significantly better tolerated, especially in terms of alopecia, leucopenia, and cardiac toxicity."( Premenopausal patients with node-positive resectable breast cancer. Preliminary results of a randomised trial comparing 3 adjuvant regimens: FEC 50 x 6 cycles vs FEC 50 x 3 cycles vs FEC 75 x 3 cycles. The French Adjuvant Study Group.
Devaux, Y; Fargeot, P; Fumoleau, P; Kerbrat, P; Mercier, M; Mihura, J; Namer, M; Schraub, S; Vo Van, ML, 1993
)
1.01
"Epirubicin has been extensively investigated in patients with breast cancer and has been found to be a highly effective agent, both for the treatment of patients with metastatic disease and as an adjuvant therapy. "( Epirubicin: a review of its efficacy as adjuvant therapy and in the treatment of metastatic disease in breast cancer.
Goa, K; Holm, K; Ormrod, D; Spencer, C, 1999
)
3.19
"Epirubicin has a spectrum very similar to doxorubicin but lesser toxicity."( New anthracycline antitumor antibiotics.
Green, MD; Muggia, FM, 1991
)
1
"Epirubicin has a unique metabolic pathway, glucuronidation, that may result in more rapid plasma clearance and reduced toxicity as compared with doxorubicin."( Phase I and II agents in cancer therapy: I. Anthracyclines and related compounds.
Fuks, JZ; Wadler, S; Wiernik, PH,
)
0.85
"Epirubicin has limited activity as a single agent against head and neck tumors or non-small-cell lung cancer, but may be beneficial in combination with other agents."( Epirubicin: a review of the pharmacology, clinical activity, and adverse effects of an adriamycin analogue.
Cersosimo, RJ; Hong, WK, 1986
)
2.44
"Thepirubicin which has been shown not to induce delayed cardiomyopathy has no effect on superoxide release from the cells."( Interaction of anthracycline antibiotics with human neutrophils: superoxide production, free radical formation and intracellular penetration.
Bertelli, A; Rossini, D; Schinetti, ML, 1987
)
0.83

Actions

Epirubicin can produce remissions in patients with previously treated myeloma who have not received prior doxorubicine. EpirubICin may cause transient cardiac arrhythmias and alterations of the electrocardiogram, but has a lower propensity to produce cardiotoxic effects.

ExcerptReferenceRelevance
"Epirubicin can cause myocardial necrosis, while trastuzumab can cause cardiomyopathy without myocardial necrosis."( High-sensitivity cardiac troponin I detection for 2 types of drug-induced cardiotoxicity in patients with breast cancer.
Kawahara, E; Mokuyasu, S; Seto, T; Suzuki, Y; Tokuda, Y, 2015
)
1.14
"Epirubicin has a lower propensity to produce cardiotoxic effects than doxorubicin, and its recommended maximum cumulative dose is almost double that of doxorubicin, thus allowing for more treatment cycles and/or higher doses of epirubicin."( Epirubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cancer chemotherapy.
Faulds, D; Plosker, GL, 1993
)
2.45
"Epirubicin may cause transient cardiac arrhythmias and alterations of the electrocardiogram."( Epirubicin: a review of the pharmacology, clinical activity, and adverse effects of an adriamycin analogue.
Cersosimo, RJ; Hong, WK, 1986
)
2.44
"Epirubicin can produce remissions in patients with previously treated myeloma who have not received prior doxorubicin."( Phase I-II study of epirubicin in multiple myeloma.
Case, DC; Ervin, TJ; Gams, R; Oldham, FB; Paul, SD; Sonneborn, HL, 1988
)
1.32

Treatment

Epirubicin-treated patients had significantly higher heart rate, more abnormal echocardiograms and LVEF by magnetic resonance imaging (MRI) compared to CMF-treated ones. The drug also increased the NKG2D-mediated NK sensitivity of HCC cells.

ExcerptReferenceRelevance
"In epirubicin-treated cells, knockdown of TFAM counteracted the attenuated DSB formation due to metformin pretreatment, and inhibition of mitochondrial fragmentation with Mdivi-1 decreased DSB formation but increased TFAM expression."( Metformin Alleviates Epirubicin-Induced Endothelial Impairment by Restoring Mitochondrial Homeostasis.
Cheng, S; Jia, H; Sun, Q; Wang, J; Wang, Y, 2022
)
1.55
"Epirubicin-treated macrophages displayed reduced acetylation of histone 3 lysine 9 (H3K9ac), suggesting anti-inflammatory epigenetic imprinting as one underlying mechanism."( Transcriptional Suppression of the NLRP3 Inflammasome and Cytokine Release in Primary Macrophages by Low-Dose Anthracyclines.
Bruns, T; Gardey, E; Kirchberger-Tolstik, T; Köse-Vogel, N; Reuken, PA; Stallmach, A; Stengel, S, 2019
)
1.24
"Epirubicin treatment resulted in a decrease in the number of primordial, primary, secondary and antral follicles, an increase in the number of atretic follicles and ovarian cell apoptosis, a decrease in estradiol and AMH levels, an increase in FSH levels, and estrous cycle arrest. "( Menstrual blood derived mesenchymal stem cells combined with Bushen Tiaochong recipe improved chemotherapy-induced premature ovarian failure in mice by inhibiting GADD45b expression in the cell cycle pathway.
Du, X; Guo, F; Han, Y; Hao, S; Ma, R; Ma, X; Xia, T; Yan, Z; Zhang, Y; Zhou, Y, 2019
)
1.96
"Epirubicin treatment also decreased glutathione resulting in the induction of apoptosis."( Progesterone augments epirubicin-induced apoptosis in HA22T/VGH cells by increasing oxidative stress and upregulating Fas/FasL.
Chang, KL; Chang, WT; Cheng, HL; Hsieh, BS; Lee, KT, 2014
)
1.44
"Epirubicin treatment dose-dependently inhibited the growth of HA22T/VGH cells."( Progesterone increases apoptosis and inversely decreases autophagy in human hepatoma HA22T/VGH cells treated with epirubicin.
Chang, KL; Chang, WT; Cheng, HL; Chiu, CC; Hsieh, BS; Lee, KT, 2014
)
1.33
"Epirubicin-treated patients had significantly higher heart rate, more abnormal echocardiograms and LVEF by magnetic resonance imaging (MRI) compared to CMF-treated ones."( Cardiac assessment of early breast cancer patients 18 years after treatment with cyclophosphamide-, methotrexate-, fluorouracil- or epirubicin-based chemotherapy.
Aftimos, P; Ameye, L; Beauduin, M; Bejarano Hernández, S; Cornez, N; de Azambuja, E; Delhaye, F; Diaz, M; Focan, C; Lemort, M; Paesmans, M; Piccart-Gebhart, M; Shih-Li, C; Suter, T; Vandenbossche, S; Vindevoghel, A, 2015
)
1.34
"Epirubicin treatment also enhanced the NKG2D-mediated NK sensitivity of HCC cells."( Anticancer chemotherapy inhibits MHC class I-related chain a ectodomain shedding by downregulating ADAM10 expression in hepatocellular carcinoma.
Hayashi, N; Hiramatsu, N; Ishida, H; Kanto, T; Kohga, K; Miyagi, T; Ohkawa, K; Takehara, T; Tatsumi, T, 2009
)
1.07
"Epirubicin treatment up-regulated death receptor 4 (DR-4) and DR-5 expression and down-regulated FLIP expression, thereby enhancing the activation of procaspase 3, procaspase 8, and procaspase 9."( Epirubicin potentiates recombinant adeno-associated virus type 2/5-mediated TRAIL expression in fibroblast-like synoviocytes and augments the antiarthritic effects of rAAV2/5-TRAIL.
Diao, Z; Liu, Y; Shi, J; You, X; Yuan, H; Zheng, D; Zhou, J; Zhu, J, 2012
)
2.54
"Epirubicin-treated GRP78 knockdown cells resulted in more inactivated Akt pathway members, such as phosphorylated Akt and GSK-3β, as well as downstream targets of β-catenin expression."( GRP78 knockdown enhances apoptosis via the down-regulation of oxidative stress and Akt pathway after epirubicin treatment in colon cancer DLD-1 cells.
Chang, YJ; Chen, CH; Huang, YP; Li, ZL, 2012
)
1.32
"Treatment with epirubicin (1.18 µg/ml, IC50 dose for 24 h) and TRAIL (100 ng/ml for 24 h) led to a marked increase in the inhibition rate of cell proliferation and apoptosis compared to treatment with epirubicin or TRAIL alone (P<0.05)."( Epirubicin enhances TRAIL-induced apoptosis in gastric cancer cells by promoting death receptor clustering in lipid rafts.
Liu, J; Liu, Y; Luo, Y; Qu, J; Qu, X; Xu, L; Zhang, L; Zhang, Y,
)
1.91
"Treatment with epirubicin in GRP78 knockdown DLD-1 cells enhanced apoptosis and was associated with decreased production of intracellular ROS. "( GRP78 knockdown enhances apoptosis via the down-regulation of oxidative stress and Akt pathway after epirubicin treatment in colon cancer DLD-1 cells.
Chang, YJ; Chen, CH; Huang, YP; Li, ZL, 2012
)
0.95

Toxicity

Epirubicin was significantly less toxic than doxorubicins to normal hematopoetic cells. The incidence of CHF after an epirubic in/paclitaxel regimen is low up to cumulative epirUBicin doses of 990 mg/m(2)

ExcerptReferenceRelevance
" The toxic activity of MMC in mouse bone marrow was significantly reduced or completely abolished after its inclusion in PBCN."( Diminished genotoxicity of mitomycin C and farmorubicin included in polybutylcyanoacrylate nanoparticles.
Balansky, RM; Blagoeva, PM; Mircheva, TJ; Simeonova, MI, 1992
)
0.28
"01) less toxic than doxorubicin."( Comparative hematopoietic toxicity of doxorubicin and 4'-epirubicin.
Buffo, MJ; Kociban, DL; OKunewick, JP, 1990
)
0.52
" The results justify further studies on the antineoplastic and adverse effects pertaining to interaction between anthracyclines and antiemetics."( Epirubicin cytotoxicity but not oxygen radical formation is enhanced by four different antiemetics.
Grankvist, K; Henriksson, R, 1989
)
1.72
" injection in the mouse will thus spread into brain regions lacking a BBB where it produces toxic lesions in the same way as previously reported for the parent compound, doxorubicin."( Distribution and toxic effects of intravenously injected epirubicin on the central nervous system of the mouse.
Bigotte, L; Olsson, Y, 1989
)
0.52
"In 34 patients with primary advanced breast cancer, intra-arterial administration of ADR (50 mg X 3, total dose 150 mg, 10 cases), 4' epi ADR (50 mg X 3, 150 mg, 8 cases; 70 mg X 3, 210 mg, 10 cases) and THP-ADR (50 mg X 3, 150 mg, 6 cases) was performed, and its effects and side effect were analyzed."( [Intra-arterial infusion chemotherapy of advanced breast cancer--effects and side effects of adriamycin, 4'-epi-adriamycin and THP-adriamycin].
Asaishi, K; Hayasaka, H; Mikami, T; Narimatsu, E; Okazaki, A; Okazaki, M; Okazaki, Y; Sato, H; Toda, K; Watanabe, Y, 1989
)
0.28
"We report on preliminary experience with a modified M-VAC (methotrexate, vinblastine, adriamycin and cisplatin) regimen in which adriamycin was replaced by the less toxic 4-epirubicin at equal doses (M-VEC)."( [Polychemotherapy using the M-VEC protocol (methotrexate, vinblastine, epirubicin, cisplatin) in advanced urinary bladder cancer--effectiveness and toxicity].
Bäuerle, K; Bub, P; Eisenberger, F; Jipp, P; Rassweiler, J; Rüther, U, 1989
)
0.7
" The biochemical mechanisms responsible for endocardial fibrosis are unknown, but drug induced damage to the endocardium, possibly mediated via hormonal or humoral agents, may feature in the initial phase of the toxic process."( Chronic anthracycline cardiotoxicity: haemodynamic and histopathological manifestations suggesting a restrictive endomyocardial disease.
Baandrup, U; Mortensen, SA; Olsen, HS, 1986
)
0.27
"The toxicity of combination chemotherapy is significant, with the most prominent side effect being myelosuppression."( M-VEC (methotrexate, vinblastine, epirubicin, and cisplatin) with granulocyte colony-stimulating factor for the treatment of urothelial cancer: an effective and safe chemotherapy regimen.
Igawa, M; Kadena, H; Ueda, M; Usui, T, 1994
)
0.57
" As far as the toxic effects of this treatment are concerned, mucositis of a minimum grade and leukopenia greater than grade 3 occurred in 5% and 10% of the patients, respectively; there were no cases of nadir sepsis and drug-related death."( M-VEC (methotrexate, vinblastine, 4'-epirubicin and cisplatin) combined with glycosylated recombinant human granulocyte colony-stimulating factor (rhG-CSF) for the treatment of transitional cell carcinoma of urothelium: reduction in toxicity produced by r
Igawa, M; Kadena, H; Ueda, M; Usui, T, 1994
)
0.56
"This study demonstrates that dexrazoxane can be safely combined with escalating doses of epirubicin at dose ratios of 5 to 9:1 without having an adverse impact on toxicity."( Comparative study of the pharmacokinetics and toxicity of high-dose epirubicin with or without dexrazoxane in patients with advanced malignancy.
Basser, RL; Cebon, J; Duggan, G; Green, MD; Mihaly, G; Rosenthal, MA; Sobol, MM, 1994
)
0.75
"Cardiotoxicity is a well recognized side effect of anthracyclines (doxorubicin and epirubicin) or antracenadiones (mitoxantrone) at cumulative or high doses."( Late cardiac toxicity of doxorubicin, epirubicin, and mitoxantrone therapy for Hodgkin's disease in adults.
Arévila, N; Avilés, A; Díaz Maqueo, JC; García, R; Gómez, T; Nambo, MJ, 1993
)
0.78
" D-Verapamil was only about half as toxic as racemic verapamil and this too is consistent with clinical observations."( Identification of a multidrug resistance modulator with clinical potential by analysis of synergistic activity in vitro, toxicity in vivo and growth delay in a solid human tumour xenograft.
Bicknell, SR; Hamilton, T; Kaye, SB; Morrison, JG; Plumb, JA; Setanoians, A; Wishart, GC, 1994
)
0.29
" In mice, the acute LD50 of hydroxyrubicin was about 3-fold higher than that of doxorubicin (79."( Removal of the basic center from doxorubicin partially overcomes multidrug resistance and decreases cardiotoxicity.
Burke, TG; Perez-Soler, R; Priebe, W; Van, NT, 1993
)
0.29
" We conclude that the combination paclitaxel/epirubicin is safe for patients with metastatic breast cancer and, at this early evaluation, shows promising antitumor activity."( Phase I study of paclitaxel and epirubicin in patients with metastatic breast cancer: a preliminary report on safety.
Catimel, G; Chazard, M; Dieras, V; Dumortier, A; Garet, F; Graffand, N; Guastalla, JP; Kayitalire, L; Pellae-Cosset, B; Pouillart, P; Soler-Michel, P; Spielmann, M, 1996
)
0.84
" The use of DEX did not add to the toxicity of the anthracyclines, nor was there clear evidence of an adverse impact of the agent on antitumor activity of the chemotherapeutic regimen."( European trials with dexrazoxane in amelioration of doxorubicin and epirubicin-induced cardiotoxicity.
Lopez, M; Vici, P, 1998
)
0.54
" Furthermore, we evaluated the times for hematopoietic reconstitution in a group of five BC patients in the high-risk adjuvant situation who underwent HD chemotherapy and hematopoietic rescue with positive/negative selected stem cells and compared it with our own data from 10 BC patients who, after identical HD therapy, received only positively selected CD34+ cells and 14 patients who, after identical HD therapy, received autografts purged by incubation with toxic ether lipids (ET-18-OCH3)."( Efficacy and safety of simultaneous immunomagnetic CD34+ cell selection and breast cancer cell purging in peripheral blood progenitor cell samples used for hematopoietic rescue after high-dose therapy.
Berdel, WE; Cassens, U; Fietz, T; Hilgenfeld, E; Hoffmann, M; Hoppe, B; Kienast, J; Knauf, WU; Koenigsmann, M; Mohr, M; Sibrowski, W; Thiel, E, 1999
)
0.3
"Acute toxic effects of the antineoplastic anthraquinones carminomycin, epirubicin, idarubicin and mitoxantrone were studied in primary cultures of cardiomyocytes, which were isolated from adult rats."( Anthraquinone-induced cell injury: acute toxicity of carminomycin, epirubicin, idarubicin and mitoxantrone in isolated cardiomyocytes.
Andersson, BS; Carlberg, M; Eksborg, S; Sundberg, M; Vidal, RF, 1999
)
0.77
"This study shows that the incidence of CHF after an epirubicin/paclitaxel regimen is low up to cumulative epirubicin doses of 990 mg/m(2), thus allowing the safe administration of this regimen even in patients who received epirubicin in the adjuvant setting."( Cardiotoxicity of epirubicin/paclitaxel-containing regimens: role of cardiac risk factors.
Bengala, C; Bruzzi, P; Conte, PF; Danesi, R; Del Tacca, M; Donati, S; Gennari, A; Orlandini, C; Salvadori, B, 1999
)
0.89
"The toxicity of most drugs is associated with their enzymatic conversion to toxic metabolites."( Saccharomyces cerevisiae as an eukaryotic cell model to assess cytotoxicity and genotoxicity of three anticancer anthraquinones.
Buschini, A; Poli, P; Rossi, C, 2003
)
0.32
" Since lipid peroxidation has also been suggested to mediate anthracycline-induced heart failure, we designed a study aimed at investigating whether a DHA-enriched diet coupled with controlled oxidative conditions prevents or aggravates this serious side effect in vivo."( Anthracycline-induced cardiac toxicity is not increased by dietary omega-3 fatty acids.
Aubourg, L; Bonnet, P; Bougnoux, P; Chajès, V; Germain, E; Grangeponte, MC, 2003
)
0.32
"Chemotherapy-associated enterocolitis is a very rare but potentially lethal side effect of cytostatic therapy."( [Chemotherapy-associated enterocolitis--a rare but potentially lethal side effect of adjuvant breast cancer treatment: a case report].
Friese, K; Janni, JW; Klanner, E; Rack, B; Sommer, H, 2004
)
0.32
"Early postoperative single high dose intravesical instillation of epirubicin combined with repeated lower doses of the same drug every month may be an efficient and safe regimen to prevent the primary superficial bladder carcinoma from recurrence."( [Efficacy and safety of different dosages of intravesical epirubicin instillation for prevention of primary superficial bladder carcinoma from recurrence].
Chen, BJ; Lin, GB; Rong, RM; Wu, ZB; Wu, ZM, 2005
)
0.81
" In patients with Grade 3 or more, leukocytopenia was observed in 7 patients and diarrhea in 1 as adverse events."( [Clinical examination of safety and effectiveness of primary chemotherapy with CEF followed by docetaxel in preoperative breast cancer].
Dohden, K; Hattori, M; Hayashi, H; Hosokawa, O; Kaizaki, Y; Kiya, T; Morishita, M; Morita, M; Ohta, K, 2006
)
0.33
" Rates of cycle delay, discontinuation, dose reduction, and adverse events were similar in both groups."( Randomised trial: survival benefit and safety of adjuvant dose-dense chemotherapy for node-positive breast cancer.
Blohmer, JU; Breitbach, GP; Budner, M; Elling, D; Kohls, A; Krocker, J; Kümmel, S; Morack, G, 2006
)
0.33
"Neoadjuvant chemotherapy can reduce surgery complexity and is safe when associated with intraoperative evaluation of the surgical margins, without changing the local recurrence rate, disease-free survival, and overall survival."( The safe association of intraoperative evaluation of surgical margins and neoadjuvant chemotherapy in breast cancer larger than 3 centimeters.
de Barros, AC; Kurbet, S; Pinotti, JA,
)
0.13
" annulatum have a substantial cytoprotective potential against the toxic effects induced by epirubicin and necessitates further detailed pharmacological evaluation of these compounds as possible chemoprotective/radioprotective agents."( Cytoprotective effects of 5 benzophenones and a xanthone from Hypericum annulatum in models of epirubicin-induced cytotoxicity: SAR-analysis and mechanistic investigations.
Girreser, U; Karaivanova, M; Kitanov, GM; Momekov, G; Nedialkov, PT; Tzanova, T; Zh Zheleva-Dimitrova, D, 2006
)
0.77
" In conclusion, weekly epirubicin appears to be a safe adjuvant chemotherapy option for early breast cancer patients with chronic renal failure undergoing hemodialytic treatment."( Safety of epirubicin adjuvant chemotherapy in a breast cancer patient with chronic renal failure undergoing hemodialytic treatment.
Colozza, M; Crinò, L; Gori, S; Mosconi, AM; Rulli, A; Sidoni, A,
)
0.84
"Two authors independently performed the study selection, quality assessment and data-extraction including adverse effects."( Different anthracycline derivates for reducing cardiotoxicity in cancer patients.
Caron, HN; Kremer, LC; Michiels, EM; van Dalen, EC, 2006
)
0.33
" The most common grade 3/4 adverse events were neutropenia (26."( [Efficacy and toxicity of combination treatment with epirubicin (EPI) plus docetaxel (DOC) in advanced breast cancer].
Hata, Y; Taguchi, K; Takahashi, H; Takahashi, M; Tamura, M; Todo, S; Watanabe, K, 2006
)
0.58
"Intra-arterial chemotherapy is an effective and safe treatment for locally advanced breast cancer in the elderly."( Intra-arterial chemotherapy: a safe treatment for elderly patients with locally advanced breast cancer.
Cantore, M; Della Seta, R; Fiorentini, G; Mambrini, A; Muttini, MP; Pacetti, P; Palmieri, B; Paolucci, R; Sanguinetti, F,
)
0.13
" The rates of severe taxane-related toxic effects and thrombocytopenia, although low overall, are significantly increased with the dose-dense sequential regimen."( Postoperative dose-dense sequential chemotherapy with epirubicin, paclitaxel and CMF in patients with high-risk breast cancer: safety analysis of the Hellenic Cooperative Oncology Group randomized phase III trial HE 10/00.
Bafaloukos, D; Briasoulis, E; Dafni, U; Dimitrakakis, K; Dimopoulos, AM; Fountzilas, G; Gogas, H; Kalofonos, HP; Karanikiotis, C; Karina, M; Linardou, H; Makrantonakis, P; Markopoulos, C; Papadimitriou, C; Papakostas, P; Pectasides, D; Pisanidis, N; Polichronis, A; Samantas, E; Skarlos, D; Stathopoulos, GP; Tzorakoeleftherakis, E; Varthalitis, I; Xiros, N, 2008
)
0.59
" Blood routine test were done every cycle, liver and kindey function were examined and adverse effects were recorded after every cycle."( [Comparison of tolerance and toxicity of CEF-100 regimen versus CEF-60 regimen as adjuvant therapy for breast cancer].
Hao, XM; Hui, R; Zhang, J; Zhang, M, 2007
)
0.34
" Adverse effects of digestive tract and damage of liver function in CEF-100 group were more severe than that in CEF-60 group (P <0."( [Comparison of tolerance and toxicity of CEF-100 regimen versus CEF-60 regimen as adjuvant therapy for breast cancer].
Hao, XM; Hui, R; Zhang, J; Zhang, M, 2007
)
0.34
"Our data shows that high dose epirubicin-containing CEF regimen is safe and tolerable for postoperative chemotherapy of breast cancer patient, and the adverse effects could be relieved by marrow support and liver-protection therapy."( [Comparison of tolerance and toxicity of CEF-100 regimen versus CEF-60 regimen as adjuvant therapy for breast cancer].
Hao, XM; Hui, R; Zhang, J; Zhang, M, 2007
)
0.63
" It also seemed to be related to a greater dose reduction, which may explain that toxic episodes and delays occurred more frequently in the younger patients receiving the full scheduled dose."( Retrospective study of efficacy and toxicity on patients older than 70 years within a randomized clinical trial of two cisplatin-based combinations in patients with small-cell lung cancer.
Artal-Cortes, A; Barneto, I; Camps, C; Carrato, A; Gómez-Codina, J; González-Larriba, JL; Isla, D; Rosell, R; Safont, MJ; Sirera, R, 2009
)
0.35
" No patients developed progressive disease and major adverse events except for febrile neutropenia in ten patients."( [Safety and efficacy of weekly paclitaxel followed by FEC100 as primary systemic therapy for breast cancer].
Hirai, Y; Kiyoi, M; Miyasaka, M; Naito, K; Nakamura, R; Ohta, F; Okamura, Y; Oura, S; Shimizu, Y; Tamaki, T; Yoshimasu, T, 2009
)
0.35
"Transarterial treatments can be considered safe in patients with Child class A and B cirrhosis when an adjusted dose of epirubicin is used according to body surface, severity of liver disease, and white blood cell count."( Arterial chemoembolization/embolization and early complications after hepatocellular carcinoma treatment: a safe standardized protocol in selected patients with Child class A and B cirrhosis.
Biondo, D; D'Antoni, A; Fili', D; Gridelli, B; Luca, A; Maruzzelli, L; Miraglia, R; Petridis, I; Pietrosi, G; Riccardo, V; Vizzini, GB, 2009
)
0.56
"EP-UFT with lower UFT doses and without leucovorin support is a safe and effective regimen as first -line treatment of MGC."( Efficacy and toxicity of lower dose UFT without leucovorin in metastatic gastric cancer patients.
Alacacioglu, A; Meydan, N; Oztop, I; Somali, I; Tarhan, MO; Yilmaz, U,
)
0.13
"Two authors independently performed study selection, assessment of risk of bias and data-extraction including adverse effects."( Different anthracycline derivates for reducing cardiotoxicity in cancer patients.
Caron, HN; Kremer, LC; Michiels, EM; van Dalen, EC, 2010
)
0.36
"Two authors independently performed study selection, assessment of risk of bias and data-extraction including adverse effects."( Different anthracycline derivates for reducing cardiotoxicity in cancer patients.
Caron, HN; Kremer, LC; Michiels, EM; van Dalen, EC, 2010
)
0.36
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
"The majority of patients with Hodgkin's disease can be cured by combination of polychemotherapy and radiotherapy (RT) that can produce late toxic pulmonary and cardiac effects which often remain at a subclinical level."( Cardiopulmonary toxicity of different chemoradiotherapy combined regimens for Hodgkin's disease.
Bonfante, V; Busia, A; Laffranchi, A; Villani, F; Viviani, S, 2010
)
0.36
"These data confirm that the combination of mediastinal RT with the more commonly used polychemotherapy regimens produce late toxic effects."( Cardiopulmonary toxicity of different chemoradiotherapy combined regimens for Hodgkin's disease.
Bonfante, V; Busia, A; Laffranchi, A; Villani, F; Viviani, S, 2010
)
0.36
"NE regimen is safe with good long-term survival rate, and thus could be recommended as a postoperative chemotherapy regimen for breast cancer."( Clinical comparison of safety and efficacy of vinorelbine/epirubicin (NE) with fluorouracil/epirubicin/cyclophosphamide (FEC).
Huang, XE; Jiang, Y; Jin, X; Tang, JH; Xu, HX; Xu, X; Yan, PW, 2010
)
0.6
"GSTP1 polymorphism was associated with the chemotherapy response or adverse effects of EPI and CTX regimens."( Polymorphisms of GSTP1 is associated with differences of chemotherapy response and toxicity in breast cancer.
Chen, GJ; Lin, DX; Lü, N; Sun, T; Wang, X; Xu, BH; Yu, DK; Zhang, BL; Zhang, BN; Zheng, S, 2011
)
0.37
" SERMS are a safe and effective intervention in dysphagic patients undergoing neoadjuvant chemotherapy for esophageal cancer."( Safety and efficacy of self-expanding removable metal esophageal stents during neoadjuvant chemotherapy for resectable esophageal cancer.
Gilani, SQ; Jain, PK; Pellen, MG; Razack, A; Sabri, S, 2012
)
0.38
" No grade 4 adverse event occurred."( Feasibility and safety of weekly sequential epirubicin-paclitaxel as adjuvant treatment for operable breast cancer patients older than 70 years.
Arnould, L; Coudert, B; Favier, L; Fumoleau, P; Ghiringhelli, F; Ladoire, S; Pfitzenmeyer, P; Quipourt, V; Rambach, L, 2011
)
0.63
" This regimen is safe in terms of hematologic, nonhematologic, and cardiac toxicities, and showed encouraging efficacy, justifying further studies in geriatric patients."( Feasibility and safety of weekly sequential epirubicin-paclitaxel as adjuvant treatment for operable breast cancer patients older than 70 years.
Arnould, L; Coudert, B; Favier, L; Fumoleau, P; Ghiringhelli, F; Ladoire, S; Pfitzenmeyer, P; Quipourt, V; Rambach, L, 2011
)
0.63
" Because of an apparent high incidence of side effects, especially febrile neutropenia (FN) and non-hematologic side effects, the DBCG (The Danish Breast Cancer Cooperative Group) initiated a retrospective study of adverse reactions to the newly introduced regime and all patients were offered primary prophylaxis with growth factors (G-CSF) pr 1/1-2008."( TAXTOX - a retrospective study regarding the side effects of docetaxel given as part of the adjuvant treatment to patients with primary breast cancer in Denmark from 2007 to 2009.
Eckhoff, L; Knoop, A; Moeller, S; Nielsen, M, 2011
)
0.37
" The incidence of non-hematological adverse events, in 2007 and 2008 combined, was for neuropathy 35%, mucositis 75%, muscle and joint pain 53%, skin rash 25% and fatigue 43% (all grades)."( TAXTOX - a retrospective study regarding the side effects of docetaxel given as part of the adjuvant treatment to patients with primary breast cancer in Denmark from 2007 to 2009.
Eckhoff, L; Knoop, A; Moeller, S; Nielsen, M, 2011
)
0.37
" The incidence of non-hematological adverse events had been reported in some, but not all adjuvant taxanes studies."( TAXTOX - a retrospective study regarding the side effects of docetaxel given as part of the adjuvant treatment to patients with primary breast cancer in Denmark from 2007 to 2009.
Eckhoff, L; Knoop, A; Moeller, S; Nielsen, M, 2011
)
0.37
" Pre-treatment with aprepitant did not increase adverse events including constipation and elevation of alanine transaminase."( [Efficacy and safety of aprepitant in patients with breast cancer].
Aogi, K; Eguchi, H; Hara, F; Kiyoto, S; Matsuhisa, T; Osumi, S; Oze, I; Tagashira, H; Takabatake, D; Takahashi, M; Takashima, S, 2011
)
0.37
" The time of reccurrence and adverse effects were recorded."( [Evaluation of the efficacy and safety of intravesical instillation with gemcitabine after first-line intravesical chemotherapy failure in the treatment of non-muscle-invasive bladder cancer].
Cao, M; Chen, HG; Ma, CK; Ma, J; Xue, W, 2011
)
0.37
"FPC regimen is safe with superior long-term survival rate when compared with FEC, thus could be recommended as a postoperative chemotherapy regimen for Chinese patients with breast cancer."( Clinical comparison on the safety and efficacy of fluorouracil/pirarubicin/cyclophosphamide (FPC) with fluorouracil/ epirubicin/cyclophosphamide (FEC) as postoperative adjuvant chemotherapy in breast cancer.
Huang, XE; Li, CG; Li, Y; Tang, JH, 2011
)
0.58
" Thirty-six (11%) adverse events resulted in hospitalization in 33 (24%) patients, of which 15 were neutropenic and 9 pyrexic."( Toxicity associated with epirubicin treatments in a large case series of dogs.
Blackwood, L; Grant, IA; Killick, DR; Marrington, AM, 2012
)
0.68
" We have characterized how amrubicin converted to ROS or secondary alcohol metabolite in comparison with doxorubicin (that formed both toxic species) or epirubicin (that lacked ROS formation and showed an impaired conversion to alcohol metabolite)."( Pharmacokinetic characterization of amrubicin cardiac safety in an ex vivo human myocardial strip model. II. Amrubicin shows metabolic advantages over doxorubicin and epirubicin.
Aukerman, SL; Chello, M; Covino, E; Gonzalez Paz, O; Menna, P; Minotti, G; Salvatorelli, E; Sung, V; Surapaneni, S, 2012
)
0.77
"The regimens in both arms A and B were safe regarding adjuvant chemotherapy for early breast cancer."( Feasibility and toxicity of docetaxel before or after fluorouracil, epirubicin and cyclophosphamide as adjuvant chemotherapy for early breast cancer.
Abe, H; Cho, H; Kawai, Y; Kubota, Y; Kurumi, Y; Mori, T; Tani, T; Umeda, T, 2013
)
0.63
"Low-dose metronomic chemotherapy involves the frequent administration of comparatively low doses of cytotoxic agents with no extended breaks, and it may be as efficient as and less toxic than the conventional maximum tolerated dose therapy."( Efficacy and safety of metronomic chemotherapy for patients with advanced primary hepatocellular carcinoma with major portal vein tumor thrombosis.
Bae, SH; Cha, JH; Choi, BG; Choi, JY; Chun, HJ; Jang, JW; Kim, HL; Woo, HY; Yoon, SK; Youn, JM, 2012
)
0.38
" Adverse events were tolerable and managed successfully with conservative treatment."( Efficacy and safety of metronomic chemotherapy for patients with advanced primary hepatocellular carcinoma with major portal vein tumor thrombosis.
Bae, SH; Cha, JH; Choi, BG; Choi, JY; Chun, HJ; Jang, JW; Kim, HL; Woo, HY; Yoon, SK; Youn, JM, 2012
)
0.38
"Metronomic chemotherapy may be a safe and useful palliative treatment in HCC patients with major PVT."( Efficacy and safety of metronomic chemotherapy for patients with advanced primary hepatocellular carcinoma with major portal vein tumor thrombosis.
Bae, SH; Cha, JH; Choi, BG; Choi, JY; Chun, HJ; Jang, JW; Kim, HL; Woo, HY; Yoon, SK; Youn, JM, 2012
)
0.38
" Primary therapy with concurrent trastuzumab plus paclitaxel-FEC for HER2-positive breast cancer in everyday practice is highly effective and safe confirming the results observed in a randomized trial stopped prematurely."( Efficacy and safety of concurrent trastuzumab plus weekly paclitaxel-FEC as primary therapy for HER2-positive breast cancer in everyday clinical practice.
Climent, F; de Olza, MO; Falo, C; Fernandez-Otega, A; García-Tejedor, A; Germà, JR; Gil-Gil, M; Gumà, A; López-Ojeda, A; Mesia, C; Pérez-Martin, FJ; Pernas, S; Petit, A; Pla, MJ; Urruticoechea, A, 2012
)
0.38
" Adverse events of grade 1/2 were common."( [Docetaxel plus carboplatin versus EC-T as adjuvant chemotherapy for triple-negative breast cancer: safety data from a phase III randomized open-label trial].
Fan, Y; Li, Q; Ma, F; Wang, JY; Wang, WM; Xu, BH; Yuan, P; Zhang, P, 2012
)
0.38
"Both EC-T and TP regimens as adjuvant chemotherapy are safe and tolerable for the treatment of triple-negative breast cancer patients, while the TP regimen has advantages with less grade III/IV alopecia and leukopenia."( [Docetaxel plus carboplatin versus EC-T as adjuvant chemotherapy for triple-negative breast cancer: safety data from a phase III randomized open-label trial].
Fan, Y; Li, Q; Ma, F; Wang, JY; Wang, WM; Xu, BH; Yuan, P; Zhang, P, 2012
)
0.38
" Overall incidence adverse events was not significantly different between the miriplatin plus epirubicin group (50%) and the miriplatin group (49%, p=0."( Initial safety and outcomes of miriplatin plus low-dose epirubicin for transarterial chemoembolisation of hepatocellular carcinoma.
Hashimoto, N; Iwazawa, J; Mitani, T; Ohue, S, 2012
)
0.84
"TACE using miriplatin plus low-dose epirubicin was associated with an increased objective response rate and comparable adverse effects compared to TACE using miriplatin-alone."( Initial safety and outcomes of miriplatin plus low-dose epirubicin for transarterial chemoembolisation of hepatocellular carcinoma.
Hashimoto, N; Iwazawa, J; Mitani, T; Ohue, S, 2012
)
0.9
"To assess the impact of single-nucleotide polymorphisms (SNPs) on predefined severe adverse events in breast cancer (BC) patients receiving (neo-)adjuvant 5-fluorouracil (FU), epirubicin and cyclophosphamide (FEC) chemotherapy."( Genetic variability in the multidrug resistance associated protein-1 (ABCC1/MRP1) predicts hematological toxicity in breast cancer patients receiving (neo-)adjuvant chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide (FEC).
Belmans, A; Brouwers, B; Dieudonné, A; Hatse, S; Lambrechts, D; Neven, P; Paridaens, R; Schöffski, P; van Brussel, T; Vulsteke, C; Wildiers, H, 2013
)
0.77
" Severe adverse events were evaluated through an electronic chart review for febrile neutropenia (FN, primary end point), FN first cycle, prolonged grade 4 or deep (<100/µl) neutropenia, anemia grade 3-4, thrombocytopenia grade 3-4 and non-hematological grade 3-4 events (secondary end points)."( Genetic variability in the multidrug resistance associated protein-1 (ABCC1/MRP1) predicts hematological toxicity in breast cancer patients receiving (neo-)adjuvant chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide (FEC).
Belmans, A; Brouwers, B; Dieudonné, A; Hatse, S; Lambrechts, D; Neven, P; Paridaens, R; Schöffski, P; van Brussel, T; Vulsteke, C; Wildiers, H, 2013
)
0.58
" Adverse events of grade 3 or higher occurred in 3 patients (11."( [Efficacy and safety of maintenance intravesical instillation therapy with bacillus Calmette-Guerin and epirubicin for non-muscle invasive bladder cancer].
Fujii, Y; Hosoda, C; Ikeda, M; Kamigaito, T; Komatsu, H; Kurosawa, K; Miyakawa, J; Motoshima, T; Okaneya, T, 2013
)
0.6
" Diarrhea was the most common adverse event."( Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA).
Chia, S; Cortés, J; Eniu, A; Harvey, V; Hegg, R; Hickish, T; McNally, V; Ratnayake, J; Ross, G; Schneeweiss, A; Seo, JH; Tausch, C; Tsai, YF, 2013
)
0.39
" Observed adverse drug reactions with an incidence of > 5% were back pain (60."( The efficacy and safety of FSK0808, filgrastim biosimilar: a multicenter, non-randomized study in Japanese patients with breast cancer.
Fukuma, E; Higaki, K; Masuda, N; Mizutani, M; Ohno, S; Osaki, A; Saeki, T; Sagara, Y; Sato, K; Suzuki, M; Takano, T; Tokuda, Y, 2013
)
0.39
"FSK0808 was safe and well tolerated in breast cancer patients undergoing chemotherapy and effectively stimulated neutrophil recovery."( The efficacy and safety of FSK0808, filgrastim biosimilar: a multicenter, non-randomized study in Japanese patients with breast cancer.
Fukuma, E; Higaki, K; Masuda, N; Mizutani, M; Ohno, S; Osaki, A; Saeki, T; Sagara, Y; Sato, K; Suzuki, M; Takano, T; Tokuda, Y, 2013
)
0.39
" However, a critical issue associated with trastuzumab treatment is its cardiotoxic adverse effects, including cardiac insufficiency."( High-sensitivity cardiac troponin I detection for 2 types of drug-induced cardiotoxicity in patients with breast cancer.
Kawahara, E; Mokuyasu, S; Seto, T; Suzuki, Y; Tokuda, Y, 2015
)
0.42
" Source data verification of adverse events was performed by two independent observers."( Safety, efficacy, and long-term follow-up evaluation of perioperative epirubicin, Cisplatin, and capecitabine chemotherapy in esophageal resection for adenocarcinoma.
Boonstra, JJ; Borel Rinkes, IH; Lolkema, MP; Los, M; Ruurda, JP; Schipper, ME; Siersema, PD; Ubink, I; van der Horst, S; van der Sluis, PC; van Hillegersberg, R; Voest, EE; Wiezer, MJ, 2015
)
0.65
" Grades 3 and 4 nonhematologic adverse events of preoperative chemotherapy mainly consisted of thromboembolic events (16."( Safety, efficacy, and long-term follow-up evaluation of perioperative epirubicin, Cisplatin, and capecitabine chemotherapy in esophageal resection for adenocarcinoma.
Boonstra, JJ; Borel Rinkes, IH; Lolkema, MP; Los, M; Ruurda, JP; Schipper, ME; Siersema, PD; Ubink, I; van der Horst, S; van der Sluis, PC; van Hillegersberg, R; Voest, EE; Wiezer, MJ, 2015
)
0.65
"For patients with adenocarcinoma of the esophagus or GEJ, six cycles of ECC-based perioperative chemotherapy is associated with a relatively high number of adverse events."( Safety, efficacy, and long-term follow-up evaluation of perioperative epirubicin, Cisplatin, and capecitabine chemotherapy in esophageal resection for adenocarcinoma.
Boonstra, JJ; Borel Rinkes, IH; Lolkema, MP; Los, M; Ruurda, JP; Schipper, ME; Siersema, PD; Ubink, I; van der Horst, S; van der Sluis, PC; van Hillegersberg, R; Voest, EE; Wiezer, MJ, 2015
)
0.65
"7% of patients experienced grade 3 and 4 adverse events, respectively."( Feasibility and cardiac safety of trastuzumab emtansine after anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer.
Campone, M; Citron, ML; Dang, CT; Dirix, L; Gianni, L; Krop, IE; Romieu, G; Smitt, M; Suter, TM; Xu, N; Zamagni, C, 2015
)
0.42
" There were no incidences of anaphylaxis or Grade 4/5 adverse events."( Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety.
Hasebe, T; Hirokawa, E; Kuji, I; Matsuura, K; Osaki, A; Saeki, T; Shigekawa, T; Shimada, H; Sugitani, I; Sugiyama, M; Takahashi, T; Takeuchi, H; Ueda, S; Yamane, T, 2015
)
0.65
"Anthracycline-induced cardiotoxicity (ACT) is a well-known serious adverse drug reaction leading to substantial morbidity."( Clinical and genetic risk factors for epirubicin-induced cardiac toxicity in early breast cancer patients.
Dieudonné, AS; Hatse, S; Lambrechts, D; Maggen, C; Neven, P; Paridaens, R; Pettengell, R; Pfeil, AM; Schwenkglenks, M; Szucs, TD; Vulsteke, C; Wildiers, H, 2015
)
0.69
" There was no statistically significant difference in the rates of grade 3-4 adverse events (EOX 79."( Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma: a randomized phase 3 trial.
Budzynski, A; Fijorek, K; Konopka, K; Krzemieniecki, K; Lazar, A; Matlok, M; Ochenduszko, S; Pedziwiatr, M; Puskulluoglu, M; Sinczak-Kuta, A; Urbanczyk, K, 2015
)
0.42
" Surgery was carried out three weeks after the end of chemotherapy, and the chemotherapy efficacy and adverse reaction of both groups were evaluated."( [Efficacy and safety analysis of paclitaxel liposome and docetaxel for the neoadjuvant chemotherapy of breast cancer].
Hao, X; Li, C; Su, W; Zhang, J; Zhang, S, 2015
)
0.42
" Safety analysis indicated that all the occurrence rates of skin and nail toxic reaction, body fluid retention, oral mucositis, allergic reaction (such as facial blushing, chest distress, palpitation, dyspnea."( [Efficacy and safety analysis of paclitaxel liposome and docetaxel for the neoadjuvant chemotherapy of breast cancer].
Hao, X; Li, C; Su, W; Zhang, J; Zhang, S, 2015
)
0.42
"Compared with docetaxel, paclitaxel liposome has the same anti-tumor efficacy, but causes fewer and milder adverse reactions with a higher safety in the neoadjuvant chemotherapy for breast cancer."( [Efficacy and safety analysis of paclitaxel liposome and docetaxel for the neoadjuvant chemotherapy of breast cancer].
Hao, X; Li, C; Su, W; Zhang, J; Zhang, S, 2015
)
0.42
"Epirubicin is widely used for the treatment of various breast cancers; however, it has serious adverse side effects, such as hepatotoxicity, which require dose-adjustment or therapy substitution."( The protective effects of paeonol against epirubicin-induced hepatotoxicity in 4T1-tumor bearing mice via inhibition of the PI3K/Akt/NF-kB pathway.
Cao, H; Guo, R; Jiang, W; Sun, D; Wang, R; Wu, J; Xue, X; Zhang, B, 2016
)
2.14
" Furthermore, the relationship between such adverse events and quality of life (QOL) was evaluated."( Comparison of Doctors' and Breast Cancer Patients' Perceptions of Docetaxel, Epirubicin, and Cyclophosphamide (TEC) Toxicity.
Bayo, J; Prieto, B; Rivera, F, 2016
)
0.66
" Adverse events (AEs) were recorded and analyzed."( Safety Analysis of Adjuvant Chemotherapy with Docetaxel Administered with or without Anthracyclines to Early Stage Breast Cancer Patients: Combined Results from the Asia- Pacific Breast Initiatives I and II.
Ba, DN; Chao, TY; Hou, MF; Kim, SB; Sayeed, A; Shah, MA; Shen, ZZ; Thuan, TV; Villalon, AH; Yau, TK, 2016
)
0.43
" Adverse events were reported in 86% of patients (anthracycline-containing regimens vs."( Safety Analysis of Adjuvant Chemotherapy with Docetaxel Administered with or without Anthracyclines to Early Stage Breast Cancer Patients: Combined Results from the Asia- Pacific Breast Initiatives I and II.
Ba, DN; Chao, TY; Hou, MF; Kim, SB; Sayeed, A; Shah, MA; Shen, ZZ; Thuan, TV; Villalon, AH; Yau, TK, 2016
)
0.43
" No unusual adverse events linked to Asia-Pacific region patients were observed."( Safety Analysis of Adjuvant Chemotherapy with Docetaxel Administered with or without Anthracyclines to Early Stage Breast Cancer Patients: Combined Results from the Asia- Pacific Breast Initiatives I and II.
Ba, DN; Chao, TY; Hou, MF; Kim, SB; Sayeed, A; Shah, MA; Shen, ZZ; Thuan, TV; Villalon, AH; Yau, TK, 2016
)
0.43
" However, anthracycline-induced cardiotoxicity (AIC) is a serious adverse drug reaction that affects the survival in patients treated for childhood cancer."( [Anthracycline-induced cardiotoxicity: report of fatal cases].
Betanzos-Cabrera, Y; Castelán-Martínez, OD; de Jesús Estrada-Loza, M; Rivas-Ruiz, R; Vargas-Neri, JL,
)
0.13
"Cardiotoxicity remains an important adverse reaction of chemotherapy used in the treatment of breast cancer, leading to increased morbidity and mortality."( Mechanisms and Genetic Susceptibility of Chemotherapy-Induced Cardiotoxicity in Patients With Breast Cancer.
Florescu, M; Mihalcea, DJ; Vinereanu, D,
)
0.13
" However, it has serious adverse side effects, particularly cardiotoxicity, which can cause irreversible damage in patients."( Enhanced antitumor activity and attenuated cardiotoxicity of Epirubicin combined with Paeonol against breast cancer.
Cao, H; Guo, R; Jiang, W; Kong, F; Li, J; Sun, D; Wu, J; Xue, X; Zhang, B, 2016
)
0.68
" This single-center prospective study demonstrated that the dose-modified IVE regimen can be used as a safe treatment with high mobilizing efficacy in heavily pretreated lymphoma patients."( Dose-Modified Ifosfamide, Epirubicin, and Etoposide is a Safe and Effective Salvage Therapy with High Peripheral Blood Stem Cell Mobilization Capacity for Poorly Mobilized Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma Patients.
Arima, N; Fukunaga, A; Hyuga, M; Iwasaki, M; Kishimoto, W; Maesako, Y; Nakae, Y, 2016
)
0.73
" Response rates, overall survival, progression-free survival, and adverse effects were retrospectively analyzed."( [A cohort study comparing the efficacy and safety of bortezomib plus dexamethasone versus bortezomib, epirubicin and dexamethasone in patients with multiple myeloma].
Chen, H; Hao, QY; Huang, XJ; Liu, KY; Lu, J; Wen, L, 2016
)
0.65
" (4) Grade 3 and 4 adverse events were recorded with a higher number of patients in the PAD group than those in the BD group."( [A cohort study comparing the efficacy and safety of bortezomib plus dexamethasone versus bortezomib, epirubicin and dexamethasone in patients with multiple myeloma].
Chen, H; Hao, QY; Huang, XJ; Liu, KY; Lu, J; Wen, L, 2016
)
0.65
" Cardiotoxicity is the most severe side effect of anthracycline administration."( [Cardiooncology: Current Aspects of Prevention of Anthracycline Toxicity].
Nesterov, VV; Shkolnik, EL; Shkolnik, LD; Varlan, GV; Vasyuk, YA, 2016
)
0.43
" TEM showed the relatively uniform spherical structure for particles and in vitro MTT assay showed that EPI loaded micelles were more toxic on Hela cell line than MCF7 as expected."( Folic acid Targeted Polymeric Micelles Based on Tocopherol Succinate- Pulluan as an Effective Carrier for Epirubicin: Preparation, Characterization and In-vitro Cytotoxicity Assessment.
Hassanzadeh, F; Khodarahmi, GA; Mehdifar, M; Rostami, M; Varshosaz, J, 2018
)
0.69
"The TCH protocol is an efficacious neoadjuvant chemotherapy regimen for locally advanced and oligometastatic breast cancer and is safe and well tolerated in this population."( Retrospective study of efficacy and safety of neoadjuvant docetaxel, carboplatin, and trastuzumab in HER2-positive locally advanced and oligometastatic breast cancer: An Indian experience.
Deo, S; Gogia, A; Mathur, S; Sharma, DN; Shukla, NK; Tiwari, A,
)
0.13
"2% of patients experienced one or more adverse event, 10."( Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2-Positive Early
Ahn, JH; Bello, M; Bondarenko, I; Chatterjee, S; Dvorkin, M; Im, SA; Lim, J; Moiseyenko, V; Nowecki, Z; Pivot, X; Sarosiek, T; Semiglazov, V; Shparyk, Y; Song, S; Trishkina, E; Vinnyk, Y; Wojtukiewicz, MZ, 2018
)
0.48
" In the period of 30 days after treatment we found no grade 5 adverse events (AE)."( Efficacy and Safety of Drug Eluting Bead TACE with Microspheres <150 μm for the Treatment of Hepatocellular Carcinoma.
Bredt, C; Jakobs, T; Rieger, J; Rust, C; Sattler, T; Surwald, S, 2018
)
0.48
" The incidence of treatment-emergent adverse events was comparable between groups (SB3, 97."( A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results.
Ahn, JH; Bello, M; Bondarenko, I; Chatterjee, S; Dvorkin, M; Im, SA; Lee, Y; Lim, J; Moiseyenko, V; Nowecki, Z; Pivot, X; Sarosiek, T; Semiglazov, V; Shparyk, Y; Trishkina, E; Wojtukiewicz, MZ, 2018
)
0.48
" Common Terminology Criteria for Adverse Events (CTCAE) was used to assess the adverse events and liver dysfunction during and after the operation."( Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients.
Chen, LM; Chen, SQ; Han, J; Nie, CH; Sun, JH; Wang, BQ; Wang, HL; Wang, WL; Yu, ZN; Zhang, YL; Zheng, SS; Zhou, GH; Zhou, TY; Zhu, TY, 2018
)
0.48
" Besides, most of the common adverse events were light and moderate in our study."( Efficacy and safety profile of drug-eluting beads transarterial chemoembolization by CalliSpheres® beads in Chinese hepatocellular carcinoma patients.
Chen, LM; Chen, SQ; Han, J; Nie, CH; Sun, JH; Wang, BQ; Wang, HL; Wang, WL; Yu, ZN; Zhang, YL; Zheng, SS; Zhou, GH; Zhou, TY; Zhu, TY, 2018
)
0.48
" Laboratory assessment pre/post-procedural and complications were analysed, respectively, according to Common Terminology Criteria for Adverse Events (CTCAEv5) and CIRSE system."( Balloon-Occluded Transcatheter Arterial Chemoembolization (b-TACE) for Hepatocellular Carcinoma Performed with Polyethylene-Glycol Epirubicin-Loaded Drug-Eluting Embolics: Safety and Preliminary Results.
Basilico, F; Bezzi, M; Cannavale, A; Catalano, C; Corona, M; De Rubeis, G; Ginnani Corradini, L; Lucatelli, P; Nardis, PG; Rocco, B; Saba, L, 2019
)
0.72
" 4/24 adverse events occurred (17%): pseudo-aneurysm of the feeder (grade 3), liver abscess (grade 2) and 2 asymptomatic segmentary biliary tree dilatations (grade 2)."( Balloon-Occluded Transcatheter Arterial Chemoembolization (b-TACE) for Hepatocellular Carcinoma Performed with Polyethylene-Glycol Epirubicin-Loaded Drug-Eluting Embolics: Safety and Preliminary Results.
Basilico, F; Bezzi, M; Cannavale, A; Catalano, C; Corona, M; De Rubeis, G; Ginnani Corradini, L; Lucatelli, P; Nardis, PG; Rocco, B; Saba, L, 2019
)
0.72
"Epirubicin-loaded PEG microsphere b-TACE is technically feasible, safe and effective procedure for HCC treatment."( Balloon-Occluded Transcatheter Arterial Chemoembolization (b-TACE) for Hepatocellular Carcinoma Performed with Polyethylene-Glycol Epirubicin-Loaded Drug-Eluting Embolics: Safety and Preliminary Results.
Basilico, F; Bezzi, M; Cannavale, A; Catalano, C; Corona, M; De Rubeis, G; Ginnani Corradini, L; Lucatelli, P; Nardis, PG; Rocco, B; Saba, L, 2019
)
2.16
" Clinical response, pathological complete response (pCR), and adverse events were evaluated."( [Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel as Neoadjuvant Chemotherapy in Breast Cancer Patients].
Kang, Y; Shiraki, E; Tsuyuki, S, 2019
)
0.51
"nab-PTX±trastuzumab followed by FEC as NAC is effective and safe for operative breast cancer, especially HER2-type breast cancer."( [Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel as Neoadjuvant Chemotherapy in Breast Cancer Patients].
Kang, Y; Shiraki, E; Tsuyuki, S, 2019
)
0.51
" Liver function and adverse events (AEs) were assessed before and after DEB-TACE operation."( Efficacy and Safety of Drug-Eluting Beads Transarterial Chemoembolization by CalliSpheres
Cao, G; Chen, Y; Du, H; Fang, J; Gu, W; Guo, X; Han, J; Hou, Q; Hu, H; Hu, T; Hu, W; Huang, J; Ji, J; Ji, W; Li, L; Li, T; Luo, J; Peng, Z; Shao, G; Shi, C; Sun, J; Sun, Z; Wu, X; Xie, X; Xu, H; Ying, S; Yu, W; Yu, Z; Zhang, X; Zheng, J; Zhou, G; Zhou, J; Zhu, D, 2020
)
0.56
" Apart from one possibly procedure-related grade 3 complication, only grade 1 adverse events occurred."( Transarterial Chemoembolisation (TACE) with Degradable Starch Microspheres (DSM) and Anthracycline in Patients with Locally Extensive Hepatocellular Carcinoma (HCC): Safety and Efficacy.
Albrecht, T; Gross, A, 2020
)
0.56
"DSM-TACE of HCC is safe even in patients with advanced disease stages."( Transarterial Chemoembolisation (TACE) with Degradable Starch Microspheres (DSM) and Anthracycline in Patients with Locally Extensive Hepatocellular Carcinoma (HCC): Safety and Efficacy.
Albrecht, T; Gross, A, 2020
)
0.56
" Progression-free survival (PFS) and overall survival (OS) were evaluated, and adverse events (AEs) as well as liver function-related laboratory indexes of all DEB-TACE records (N=131) were assessed."( Retrospective analysis of efficacy, safety, and prognostic factors in a cohort of Chinese hepatocellular carcinoma patients treated with drug-eluting bead transarterial chemoembolization.
Chen, S; Ji, R; Shi, X; Wang, Z; Zhu, D, 2019
)
0.51
"High-dose anlotinib combined with epirubicin was an effective and safe therapy for STS."( Efficacy and safety of anlotinib, a multikinase angiogenesis inhibitor, in combination with epirubicin in preclinical models of soft tissue sarcoma.
Guo, X; Lu, WQ; Tong, HX; Wang, ZM; Yang, H; Zhang, SL; Zhang, Y; Zhou, YH; Zhuang, RY, 2020
)
1.06
" In order to gain insight on its toxic effects, intact red blood cells (RBC), human erythrocyte membranes and molecular models were used."( Toxic effects of the anticancer drug epirubicin in vitro assayed in human erythrocytes.
Aguilar, LF; Colina, JR; Contreras, D; Jemiola-Rzeminska, M; Petit, K; Strzalka, K; Suwalsky, M, 2020
)
0.83
"Chemotherapy-induced alopecia (CIA) represents the most distressing side-effect for cancer patients."( Cooling-mediated protection from chemotherapy drug-induced cytotoxicity in human keratinocytes by inhibition of cellular drug uptake.
Collett, A; Dunnill, C; Georgopoulos, NT; Ibraheem, K; Ioannou, M; Palmer, M; Peake, M; Smith, A, 2020
)
0.56
"TACE using a GMD is effective and safe in clinical practice."( Safety and Efficacy of Glass Membrane Pumping Emulsification Device in Transarterial Chemoembolization for Hepatocellular Carcinoma: First Clinical Outcomes.
Honda, T; Imai, N; Ishigami, M; Ishizu, Y; Ito, T; Yamamoto, K; Yokoyama, S, 2021
)
0.62
" However, a previous study reported on the development of adverse events, such as neutropenia, in Asian patients."( [Comparison of Adverse Events during EC or TC Therapy for Breast Cancer at the Kakogawa Central City Hospital].
Ogino, M; Sakoda, Y; Suzuki, H; Tsuchiya, K, 2021
)
0.62
" The primary endpoint was objective response rates (ORR), and secondary endpoints were duration of response and incidence of adverse events (AEs)."( The Short-Term Efficacy and Safety of Brentuximab Vedotin Plus Cyclophosphamide, Epirubicin and Prednisone in Untreated PTCL: A Real-World, Retrospective Study.
Bai, O; Feng, X; Guo, Q; Guo, W; Li, J; Qu, L; Wang, Y; Yan, X; Young, KH; Zhao, Y, 2022
)
0.95
" Adverse events (AEs), including incidence and severity of febrile neutropenia (26% patients in the BV-CEP group and 30% in the CHOEP group), were similar between groups."( The Short-Term Efficacy and Safety of Brentuximab Vedotin Plus Cyclophosphamide, Epirubicin and Prednisone in Untreated PTCL: A Real-World, Retrospective Study.
Bai, O; Feng, X; Guo, Q; Guo, W; Li, J; Qu, L; Wang, Y; Yan, X; Young, KH; Zhao, Y, 2022
)
0.95
" The secondary outcome was adverse reactions."( Effectiveness and safety of pegylated liposomal doxorubicin versus epirubicin as neoadjuvant or adjuvant chemotherapy for breast cancer: a real-world study.
Bao, G; Jiang, H; Wang, H; Wang, X; Zhang, G; Zhang, J, 2021
)
0.86
" Lobaplatin-TACE is a safe and effective treatment strategy; it is worthy of clinical application."( Efficacy and Safety of Lobaplatin-TACE in the Treatment of Primary Hepatocellular Carcinoma: A Retrospective Study.
Liang, B; Lu, H; Xiong, B; Zheng, C, 2023
)
0.91
" Studying epigenetic modification such as DNA methylation can help to understand the EPI-related toxic mechanisms in cardiac tissue."( Epirubicin Alters DNA Methylation Profiles Related to Cardiotoxicity.
Herwig, R; Jennen, D; Kleinjans, J; Lienhard, M; Nguyen, N, 2022
)
2.16
"Human cardiac microtissues were exposed to either therapeutic or toxic (IC20) EPI doses during 2 weeks."( Epirubicin Alters DNA Methylation Profiles Related to Cardiotoxicity.
Herwig, R; Jennen, D; Kleinjans, J; Lienhard, M; Nguyen, N, 2022
)
2.16
"After processing the MeDIP-seq data, we detected 35, 37, 15 candidate genes which show strong methylated alterations between all EPI-treated, EPI therapeutic and EPI toxic dose-treated samples compared to control, respectively."( Epirubicin Alters DNA Methylation Profiles Related to Cardiotoxicity.
Herwig, R; Jennen, D; Kleinjans, J; Lienhard, M; Nguyen, N, 2022
)
2.16
"Cardiotoxicity is the major side effect of anthracyclines (doxorubicin, daunorubicin, epirubicin, and idarubicin), though being the most commonly used chemotherapy drugs and the mainstay of therapy in solid and hematological neoplasms."( The Role of Mitochondrial Quality Control in Anthracycline-Induced Cardiotoxicity: From Bench to Bedside.
Bai, R; Chang, X; Li, L; Li, Y; Lin, R; Liu, N; Liu, X; Peng, X; Ruan, Y; Tang, R; Wang, X; Wen, S, 2022
)
0.94
" The most common grade 3-4 adverse events were myalgia (14."( Efficacy and safety of dose-dense neoadjuvant chemotherapy with nab-paclitaxel followed by epirubicin and cyclophosphamide for operable breast cancer.
Ikeda, T; Isono, Y; Jinno, H; Maeda, Y; Matsumoto, A; Naruse, S; Sasajima, Y; Sato, A; Yamada, M, 2023
)
1.13

Pharmacokinetics

The aim of the study was to assess the pharmacokinetic linearity of epirubicin given at high doses. The association is feasible, with low cardiotoxicity, and has a high activity in metastatic breast cancer.

ExcerptReferenceRelevance
" There was no correlation between this pharmacokinetic parameter and degree of obesity."( Epirubicin as a single agent therapy for the treatment of breast cancer--a pharmacokinetic and clinical study.
Bengtsson, NO; Eksborg, S; Elfsson, B; Hardell, L; Sjödin, M, 1992
)
1.73
" Pharmacokinetic parameters such as total plasma clearance, total volume of distribution, mean residence time and elimination half-life were similar, irrespective of the duration of the administration."( Pharmacokinetics and metabolism of epirubicin administered as i.v. bolus and 48-h infusion in patients with advanced soft-tissue sarcoma.
Bui, NB; Robert, J, 1992
)
0.56
"The study reports pharmacokinetic findings on the disposition of a formulated emulsion of epirubicin in rabbits as compared to plain epirubicin solution after intrahepato-arterial and intravenous administration."( Pharmacokinetics of epirubicin emulsion and solution in rabbits after intrahepato-arterial and intravenous injection.
Chan, K; Lee, K, 1992
)
0.83
"Population pharmacokinetic analysis of the anticancer agent epirubicin was carried out using the program NONMEM."( Variability in the pharmacokinetics of epirubicin: a population analysis.
Kelman, AW; Kerr, DJ; Robert, J; Wade, JR; Whiting, B, 1992
)
0.8
" In contrast, when administered in the S-EPI formulation, the distribution half-life of the drug was over 22 hr."( Pharmacokinetics and antitumor activity of epirubicin encapsulated in long-circulating liposomes incorporating a polyethylene glycol-derivatized phospholipid.
Babbar, S; Lasic, D; Martin, FJ; Mayhew, EG, 1992
)
0.55
" The rabbit seemed to be an interesting animal species for pharmacokinetic studies because of easy blood sampling, detection of small amounts of glucuronides and because of a good fit to tri-exponential kinetics model."( Pharmacokinetics of epirubicin after intravenous administration: experimental and clinical aspects.
Brunet, C; Cazin, M; Dine, T; Luyckx, M, 1991
)
0.6
" In most cases (76 of 78 cases), plasma concentration-time curves fitted to a three-compartmental pharmacokinetic model."( Multiple-dose pharmacokinetics of epirubicin at four different dose levels: studies in patients with metastatic breast cancer.
Bastholt, L; Dalmark, M; Gjedde, SB; Jakobsen, P; Lorenzen, A; Nielsen, OS; Petersen, D; Rose, C; Sandberg, E; Steiness, E, 1991
)
0.56
" The terminal half-life from 24 to 72 h was not significantly changed by the partial hepatectomy."( The influence of partial hepatectomy on the pharmacokinetics of preoperatively injected 4'-epidoxorubicin in rats.
Endresen, L; Hall, KS; Rugstad, HE; Schjerven, L, 1990
)
0.28
"In pharmacokinetic studies of epirubicin, we observed that its main metabolite, epirubicin glucuronide, presented a marked interpatient variation."( Metabolism of epirubicin to glucuronides: relationship to the pharmacodynamics of the drug.
David, M; Granger, C; Robert, J, 1990
)
0.93
" To find a pharmacokinetic basis for the observed difference in cardiotoxicity between the drugs, concentrations of doxorubicin, epidoxorubicin and all known metabolites were measured in the plasma, heart and tumor tissue of BALB/c mice bearing colon-26 tumors."( Comparative metabolism and pharmacokinetics of doxorubicin and 4'-epidoxorubicin in plasma, heart and tumor of tumor-bearing mice.
Maessen, PA; Pinedo, HM; van der Vijgh, WJ, 1990
)
0.28
" Administration of the 150 mg/m2 dose over the 6 h compared to the bolus administration was associated with a 92% decrease in peak concentration from 3088 +/- 1503 to 234 +/- 126 ng/ml."( Pharmacokinetics and toxicity of two schedules of high dose epirubicin.
Doig, RG; Green, MD; Mihaly, G; Morstyn, G; Sheridan, WP; Sobol, MM; Tjuljandin, SA; Watson, DM, 1990
)
0.52
" Pharmacokinetic data indicated myocardial extraction, followed by myocardial release of both drugs."( Pharmacokinetics and central haemodynamic effects of doxorubicin and 4'epi-doxorubicin in the pig.
Andersson, M; Domellöf, L; Eksborg, S; Häggmark, S; Herslöf, A; Johansson, G; Reiz, S, 1989
)
0.28
" The area under the plasma concentration-time curve (AUC), the maximum plasma concentration (Cmax), mean residence time (MRT) and the terminal half-life time (t1/2) could differ by more than 35% after morning and afternoon dosing."( Pharmacokinetics of 4' epi-adriamycin after morning and afternoon intravenous administration.
Antila, K; Eksborg, S; Stendahl, U, 1989
)
0.28
" Terminal half-life and volume of distribution appeared to be smaller in case of EPI, whereas plasma clearance and cumulative urinary excretion was larger in comparison to DOX."( Pharmacokinetics and metabolism of epidoxorubicin and doxorubicin in humans.
Boven, E; Gall, H; Maessen, P; Mross, K; Pinedo, HM; van der Vijgh, WJ, 1988
)
0.27
" Each molecule is characterized by original metabolic and pharmacokinetic features, which can be compared to those of the reference anthracyclines, doxorubicin and daunorubicin."( [Pharmacokinetics of new anthracyclines].
Robert, J, 1988
)
0.27
" These types of pharmacokinetic behavior of epirubicin appeared to be similar to those of doxorubicin."( [Pharmacokinetics of epirubicin in cancer patients].
Kimura, K; Ohno, T; Shimoyama, T; Yamada, H, 1986
)
0.85
" In serum, a rapid initial distribution phase, with a half-life of about 5 minutes for DOX and 4 minutes for epi-DOX, was followed by a slower decrease in the drug levels."( Comparative pharmacokinetics of doxorubicin and epirubicin in patients with gastrointestinal cancer.
Gunvén, P; Peterson, C; Theve, NO, 1986
)
0.53
" The plasma concentrations of each drug followed a three-compartment open model, with great interindividual variation in the pharmacokinetic parameters."( Comparative pharmacokinetic study of adriamycin and 4'epi-adriamycin after their simultaneous intravenous administration.
Eksborg, S; Lönroth, U; Stendahl, U, 1986
)
0.27
" Pharmacokinetic studies were performed by high-performance liquid chromatography (HPLC) with fluorometric detection."( A phase I and pharmacokinetic study with 21-day continuous infusion of epirubicin.
de Vries, EG; Greidanus, J; Mulder, NH; Nieweg, MB; Postmus, PE; Schipper, DL; Sleijfer, DT; Uges, DR; Willemse, PH, 1987
)
0.51
" The pharmacokinetic parameters of epirubicin were characterized by a high total plasma clearance (mean value: 70-85 1/hr) and a mean elimination half-life of 25-35 hr."( Pharmacokinetics and metabolism of epirubicin during repetitive courses of administration in Hodgkin's patients.
Eghbali, H; Hoerni, B; Iliadis, A; Robert, J; Vrignaud, P, 1985
)
0.82
" Blood clearance is lower than plasma clearance; volume of distribution at steady state Vss is lower if blood concentration data are used in the pharmacokinetic analysis."( Epirubicin plasma and blood pharmacokinetics after single i.v. bolus in advanced cancer patients.
Angelelli, B; Camaggi, CM; Comparsi, R; Martoni, A; Pannuti, F; Strocchi, E, 1985
)
1.71
" The differences in the pharmacokinetic and metabolic properties of the two drugs may be responsible for the differences in toxicity that have been noticed between them in previous phase I and II studies."( Comparative pharmacokinetics and metabolism of doxorubicin and epirubicin in patients with metastatic breast cancer.
Hurteloup, P; Iliadis, A; Mauriac, L; Nguyen-Ngoc, T; Robert, J; Vrignaud, P, 1985
)
0.51
" 4'-epi-DX gave plasma levels constantly lower than those observed after DX; the pharmacokinetic study showed that 4'-epi-DX was eliminated from the body more rapidly (t1/2 30 hours as compared with 43 hours)."( Cross-over study of pharmacokinetics and haematological toxicity of 4'-epi-doxorubicin and doxorubicin in cancer patients.
Martini, A; Moro, E; Natale, N; Pacciarini, MA; Piazza, E; Tamassia, V, 1984
)
0.27
" QUI possesses a statistical significant influence on the EPR serum concentrations and, as a consequence, on the pharmacokinetic parameters for the initial distribution phase of EPR."( Pharmacokinetic interaction between 4'-epidoxorubicin and the multidrug resistance reverting agent quinine.
Bandak, S; Czejka, M; Schernhammer, E; Schüller, J; Simon, D; Weiss, C,
)
0.13
" A statistical significant influence in regard to the terminal elimination half-life (gamma-HL) and the total clearance (CLtot) was found, indicating a reduction of gamma-HL from 18."( Pharmacokinetic drug interaction between epirubicin and interferon-alpha-2b in serum and red blood cells.
Bandak, S; Czejka, M; Schernhammer, E; Schüller, J, 1995
)
0.56
" Dose and duration of infusion of a drug may govern its activity; the drugs exhibiting a short half-life in plasma and a marked phase-dependence in their mechanism of action have to be administered as continuous infusions."( [Pharmacokinetic mechanisms of resistance to anticancer medications].
Robert, J, 1994
)
0.29
" Studies are need to determine the optimal dose ratio for cardioprotection and to explore further the pharmacokinetic interactions of the two drugs at increasing doses of epirubicin supported by hematopoietic growth factors."( Comparative study of the pharmacokinetics and toxicity of high-dose epirubicin with or without dexrazoxane in patients with advanced malignancy.
Basser, RL; Cebon, J; Duggan, G; Green, MD; Mihaly, G; Rosenthal, MA; Sobol, MM, 1994
)
0.72
"The potential for a pharmacokinetic interaction between epirubicin and the second-generation multidrug resistance modulating agent D-verapamil (DVPM) has been investigated in six patients with advanced colorectal cancer."( Pharmacokinetic interaction between epirubicin and the multidrug resistance reverting agent D-verapamil.
Czejka, M; Scheithauer, W; Schenk, T, 1993
)
0.81
" Both groups were studied according to a balanced cross-over design; the aim of the study was to assess the pharmacokinetic linearity of epirubicin given at high doses."( Epirubicin metabolism and pharmacokinetics after conventional- and high-dose intravenous administration: a cross-over study.
Camaggi, CM; Carisi, P; Martoni, A; Melotti, B; Pannuti, F; Strocchi, E, 1993
)
1.93
" We studied the pharmacokinetics and metabolism of both epirubicin (EPI) and verapamil (VPL) to explore the possible pharmacokinetic interactions between these two drugs."( Effects of verapamil on the pharmacokinetics and metabolism of epirubicin.
Hamm, K; Hossfeld, DK; Mross, K, 1993
)
0.77
"Our study demonstrates that (1) the MTD is epirubicin 90 mg/m2 and paclitaxel 200 mg/m2; (2) no clear relationship exists between pharmacokinetic data of paclitaxel and myelosuppression, while the increase in the dose of paclitaxel is associated with a reduction in epirubicinol plasma levels; and (3) the association is feasible, with low cardiotoxicity, and has a high activity in metastatic breast cancer."( Dose-finding study and pharmacokinetics of epirubicin and paclitaxel over 3 hours: a regimen with high activity and low cardiotoxicity in advanced breast cancer.
Baldini, E; Biadi, O; Conte, PF; Danesi, R; Del Tacca, M; Dell'Anna, R; Gennari, A; Gentile, A; Innocenti, F; Mariani, M; Michelotti, A; Salvadori, B; Tibaldi, C, 1997
)
0.82
" Pharmacokinetic data from women being treated with combination therapy for advanced breast cancer demonstrate that the administration of docetaxel following doxorubicin does not alter doxorubicin's area under the plasma concentration-time, curve, maximum plasma concentration, or time until maximum plasma concentration is reached."( Taxoids in combination with anthracyclines and other agents: pharmacokinetic considerations.
Colombo, T; D'Incalci, M; Riva, A; Schüller, J; Zucchetti, M, 1998
)
0.3
"The aim of the present study was to investigate possible pharmacokinetic interactions between epirubicin (EPI) and docetaxel (DTX) in rats."( The pharmacokinetics of epirubicin and docetaxel in combination in rats.
Freijs, A; Karlsson, MO; Sandström, M; Simonsen, LE, 1999
)
0.83
" Pharmacokinetic evaluation was carried out using the NONMEM program."( The pharmacokinetics of epirubicin and docetaxel in combination in rats.
Freijs, A; Karlsson, MO; Sandström, M; Simonsen, LE, 1999
)
0.61
"No pharmacokinetic interaction between the parent compound epirubicin and taxanes was detected."( Comparative effects of paclitaxel and docetaxel on the metabolism and pharmacokinetics of epirubicin in breast cancer patients.
Angiolini, C; Bergaglio, M; Del Mastro, L; Esposito, M; Garrone, O; Lunardi, G; Rosso, R; Tolino, G; Vannozzi, MO; Venturini, M; Viale, M, 1999
)
0.77
"There is no apparent pharmacokinetic interaction between the parent compound epirubicin and paclitaxel or docetaxel."( Comparative effects of paclitaxel and docetaxel on the metabolism and pharmacokinetics of epirubicin in breast cancer patients.
Angiolini, C; Bergaglio, M; Del Mastro, L; Esposito, M; Garrone, O; Lunardi, G; Rosso, R; Tolino, G; Vannozzi, MO; Venturini, M; Viale, M, 1999
)
0.75
" The pharmacokinetic differences of the two drugs were established by their simultaneous administration."( A comparative pharmacokinetic study of doxorubicin and 4'-epi-doxorubicin in children with acute lymphocytic leukemia using a limited sampling procedure.
Björk, O; Eksborg, S; Palm, C, 2000
)
0.31
" Haematological parameters were monitored and two to four samples per animal were drawn to determine the pharmacokinetic parameters in NONMEM."( Determination of drug effect on tumour cells, host animal toxicity and drug pharmacokinetics in a hollow-fibre model in rats.
Freijs, A; Friberg, LE; Hansen, K; Hassan, SB; Jonsson, E; Karlsson, MO; Larsson, R, 2000
)
0.31
" The pharmacokinetics of 5-FU and EPI were in accordance with previously established pharmacokinetic models."( Determination of drug effect on tumour cells, host animal toxicity and drug pharmacokinetics in a hollow-fibre model in rats.
Freijs, A; Friberg, LE; Hansen, K; Hassan, SB; Jonsson, E; Karlsson, MO; Larsson, R, 2000
)
0.31
" The concentrations of each drug in plasma, blood cells, bile and urine samples were determined, and by simultaneous curve-fitting of plasma and bile data according to compartmental analysis, the pharmacokinetic parameters and constants were estimated."( Contradistinction between doxorubicin and epirubicin: in-vivo metabolism, pharmacokinetics and toxicodynamics after single- and multiple-dosing in rats.
Boroujerdi, M; Ramanathan-Girish, S, 2001
)
0.57
"In order to explore activity and pharmacokinetic data of a docetaxel-epirubicin combination we analyzed a population of 60 metastatic breast cancer patients."( Clinical and pharmacokinetic data of a docetaxel-epirubicin combination in metastatic breast cancer.
Airoldi, M; Bumma, C; Cattel, L; Marchionatti, S; Pedani, F; Recalenda, V; Tagini, V, 2001
)
0.8
"Previously we observed a pharmacokinetic interference of epirubicin elimination when paclitaxel is given in combination in a sequence-dependent manner (i."( Influence of alternate sequences of epirubicin and docetaxel on the pharmacokinetic behaviour of both drugs in advanced breast cancer.
Bighin, C; Del, ML; Esposito, M; Lunardi, G; Schettini, G; Tolino, G; Vannozzi, MO; Venturini, M, 2002
)
0.83
" Pharmacokinetic data were normalised to the lower dose of each drug."( Influence of alternate sequences of epirubicin and docetaxel on the pharmacokinetic behaviour of both drugs in advanced breast cancer.
Bighin, C; Del, ML; Esposito, M; Lunardi, G; Schettini, G; Tolino, G; Vannozzi, MO; Venturini, M, 2002
)
0.59
"1 of paclitaxel suggests that the drugs might also interact at the pharmacodynamic level."( Pharmacokinetics and pharmacodynamics of combination chemotherapy with paclitaxel and epirubicin in breast cancer patients.
Baldini, E; Bocci, G; Conte, PF; Danesi, R; Del Tacca, M; Di Paolo, A; Fogli, S; Gennari, A; Innocenti, F; Salvadori, B, 2002
)
0.54
"The objectives of this study were to investigate the disposition of gemcitabine, epirubicin, paclitaxel, 2',2'-difluorodeoxyuridine and epirubicinol, and characterize the pharmacokinetic and pharmacodynamic profile of treatment in patients with breast cancer."( Gemcitabine, epirubicin and paclitaxel: pharmacokinetic and pharmacodynamic interactions in advanced breast cancer.
Conte, PF; Danesi, R; Del Tacca, M; Donati, S; Fogli, S; Gennari, A, 2002
)
0.91
" No significant pharmacokinetic interaction was observed, but a transient increase in epirubicinol plasma concentration occurred during and after docetaxel infusion."( Phase I and pharmacokinetic study of docetaxel in combination with epirubicin and cyclophosphamide in advanced cancer: dose escalation possible with granulocyte colony-stimulating factor, but not with prophylactic antibiotics.
Ackland, SP; Clarke, S; Garg, MB; Millward, MJ; Rischin, D; Smith, J; Toner, GC; Zalcberg, J, 2002
)
0.77
" Epirubicin pharmacokinetic data of seven patients were evaluated at the first cycle of therapy (baseline, with trastuzumab administered 24 h after epirubicin), and at the sixth cycle (i."( Influence of trastuzumab on epirubicin pharmacokinetics in metastatic breast cancer patients.
Bighin, C; Del Mastro, L; Lunardi, G; Schettini, G; Stevani, I; Vannozzi, MO; Venturini, M, 2003
)
1.52
"No pharmacokinetic change in the parent compound epirubicin was detected."( Influence of trastuzumab on epirubicin pharmacokinetics in metastatic breast cancer patients.
Bighin, C; Del Mastro, L; Lunardi, G; Schettini, G; Stevani, I; Vannozzi, MO; Venturini, M, 2003
)
0.87
"Enhanced anthracycline cardiotoxicity related to trastuzumab administration was not linked to pharmacokinetic interferences with epirubicin and its metabolites."( Influence of trastuzumab on epirubicin pharmacokinetics in metastatic breast cancer patients.
Bighin, C; Del Mastro, L; Lunardi, G; Schettini, G; Stevani, I; Vannozzi, MO; Venturini, M, 2003
)
0.82
" Ten limited sampling designs comprising two or three blood samples were proposed, taken at times identified by D-optimality from population pharmacokinetic parameter estimates."( Maximum a posteriori Bayesian estimation of epirubicin clearance by limited sampling.
Dobbs, NA; Ralph, LD; Thomson, AH; Twelves, C, 2004
)
0.58
"The models presented describe the dose-concentration-toxicity relationships for the FEC therapy and may provide a basis for implementation and comparison of different individualisation strategies based on covariates, therapeutic drug monitoring and/or pharmacodynamic (PD) feedback."( Population analysis of the pharmacokinetics and the haematological toxicity of the fluorouracil-epirubicin-cyclophosphamide regimen in breast cancer patients.
Bergh, J; Johansson, M; Karlsson, MO; Lindman, H; Nygren, P; Sandström, M, 2006
)
0.55
"The results of internal validation of population pharmacokinetic models should be interpreted with caution, especially when the dataset is relatively small."( Assessment of the validity of a population pharmacokinetic model for epirubicin.
Dobbs, NA; Ralph, LD; Sandstrom, M; Thomson, AH; Twelves, C, 2006
)
0.57
" Epirubicin concentrations were described by a compartmental population pharmacokinetic model (NONMEM)."( Plasma and tissue pharmacokinetics of epirubicin and Paclitaxel in patients receiving neoadjuvant chemotherapy for locally advanced primary breast cancer.
Fuhr, U; Hempel, G; Hunz, M; Jaehde, U; Jetter, A; Kurbacher, C; Pantke, E; Tuscher, M; Untch, M; Warm, M, 2007
)
1.52
"From 2002 to 2007, a total of 10 consecutive patients with Stage IVA HCC accompanied by PVTT were studied prospectively to examine the efficacy of treatment by intra-arterial infusion of a chemotherapeutic agents consisting of etoposide, carboplatin, epirubicin and pharmacokinetic modulating chemotherapy by 5-FU and enteric-coated tegafur/uracil."( Improved survival for hepatocellular carcinoma with portal vein tumor thrombosis treated by intra-arterial chemotherapy combining etoposide, carboplatin, epirubicin and pharmacokinetic modulating chemotherapy by 5-FU and enteric-coated tegafur/uracil: a p
Imai, M; Ishikawa, T; Kamimura, H; Kamimura, T; Ohta, H; Seki, K; Togashi, T; Tsuchiya, A; Watanabe, K; Yoshida, T, 2007
)
0.72
" Combination treatment did not affect pharmacokinetic parameters of capecitabine, epirubicin or their metabolites."( Dose-finding phase I and pharmacokinetic study of capecitabine (Xeloda) in combination with epirubicin and cyclophosphamide (CEX) in patients with inoperable or metastatic breast cancer.
Hozumi, Y; Ito, Y; Iwata, H; Kobayashi, T; Morita, S; Ohno, S; Saji, S; Sakamoto, J; Toi, M, 2007
)
0.79
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"Intraindividual comparative pharmacokinetic data were obtained for doxorubicin and paclitaxel/platinum in three and two baboons, respectively."( Pharmacokinetics of chemotherapeutic agents in pregnancy: a preclinical and clinical study.
Amant, F; Chai, D; de Bruijn, E; de Hoon, J; Delforge, M; Halaska, M; Heyns, L; Noens, L; Ottevanger, N; Renard, V; Rob, L; Van Bree, R; Van Calsteren, K; Verbesselt, R; Witteveen, E, 2010
)
0.36
" The pharmacokinetic model and parameters were fitted and calculated by the DAS ver2."( [Pharmacokinetics of epirubicin hydrochloride long-circulating thermosensitive liposomes in rat plasma].
Lü, WL; Mei, XG; Wu, C; Wu, Y; Zhang, FC, 2010
)
0.68
"The purpose of this study was the pharmacokinetic (PK) profile assessment in the serum of patients affected by hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) with drug-eluting beads."( Serum pharmacokinetics in patients treated with transarterial chemoembolization (TACE) using two types of epirubicin-loaded microspheres.
Bernardo, G; Di Cesare, P; Imbriani, M; Leoni, E; Minoia, C; Montagna, B; Poggi, G; Quaquarini, E; Quaretti, P; Regazzi, M; Riccardi, A; Sottani, C, 2012
)
0.59
"The pharmacokinetic study showed low peak serum epirubicin concentrations with greater drug exposure for the DC Bead® group (p<0."( Serum pharmacokinetics in patients treated with transarterial chemoembolization (TACE) using two types of epirubicin-loaded microspheres.
Bernardo, G; Di Cesare, P; Imbriani, M; Leoni, E; Minoia, C; Montagna, B; Poggi, G; Quaquarini, E; Quaretti, P; Regazzi, M; Riccardi, A; Sottani, C, 2012
)
0.85
" The peak concentration of epirubicin in the MP group and the ID group were 21."( Pharmacokinetic and myocardial enzyme profiles of two administration routes of epirubicin in breast cancer patients.
Dong, C; Feng, EF; Gao, CL; He, JC; Luo, CX; Ren, HX; Wang, XN; Yang, RX; Zhuang, L, 2012
)
0.9
" We conducted a phase I study combining VFL with epirubicin (EPR) to establish the recommended dose (RD), to evaluate the safety and efficacy profiles and to investigate potential pharmacokinetic (PK) drug-drug interaction (DDI)."( A phase I clinical and pharmacokinetic study evaluating vinflunine in combination with epirubicin as first-line treatment in metastatic breast cancer.
Bostnavaron, M; Campone, M; Chan, S; Conte, PF; Nguyen, L; Santoro, A, 2014
)
0.88
" Here, we describe an on-chip small intestine-liver coupled model for pharmacokinetic studies."( An on-chip small intestine-liver model for pharmacokinetic studies.
Fujii, T; Ikeda, T; Kimura, H; Nakayama, H; Sakai, Y, 2015
)
0.42
" The aim of this study was to evaluate the potential pharmacokinetic (PK)-based drug-drug interaction (DDI) between rilotumumab and epirubicin (E), cisplatin(C) and capecitabine (X)."( Assessment of pharmacokinetic interaction between rilotumumab and epirubicin, cisplatin and capecitabine (ECX) in a Phase 3 study in gastric cancer.
Doshi, S; Hoang, T; Kasichayanula, S; Kuchimanchi, M; Zhang, Y; Zhu, M, 2017
)
0.9
" The designed epirubicin nano-formulations achieved clinically significant pharmacokinetic values in rats."( Development and Validation of Reversed-Phase HPLC Method for the Determination of Epirubicin and Its Application to the Pharmacokinetic Study of Epirubicin Loaded Polymeric Nanoparticle Formulations in Rats.
Iftikhar, T; Iqbal, Z; Khalil, SK; Niaz, N, 2023
)
1.5
"By incorporating gestational changes into existing population pharmacokinetic models, it is possible to adequately predict plasma concentrations of drugs in pregnant patients which may inform dose adjustments in this population."( Semi-physiological Enriched Population Pharmacokinetic Modelling to Predict the Effects of Pregnancy on the Pharmacokinetics of Cytotoxic Drugs.
Amant, FCH; Beijnen, JH; Damoiseaux, D; Dorlo, TPC; Huitema, ADR; Janssen, JM; van Calsteren, K; van Hasselt, JGC, 2023
)
0.91

Compound-Compound Interactions

Study randomly selected 218 advanced primary liver carcinoma patients from Binzhou People’s Hospital, Binzhou, China. We report the use of a continuous high dose infusion of ïfosfamide at a dose of 9g/m(2) over 3 days in combination with etoposide and epirubicin.

ExcerptReferenceRelevance
" 4' epidoxorubicin combined with 5-fluorouracil given intra-arterially is not superior to the intravenous therapy, but it may diminish systemic toxicity."( Intra-arterial and intravenous use of 4' epidoxorubicin combined with 5-fluorouracil in primary hepatocellular carcinoma. A randomized comparison.
Kajanti, M; Mäntylä, M; Pyrhönen, S; Rissanen, P, 1992
)
0.28
"Repeated hepatic dearterialization combined with intra-arterial infusion chemotherapy was performed in 29 patients with unresectable primary or secondary cancer of the liver."( [Evaluation of repeated hepatic dearterialization combined with intra-arterial infusion chemotherapy of unresectable primary or secondary cancer of the liver].
Hayashi, T; Kimoto, T; Kohno, H; Makino, Y; Nagasue, N; Ohiwa, K; Ono, T; Takemoto, Y; Taniura, H; Uchida, M, 1992
)
0.28
" Chronic treatment with these drugs or each combined with ICRF-187 did not change the antioxidant levels relative to the control values."( Comparative study of doxorubicin, mitoxantrone, and epirubicin in combination with ICRF-187 (ADR-529) in a chronic cardiotoxicity animal model.
Alderton, PM; Green, MD; Gross, J, 1992
)
0.53
"From December 1986 to April 1990, 40 consecutive ovarian cancer patients who relapsed after response to cisplatin-based chemotherapy regimens were treated with seven courses of weekly cisplatin, in combination with epirubicin or etoposide."( Salvage chemotherapy for ovarian cancer recurrence: weekly cisplatin in combination with epirubicin or etoposide.
Bolis, G; Borello, C; Maggi, R; Presti, M; Scarfone, G; Zanaboni, F, 1991
)
0.69
"In the dose finding study we were able to demonstrate that an increase of the epirubicin dose to 120 mg/m2 in combination with cyclophosphamide (600 mg/m2) is possible."( High-dose epirubicin in combination with cyclophosphamide (HD-EC) in advanced breast cancer: final results of a dose finding study and phase II trial.
Adler, M; Ammon, A; Beyer, JH; Marschner, N; Nagel, GA, 1990
)
0.91
"Phase II studies of single agent and CDDP-based two drug combination were performed in 189 patients with inoperable non-small cell lung cancer."( [Phase II studies of a single agent and a cis-platinum-based two-drug combination in patients with non-small cell lung cancer].
Arai, R; Fukuoka, M; Furuse, K; Kawahara, M; Kodama, N; Matsui, K; Negoro, S; Ryu, S; Takada, M; Yamamoto, M, 1988
)
0.27
" Some of the testosterone-supplemented rats were treated with medroxyprogesterone acetate (MPA) alone or in combination with epirubicin hydrochloride."( Effect of medroxyprogesterone acetate, alone or in combination with epirubicin hydrochloride, on the growth of the Dunning R3327H prostatic adenocarcinoma.
Damber, JE; Landström, M; Tomić, R, 1987
)
0.71
"The EORTC Gastrointestinal Group has conducted a phase II trial in 47 patients with locally advanced or metastatic adenocarcinoma of the pancreas with epirubicin 90 mg/m2 intravenously on day 1 in combination with 5-fluorouracil 500 mg/m2 in a 2 hr infusion day 1-4, every 4 weeks."( An EORTC Gastrointestinal Group phase II evaluation of epirubicin combined with 5-fluorouracil in advanced adenocarcinoma of the pancreas.
Bleiberg, H; Blijham, G; Dalesio, O; Duez, N; Planting, A; Splinter, T; Weber, W; Wils, J, 1987
)
0.72
" LD-CY plus rhG-CSF in combination with CDDP or EPR mobilised a very large number of PBSC."( Low-dose cyclophosphamide in combination with cisplatin or epirubicin plus rhG-CSF allows adequate collection of PBSC for autotransplantation during adjuvant therapy for high-risk cancer.
Benedetti Panici, P; Ciarli, M; Foddai, ML; Lai, M; Menichella, G; Pierelli, L; Puglia, G; Salerno, G; Scambia, G; Serafini, R, 1994
)
0.53
" Thus, it may be concluded that M-VEC chemotherapy combined with rhG-CSF is useful in the treatment of urothelial cancer, especially when used as a neoadjuvant."( M-VEC (methotrexate, vinblastine, 4'-epirubicin and cisplatin) combined with glycosylated recombinant human granulocyte colony-stimulating factor (rhG-CSF) for the treatment of transitional cell carcinoma of urothelium: reduction in toxicity produced by r
Igawa, M; Kadena, H; Ueda, M; Usui, T, 1994
)
0.56
"To evaluate the efficacy of intra-arterial chemotherapy combined with hyperthermia for metastatic liver cancer, our cooperative study group carried out a randomized clinical trial comparing intra-arterial chemotherapy alone and intra-arterial chemotherapy combined with hyperthermia."( [A prospective randomized clinical trial comparing intra-arterial chemotherapy alone and when combined with hyperthermia for metastatic liver cancer].
Hiraoka, M; Itani, K; Kondo, M; Miura, K; Noguchi, M; Tanaka, Y; Watanabe, N; Yoshikawa, T, 1995
)
0.29
"A 64-year-old man with iliac bone metastasis from left renal cell carcinoma was treated by intra-arterial infusion chemotherapy using vinblastine and epirubicine in combination with a biscoclaurine alkaloid, Cepharanthin."( Intra-arterial infusion chemotherapy in combination with a biscoclaurine alkaloid, Cepharanthin, to treat bone metastasis arising from renal cell carcinoma.
Arai, Y; Kakehi, Y; Kanba, T; Shichiri, Y; Yoshida, O; Yoshida, S, 1994
)
0.49
"We have used a panel of bladder cancer cell lines to compare the toxicities of Adriamycin and epirubicin, two drugs used intravesically to treat superficial transitional cell cancer (TCC) of the bladder, alone and in combination with lonidamine, an agent known to be active against anthracycline-resistant disease."( Relative cytotoxicities of adriamycin and epirubicin in combination with lonidamine against human bladder cancer cell lines.
Coptcoat, M; Masters, JR; Popert, RJ; Zupi, G, 1995
)
0.77
"A total of 39 patients with breast cancer of stages I and II received breast-conservation treatment (BCT) combined with tamoxifen and systemic chemotherapy (CAF) from August 1989 to March 1993."( Early experiences of breast-conservation treatment combined with tamoxifen and CAF chemotherapy for breast cancer of stages I and II.
Araki, K; Hamada, N; Inomata, T; Kumon, M; Nishioka, A; Ogawa, Y; Ogoshi, S; Tanaka, Y; Terashima, M; Yoshida, S,
)
0.13
"The purpose of this study was to determine the maximal tolerable dose (MTD) of epirubicin and ADR-529 given in combination with cyclophosphamide, 5-fluorouracil, and tamoxifen."( The cardioprotector ADR-529 and high-dose epirubicin given in combination with cyclophosphamide, 5-fluorouracil, and tamoxifen: a phase I study in metastatic breast cancer.
Bastholt, L; Gjedde, SB; Jakobsen, P; Mirza, MR; Mouridsen, HT; Rose, C; Sørensen, B, 1994
)
0.78
"High dose epirubicin combined with cyclophosphamide is an effective treatment regimen for metastatic breast cancer obtaining higher overall response rates with increased percentage complete responses compared to conventional dose chemotherapy."( Phase II study of high dose epirubicin in combination with cyclophosphamide in patients with advanced breast cancer.
Beith, JM; Bell, D; Levi, JA; Snyder, RD; Tattersall, MH; Wheeler, H, 1995
)
0.99
"In vivo antitumor activity of pirarubicin (THP) and epirubucin (EPI) in combination with doxifluridine (5'-DFUR) and cisplatin (CDDP) were examined using mouse P388 leukemia."( Antitumor effects of pirarubicin and epirubicin in combination with doxifluridine and cisplatin against mouse P388 leukemia.
Agata, N; Hirano, S; Iguchi, H; Izumi, H; Mase, T; Takeuchi, T; Tone, H, 1995
)
0.56
"The aim of the study was to compare high-versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin as primary chemotherapy for suboptimal stage III and IV ovarian cancer."( High-dose versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: a randomized study of the Gruppo Oncologico Nord-Ovest.
Algeri, R; Bellini, A; Boccardo, F; Brunetti, I; Bruzzone, M; Carnino, F; Catsafados, E; Chiara, S; Conte, PF; Foglia, G; Gadducci, A; Gallo, L; Iskra, L; Mammoliti, S; Parodi, G; Ragni, N; Rosso, R; Rubagotti, A; Rugiati, S, 1996
)
0.29
"This study shows that doubling the dose-intensity and total dose of cisplatin in combination with epidoxorubicin and cyclophosphamide has significant toxic effects and does not improve clinical outcome in patients with suboptimal ovarian cancer."( High-dose versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: a randomized study of the Gruppo Oncologico Nord-Ovest.
Algeri, R; Bellini, A; Boccardo, F; Brunetti, I; Bruzzone, M; Carnino, F; Catsafados, E; Chiara, S; Conte, PF; Foglia, G; Gadducci, A; Gallo, L; Iskra, L; Mammoliti, S; Parodi, G; Ragni, N; Rosso, R; Rubagotti, A; Rugiati, S, 1996
)
0.29
"The combination of sequential high dose methotrexate and 5-fluorouracil (FU) combined with epirubicin (FEMTX regimen) has shown some clinical efficiency as a first line therapy in advanced gastric cancer."( Ineffectiveness of sequential high dose methotrexate and 5-fluorouracil combined with epirubicin (FEMTX regimen) as a salvage therapy in advanced colorectal cancers and other gastrointestinal tumors.
Adenis, A; Bonneterre, J; Leriche, N; Pion, JM; Vanlemmens, L,
)
0.58
"The in vitro predictive chemosensitivity of a HeLa-S3 human cervical cancer cell line to a new series of Cu(II) complexes as well as their combination with several chemotherapeutic drugs was determined."( In vitro synergistic effects of some novel Cu(II) complexes in combination with epirubicin and mitomycin C against HeLa-S3 cervical cancer cell line.
Geromichalos, GD; Hadjikostas, CC; Katsoulos, GA; Kortsaris, AH; Kyriakidis, DA, 1996
)
0.52
" After three courses of neoadjuvant chemotherapy combined with G-CSF and/or PBSCT reinfusion, the breast cancer revealed a remarkable size reduction and was absent from direct thoracic and pectoral muscle, invasion within the physical status and visual analysis by CT scan."( [A case report of neoadjuvant intra-arterial injection chemotherapy combined with peripheral blood stem cell reinfusion in an advanced breast cancer patient].
Idezuki, Y; Inokuma, S; Ishizuka, N; Kobayashi, M; Maeda, H; Miura, T; Murata, N; Suwata, J; Takada, S, 1998
)
0.3
" The use of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) in combination with anthracyclines is also active and could represent a safe and favorable alternative."( Taxoids in combination with epirubicin: the search for improved outcomes in breast cancer.
Pagani, O, 1998
)
0.59
" The authors conducted this Phase II study to determine the feasibility, toxicity, and antitumor activity of suramin in combination with epirubicin."( Suramin in combination with weekly epirubicin for patients with advanced hormone-refractory prostate carcinoma.
Allegrini, G; Antonuzzo, A; Conte, P; Danesi, R; Del Tacca, M; Falcone, A; Masi, G; Monica, L; Pfanner, E; Ricci, S, 1999
)
0.78
" In conclusion, besides confirming that intraperitoneal chemotherapy is feasible with acceptable toxicity but with poor compliance in community hospitals, this trial showed that intraperitoneal CDDP compared with intravenous CDDP in combination with EPIDOX and CTX obtained a slight (not significant) improvement in progression-free survival and overall survival of optimally cytoreduced advanced ovarian cancer patients."( Intraperitoneal versus intravenous cisplatin in combination with intravenous cyclophosphamide and epidoxorubicin in optimally cytoreduced advanced epithelial ovarian cancer: a randomized trial of the Gruppo Oncologico Nord-Ovest.
Brunetti, I; Bruzzone, M; Carnino, F; Chiara, S; Conte, PF; Gadducci, A; Romanini, A; Tanganelli, L, 2000
)
0.31
"To evaluate safety and efficacy of high-dose epirubicin combined with cyclophosphamide and fluorouracil for advanced breast cancer."( [A clinical report of high-dose epirubicin combined with cyclophosphamide and fluorouracil for advanced breast cancer].
Dai, A; Feng, J; Zheng, X, 1998
)
0.84
"High-dose EPI combined with CTX, 5-Fu is a safe and effective regimen for patients with advanced breast cancer worthy of further clinical trial."( [A clinical report of high-dose epirubicin combined with cyclophosphamide and fluorouracil for advanced breast cancer].
Dai, A; Feng, J; Zheng, X, 1998
)
0.58
" We report the use of a continuous high dose infusion of ïfosfamide at a dose of 9g/m(2) over 3 days in combination with etoposide and epirubicin followed by autologous stem cell transplant with either BEAM or Melphalan/VP16 conditioning in this difficult group."( High dose ifosfamide in combination with etoposide and epirubicin followed by autologous stem cell transplantation in the treatment of relapsed/refractory Hodgkin's disease: a report on toxicity and efficacy.
Angus, B; Carey, PJ; Finney, RD; Galloway, MJ; Goff, DK; Haynes, A; Jackson, GH; Lennard, AL; Leonard, RC; McQuaker, IG; Proctor, SJ; Russell, N; Taylor, PR; Windebank, K, 2000
)
0.76
" MV represents a chemotherapy combination with equivalent efficacy to standard FAC/FEC and improved results for patients who have previously received adjuvant chemotherapy."( Results of a phase III prospective, randomised trial, comparing mitoxantrone and vinorelbine (MV) in combination with standard FAC/FEC in front-line therapy of metastatic breast cancer.
Calais, G; Chinet-Charrot, P; Clavère, P; Colin, P; de Gislain, C; Delozier, T; Etienne, PL; Eymard, JC; Ganem, G; Luporsi, E; Maillart, P; Marti, P; Namer, M; Pouillart, P; Prevost, G; Romieu, G; Schraub, S; Serin, D; Soler-Michel, P; Tigaud, D; Trillet-Lenoir, V; Turpin, F; Wendling, JL, 2001
)
0.31
" Eight patients were included in the study: six received paclitaxel in combination with epirubicin and cisplatin, and two received paclitaxel as a single agent."( Pharmacologic study of paclitaxel administered with or without the cytoprotective agent amifostine, and given as a single agent or in combination with epirubicin and cisplatin in patients with advanced solid tumors.
Beijnen, JH; Hoekman, K; Huijskes, RV; Nannan Panday, VR; Rosing, H; Van den Brande, J; Verheijen, RH; Vermorken, JB, 2001
)
0.73
"To define the dose-limiting toxicities (DLTs) and the maximum tolerated doses (MTDs) of topotecan in combination with epirubicin in pretreated patients with small-cell lung cancer (SCLC)."( A dose escalation study of topotecan in combination with epirubicin in pretreated patients with small-cell lung cancer.
Agelaki, S; Georgoulias, V; Kakolyris, S; Kalbakis, K; Kouroussis, C; Mavroudis, D; Palamidas, P; Raptis, A, 2001
)
0.76
"The purpose of this study was to analyze the drug interactions of paclitaxel (PTX) with epirubicin (EPI), carboplatin (CBDCA), gemcitabine (GEM) and vinorelbine (VIN) in human breast cancer cells and compare the cytotoxic activity of each drug combination in primary breast cancer samples."( Drug interactions and cytotoxic effects of paclitaxel in combination with carboplatin, epirubicin, gemcitabine or vinorelbine in breast cancer cell lines and tumor samples.
Beryt, M; Felber, M; Hepp, H; Kahlert, S; Konecny, G; Langer, E; Lude, S; Pegram, M; Slamon, D; Untch, M, 2001
)
0.76
"Large pivotal phase II and III clinical trials investigated the therapeutic efficacy and safety of the humanized anti-HER2 monoclonal antibody, Herceptin, alone and in combination with standard chemotherapy, respectively, in HER2-positive metastatic breast cancer."( Herceptin alone or in combination with chemotherapy in the treatment of HER2-positive metastatic breast cancer: pivotal trials.
Baselga, J, 2001
)
0.31
"The aim of this study was to evaluate the clinical effectiveness of intra-arterial chemotherapy combined with degradable starch microspheres (DSM) for liver metastases and the possibility of predicting the effectiveness of the chemotherapy by pretreatment diagnostic imaging."( [Clinical effectiveness of intra-arterial chemotherapy combined with degradable starch microspheres (DSM) for liver metastases and prediction of effectiveness by diagnostic imaging].
Majima, T; Nakajima, T; Nozu, S; Okayasu, K; Saitou, AY; Yagi, A, 2001
)
0.31
" The main objective of this study was to determine the maximum tolerated dose (MTD) of epirubicin when given in combination with fixed doses of cyclophosphamide and infusional 5-fluorouracil (CEF-infu) as neoadjuvant therapy in patients with LO or LA/I BC for a maximum of 6 cycles."( An EORTC phase I study of epirubicin in combination with fixed doses of cyclophosphamide and infusional 5-fu (CEF-infu) as primary treatment of large operable or locally advanced/inflammatory breast cancer.
Biganzoli, L; Bonnefoi, H; Cufer, T; Hamilton, A; Mauriac, L; Piccart, M; Schaefer, P, 2001
)
0.83
"The purpose of this study was to evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose of capecitabine when used in combination with epirubicin and cisplatin (ECC) in patients with oesophageal or gastric adenocarcinoma."( A phase I and pharmacokinetic study of capecitabine in combination with epirubicin and cisplatin in patients with inoperable oesophago-gastric adenocarcinoma.
Blackie, R; Evans, TR; Fullarton, GM; McDonald, AC; McInnes, A; Morrison, R; Paul, J; Pentheroudakis, G; Raby, N; Soukop, M, 2002
)
0.75
"A dose of 1000 mg/m(2) bd of capecitabine is recommended for use on an intermittent schedule in combination with these doses and schedule of epirubicin and cisplatin."( A phase I and pharmacokinetic study of capecitabine in combination with epirubicin and cisplatin in patients with inoperable oesophago-gastric adenocarcinoma.
Blackie, R; Evans, TR; Fullarton, GM; McDonald, AC; McInnes, A; Morrison, R; Paul, J; Pentheroudakis, G; Raby, N; Soukop, M, 2002
)
0.75
"The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as first-line treatment for patients with locally advanced/metastatic breast carcinoma."( Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated, advanced breast carcinoma.
Bighin, C; Colozza, MA; Contu, A; Del Mastro, L; Durando, A; Garrone, O; Genta, F; Lambiase, A; Stevani, I; Venturini, M, 2003
)
0.78
" The main objective of this study was to determine the maximum tolerated dose (MTD) of capecitabine when given in combination with fixed doses of epirubicin and cyclophosphamide (100 and 600 mg/m(2) day 1 every (q) 3 weeks) as primary treatment for large operable or locally advanced/inflammatory breast cancer without distant metastasis."( An EORTC phase I study of capecitabine (Xeloda) in combination with fixed doses of cyclophosphamide and epirubicin (cex) as primary treatment for large operable or locally advanced/inflammatory breast cancer.
Atalay, G; Biganzoli, L; Bonnefoi, H; Cufer, T; Mauriac, L; Piccart, M; Schaefer, P, 2003
)
0.73
" A phase I study was carried out to evaluate the dose-limiting toxicity (DLT) and the maximally tolerated dose (MTD) of PXT and EPI in combination with a fixed dose of cisplatin every 4 weeks."( Escalating doses of paclitaxel and epirubicin in combination with cisplatin in advanced ovarian epithelial carcinoma: a phase I-II study.
Benedetti Panici, P; Borsellino, N; Citarrella, P; Di Marco, P; Fallica, G; Gebbia, N; Gebbia, V; Tirrito, ML; Valenza, R; Valerio, MR, 2003
)
0.6
" The mobilizing regimen consisted of high-dose epirubicin 150 mg/m(2), preceded by dexrazoxane 1000 mg/m(2) (day 1), given in combination with paclitaxel 175 mg/m(2) (day 2), plus filgrastim."( High-dose epirubicin, preceded by dexrazoxane, given in combination with paclitaxel plus filgrastim provides an effective mobilizing regimen to support three courses of high-dose dense chemotherapy in patients with high-risk stage II-IIIA breast cancer.
Baioni, M; Ballardini, M; De Giorgi, U; Ferrari, E; Marangolo, M; Minzi, MR; Rosti, G; Zaniboni, A; Zornetta, L, 2003
)
0.98
" These data provide a proof-of-principle for the clinical use of LErafAON in combination with chemotherapy for cancer treatment."( Combination with liposome-entrapped, ends-modified raf antisense oligonucleotide (LErafAON) improves the anti-tumor efficacies of cisplatin, epirubicin, mitoxantrone, docetaxel and gemcitabine.
Ahmad, I; Dritschilo, A; Gokhale, PC; Kasid, UN; Pei, J; Rahman, A; Zhang, C, 2004
)
0.53
"A phase I clinical trial was started in order to determine the recommended doses of capecitabine and epirubicin, when administered in combination with a fixed dose of cyclophosphamide (600 mg/m(2) day 1 q3 weeks) in patients with inoperable or recurrent breast cancer."( Application of a continual reassessment method to a phase I clinical trial of capecitabine in combination with cyclophosphamide and epirubicin (CEX) for inoperable or recurrent breast cancer.
Hozumi, Y; Ito, Y; Iwata, H; Kobayashi, T; Morita, S; Ohno, S; Sakamoto, J; Toi, M, 2004
)
0.74
" These results indicate that trastuzumab may be combined with EC with manageable cardiotoxicity and promising efficacy."( Cardiac safety of trastuzumab in combination with epirubicin and cyclophosphamide in women with metastatic breast cancer: results of a phase I trial.
Blohmer, JU; du Bois, A; Ebert, A; Eidtmann, H; Emons, G; Harbeck, N; Heilman, V; Höffken, K; Jackisch, C; Kuhn, W; Langer, B; Lück, HJ; Meerpohl, HG; Muscholl, M; Pauschinger, M; Reichardt, P; Thomssen, Ch; Untch, M; Wallwiener, D; Wiese, W, 2004
)
0.58
"This study was originally designed as a phase I/II study, with a dose escalation of docetaxel in combination with epirubicin 50 mg m(-2) and 5-fluorouracil (5-FU) 200 mg m(-2) day(-1)."( Phase II study of docetaxel in combination with epirubicin and protracted venous infusion 5-fluorouracil (ETF) in patients with recurrent or metastatic breast cancer. A Yorkshire breast cancer research group study.
Bradley, C; Crawford, SM; Dent, J; Dodwell, D; Humphreys, AC; Joffe, JK; Perren, TJ; Rodwell, S, 2004
)
0.79
" The current study was performed to evaluate the outcome of patients with advanced hepatic hilar duct carcinoma who received external beam radiotherapy (EBRT) combined with transarterial chemotherapy and infusion of a vasoconstrictor."( Radiotherapy combined with transarterial infusion chemotherapy and concurrent infusion of a vasoconstrictor agent for nonresectable advanced hepatic hilar duct carcinoma.
Hori, Y; Kiyosue, H; Komatsu, E; Matsumoto, A; Matsumoto, S; Mori, H; Tomonari, K; Wakisaka, M, 2004
)
0.32
"The present study aimed to evaluate the side-effects and efficacy of thalidomide in combination with an anthracycline-containing chemotherapy regimen in previously untreated myeloma patients."( Thalidomide in combination with vincristine, epirubicin and dexamethasone (VED) for previously untreated patients with multiple myeloma.
Bojko, P; Brandhorst, D; Buttkereit, U; Ebeling, P; Flasshove, M; Hense, J; Hoiczyk, M; Metz, K; Moritz, T; Nowrousian, MR; Opalka, B; Schütt, P; Seeber, S, 2005
)
0.59
"A multicenter randomized study comparing high dose of mitomycin and epirubicin given as hepatic intra-arterial chemotherapy (HIAC) combined with caval chemofiltration (CF) versus low doses of the same drugs in unresectable liver metastases from colorectal cancer showed a significant improvement in the survival rate of the 20 patients treated with high dose compared to the 22 patients treated with low doses with a 1 year survival of 69% vs 39%."( Hepatic intra-arterial chemotherapy (HIAC) of high dose mitomycin and epirubicin combined with caval chemofiltration versus prolonged low doses in liver metastases from colorectal cancer: a prospective randomized clinical study.
Bernardeschi, P; Cantore, M; De Simone, M; Dentico, P; Fiorentini, G; Guadagni, S; Poddie, DB; Rossi, G; Rossi, S; Tumolo, S; Valori, VM, 2004
)
0.79
"Dex combined with GS markedly decreased the occurrence ratio and lasting time of the symptoms such as nausea, vomiting, fever and pain, and protected the function of liver as compared with the placebo (P<0."( [Ginsenosides combined with dexamethasone in preventing and treating postembolization syndrome following transcatheter arterial chemoembolization: a randomized, controlled and double-blinded prospective trial].
Chen, Z; Feng, YL; Li, B; Ling, CQ; Yu, CQ; Zhu, DZ, 2005
)
0.33
"Dex combined with GS can effectively prevent and treat the postembolization syndrome following TACE."( [Ginsenosides combined with dexamethasone in preventing and treating postembolization syndrome following transcatheter arterial chemoembolization: a randomized, controlled and double-blinded prospective trial].
Chen, Z; Feng, YL; Li, B; Ling, CQ; Yu, CQ; Zhu, DZ, 2005
)
0.33
" This study was to explore treatment value and efficacy of percutaneous vertebroplasty (PVP) combined with interventional chemotherapy on vertebral metastases."( [Treatment effect of percutaneous vertebroplasty combined with interventional chemotherapy on vertebral metastases].
Cai, HY; Cao, HP; Dong, XC; Liu, XD; Wang, XQ; Zhang, ZY, 2005
)
0.33
"Seventy-five patients with vertebral metastases (42 men, 33 women; aged 31-76 years) were divided into 2 groups: 39 were treated by PVP combined with chemotherapy (VPCC group), and 36 were treated by PVP alone (VP group)."( [Treatment effect of percutaneous vertebroplasty combined with interventional chemotherapy on vertebral metastases].
Cai, HY; Cao, HP; Dong, XC; Liu, XD; Wang, XQ; Zhang, ZY, 2005
)
0.33
"The recommended dose of epirubicin for phase II studies is 30 mg/m2 in combination with gefitinib at the daily dose of 250 mg."( Gefitinib (ZD1839) combined with weekly epirubicin in patients with metastatic breast cancer: a phase I study with biological correlate.
Amici, S; Gasparini, G; Gattuso, D; Gion, M; Longo, R; Sarmiento, R; Zancan, M, 2005
)
0.9
"The primary objective of study is to evaluate cardiac safety of trastuzumab in combination with epirubicin and docetaxel."( Multicenter phase II study of trastuzumab in combination with epirubicin and docetaxel as first-line treatment for HER2-overexpressing metastatic breast cancer.
Bighin, C; Cappuzzo, F; Del Mastro, L; Durando, A; Lambiase, A; Monfardini, S; Nicoletto, O; Olmeo, N; Puglisi, F; Venturini, M, 2006
)
0.79
"This is the first study investigating neoadjuvant interstitial high-dose-rate (HDR) brachytherapy combined with chemotherapy in patients with breast cancer."( Neoadjuvant interstitial high-dose-rate (HDR) brachytherapy combined with systemic chemotherapy in patients with breast cancer.
Baltas, D; Filipowicz, I; Hoffmann, G; Kolotas, C; Kontova, M; Kuner, RP; Kurek, R; Martin, T; Pollow, B; Roddiger, SJ; Rogge, B; Zamboglou, N, 2006
)
0.33
" The patients received a neoadjuvant protocol consisting of systemic chemotherapy combined with fractionated HDR brachytherapy (2 x 5 Gy/day, total dose 30 Gy)."( Neoadjuvant interstitial high-dose-rate (HDR) brachytherapy combined with systemic chemotherapy in patients with breast cancer.
Baltas, D; Filipowicz, I; Hoffmann, G; Kolotas, C; Kontova, M; Kuner, RP; Kurek, R; Martin, T; Pollow, B; Roddiger, SJ; Rogge, B; Zamboglou, N, 2006
)
0.33
"We conducted a dose-escalating, single arm, prospective, open label, non-randomised phase I trial of epirubicin (75 mg/m(2)) in combination with escalating oral doses of sulindac (0-800 mg) in patients with advanced cancer to identify an appropriate dose of sulindac to use in future resistance studies."( A phase I clinical and pharmacokinetic study of the multi-drug resistance protein-1 (MRP-1) inhibitor sulindac, in combination with epirubicin in patients with advanced cancer.
Arnold, RD; Ballot, J; Clynes, M; Collins, CD; Crown, J; Fennelly, D; Kennedy, S; Kinsella, P; Larkin, A; Mager, DE; O'Connor, R; O'Driscoll, L; O'Leary, M, 2007
)
0.76
" 3DCRT was given with the field covering the tumor with a generous margin."( [Three-dimensional conformal radiotherapy combined with transcatheter arterial chemoembolization for hepatocellular carcinoma].
Chen, Z; Cheng, WW; Jiang, GL; Lin, JH; Liu, LM; Meng, ZQ; Zhang, XJ; Zhou, ZH, 2006
)
0.33
"3DCRT combined with TACE is safe and effective for HCC."( [Three-dimensional conformal radiotherapy combined with transcatheter arterial chemoembolization for hepatocellular carcinoma].
Chen, Z; Cheng, WW; Jiang, GL; Lin, JH; Liu, LM; Meng, ZQ; Zhang, XJ; Zhou, ZH, 2006
)
0.33
"Bladder cancer cells were exposed to MeEPA in combination with epirubicin or mitomycin."( Meglumine Eicosapentaenoic acid (MeEPA) a new soluble omega-3 fatty acid formulation: in vitro bladder cancer cytotoxicity tests in combination with epirubicin and mitomycin.
Cooper, AJ; Harris, NM; Lwaleed, BA; Mackie, SJ; Sharma, DM, 2006
)
0.77
"To investigate the immunoregulation and short-term therapeutic effects of super-selective intra-arterial chemotherapy combined with Fuzheng Kang'ai Granules, a compound Chinese herbal medicine, on patients with late gastric cancer."( [Immunoregulation and short-term therapeutic effects of super-selective intra-arterial chemotherapy combined with traditional Chinese drugs on gastric cancer patients].
Fang, C; Song, MQ; Sun, Q; Wang, L; Zhu, JS; Zhu, L, 2006
)
0.33
"The super-selective intra-arterial chemotherapy combined with Fuzheng Kang'ai Granules has good short-term therapeutic efficiency and few side effects for patients with late gastric antrum cancer."( [Immunoregulation and short-term therapeutic effects of super-selective intra-arterial chemotherapy combined with traditional Chinese drugs on gastric cancer patients].
Fang, C; Song, MQ; Sun, Q; Wang, L; Zhu, JS; Zhu, L, 2006
)
0.33
"The TEXAS (Taxotere EXperience with Anthracyclines Study) study examined docetaxel in combination with an anthracycline, as first line treatment of metastatic breast cancer (MBC), in everyday practice, and compared the findings with a randomised controlled trial."( TEXAS (Taxotere EXperience with Anthracyclines Study) trial: mature results of activity/toxicity of docetaxel given with anthracyclines in a community setting, as first line therapy for MBC.
Barrett-Lee, P; Grieve, R; Houston, S; Howell, A; Johnston, S; Leonard, R; Malinovszky, K; O'Reilly, S; Verrill, M; Wardley, A, 2007
)
0.34
"CEX represents a well-tolerated regimen, and RD for Japanese patients was determined to be capecitabine 900 mg/m(2) twice daily in combination with epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2) using the CRM."( Dose-finding phase I and pharmacokinetic study of capecitabine (Xeloda) in combination with epirubicin and cyclophosphamide (CEX) in patients with inoperable or metastatic breast cancer.
Hozumi, Y; Ito, Y; Iwata, H; Kobayashi, T; Morita, S; Ohno, S; Saji, S; Sakamoto, J; Toi, M, 2007
)
0.76
" Here we adopted suspension culture combined with anticancer regimens as a strategy for screening breast cancer stem cells (BrCSCs)."( Suspension culture combined with chemotherapeutic agents for sorting of breast cancer stem cells.
Li, HZ; Wu, ZY; Yi, TB, 2008
)
0.35
" Cells of passage 10 were treated in combination with anticancer agents pacilitaxel and epirubicin at different peak plasma concentrations for 24 hours, and then maintained under suspension culture."( Suspension culture combined with chemotherapeutic agents for sorting of breast cancer stem cells.
Li, HZ; Wu, ZY; Yi, TB, 2008
)
0.57
"Suspension culture combined with anticancer regimens provides an effective means of isolating, culturing and purifying BrCSCs."( Suspension culture combined with chemotherapeutic agents for sorting of breast cancer stem cells.
Li, HZ; Wu, ZY; Yi, TB, 2008
)
0.35
"To evaluate the efficacy and safety of high doses of thymopentin (10 mg/d) combined with transartery chemoembolization for primary liver cancer."( [Study on the efficacy and safety of high dose thymopentin combined with trans-artery chemoembolization for primary liver cancer].
Li, T; Li, ZW; Wen, HC, 2007
)
0.34
"Transartery chemoembolization combined with high dose of thymopentin in the treatment for primary liver cancer is effective and safe, and can significantly improve the immune function and the chemotherapy tolerance."( [Study on the efficacy and safety of high dose thymopentin combined with trans-artery chemoembolization for primary liver cancer].
Li, T; Li, ZW; Wen, HC, 2007
)
0.34
"To assess efficacy of transcatheter arterial chemoembolization (TACE) combined with degradable starch microspheres (DSM) for patients with liver cirrhosis and hepatocellular carcinoma (HCC)."( Oily chemoembolization combined with degradable starch microspheres for HCC with cirrhosis.
Ichikawa, K; Kumita, S; Murata, S; Nomura, K; Onozawa, S; Tajima, H; Wang, J,
)
0.13
" Fifty-two patients received TACE combined with pravastatin (20-40 mg/day) and 131 patients received chemoembolization alone."( Chemoembolization combined with pravastatin improves survival in patients with hepatocellular carcinoma.
Dogan, S; Goke, B; Graf, H; Helmberger, T; Hoffmann, RT; Jakobs, T; Jüngst, C; Jüngst, D; Reiser, M; Seidel, D; Straub, G; Waggershauser, T; Walli, A; Walter, A, 2008
)
0.35
"The aim of the present study was to evaluate the effectiveness of bortezomib combined with epirubicin, dexamethasone, and thalidomide (BADT) for the treatment of multiple myeloma (MM)."( Bortezomib in combination with epirubicin, dexamethasone and thalidomide is a highly effective regimen in the treatment of multiple myeloma: a single-center experience.
Hu, X; Huang, C; Lü, S; Ni, X; Qiu, H; Wang, J; Xu, X; Yang, J, 2009
)
0.86
"We conducted a phase II study to evaluate the efficacy and toxicity of weekly docetaxel combined with epirubicin on D15 as second-line chemotherapy in Taiwanese patients with advanced non small cell lung cancer (NSCLC) who failed or relapsed after the frontline platinum-based chemotherapy."( Phase II study of epirubicin in combination with weekly docetaxel for patients with advanced NSCLC who have failed or relapsed after the frontline platinum-based chemotherapy.
Chang, JW; Chen, CH; Lin, CM; Tsao, TC, 2009
)
0.9
"To evaluate the effects and toxicity of the neoadjuvant chemotherapy of docetaxel combined with epirubicin or pirarubicin on breast cancer, and to investigate the influencing factors of the response to neoadjuvant chemotherapy."( [Effects of neoadjuvant chemotherapy of docetaxel combined with and epirubicin or pirarubicin on breast cancer: clinical analysis of 160 cases].
Chen, YQ; Jin, YC; Kong, QL; Li, J; Li, R; Li, XR; Ma, B; Wang, JD; Zhang, YJ; Zheng, YQ, 2009
)
0.81
"To investigate the efficiency, time to progression (TTP), overall survival (OS) and toxicity of epirubicin combined with DDP and 5-Fu (PELF regimen) for the treatment of advanced gastric cancer."( [Epirubicin combined with DDP and 5-Fu for treatment of advanced gastric cancer].
Li, J; Li, Y; Lu, M; Shen, L; Zhang, XD, 2009
)
1.48
"The regimen of epirubicin combined with DDP and 5-Fu is effective, well tolerable and safe for advanced gastric cancer patients either as adjuvant or as palliative therapy."( [Epirubicin combined with DDP and 5-Fu for treatment of advanced gastric cancer].
Li, J; Li, Y; Lu, M; Shen, L; Zhang, XD, 2009
)
1.62
"To explore the efficacy of intraperitoneally injected epirubicin (EPI)-loaded poly (d, l)-lactic acid (PLA) microspheres (MS) alone or combined with free epirubicin (FEPI) in treating hepatocellular carcinoma (HCC) in mice."( [Efficacy of intraperitoneally injected epirubicin-loaded poly (d, l)-lactic acid microspheres alone or combined with free epirubicin in treating hepatocellular carcinoma in mice].
Wang, XM; Ye, SF; Zhang, QQ; Zhou, JY, 2009
)
0.87
"EPI-PLA-MS combined with FEPI is highly effective in treating HCC in mice when intraperitoneally injected."( [Efficacy of intraperitoneally injected epirubicin-loaded poly (d, l)-lactic acid microspheres alone or combined with free epirubicin in treating hepatocellular carcinoma in mice].
Wang, XM; Ye, SF; Zhang, QQ; Zhou, JY, 2009
)
0.62
"The cancer stem cells (CSCs) from human osteosarcoma by serum-free three-dimensional culture combined with anticancer drugs were isolated and identified."( Isolation and identification of cancer stem cells from human osteosarcom by serum-free three-dimensional culture combined with anticancer drugs.
Chen, W; Fang, Z; Li, F; Niu, P; Xiao, J; Xiong, W; Zhou, S, 2010
)
0.36
"An in vivo study on enhancing antitumor effect of intravenous epirubicin hydrochloride (EPI) by acoustic cavitation in situ combined with phospholipid-based microbubbles (PMB) was reported."( Experiment on enhancing antitumor effect of intravenous epirubicin hydrochloride by acoustic cavitation in situ combined with phospholipid-based microbubbles.
Huang, PT; Li, WF; Li, XK; Lu, CT; Sun, CZ; Tian, XQ; Wu, Y; Zhang, L; Zhao, YZ, 2011
)
0.86
" An effective retardation on tumor growth and improved mice survival status were observed when intravenous EPI combined with sonicated PMB in situ."( Experiment on enhancing antitumor effect of intravenous epirubicin hydrochloride by acoustic cavitation in situ combined with phospholipid-based microbubbles.
Huang, PT; Li, WF; Li, XK; Lu, CT; Sun, CZ; Tian, XQ; Wu, Y; Zhang, L; Zhao, YZ, 2011
)
0.62
"Intravenous EPI combined with PMB-mediated cavitation in situ might provide a potential application for US-mediated chemotherapy."( Experiment on enhancing antitumor effect of intravenous epirubicin hydrochloride by acoustic cavitation in situ combined with phospholipid-based microbubbles.
Huang, PT; Li, WF; Li, XK; Lu, CT; Sun, CZ; Tian, XQ; Wu, Y; Zhang, L; Zhao, YZ, 2011
)
0.62
"The purpose of this study was to evaluate the efficacy and safety of Zoladex combined with CEF chemotherapy as neoadjuvant therapy in hormone-responsive, premenopausal, operable breast cancer."( A Phase II trial of Zoladex combined with CEF chemotherapy as neoadjuvant therapy in premenopausal women with hormone-responsive, operable breast cancer.
Cui, S; Liu, J; Qin, L; Zhang, C; Zhang, J; Zhang, S, 2012
)
0.38
" The aim of the present study was to assess the therapeutic effects of repeated radiofrequency ablation (RFA) combined with chemoembolization on SHHCC."( Solitary huge hepatocellular carcinomas 10 cm or larger may be completely ablated by repeated radiofrequency ablation combined with chemoembolization: Initial experience with 9 patients.
Cao, B; Ding, X; Gao, J; Gao, K; Ke, S; Li, M; Qian, X; Sun, W, 2012
)
0.38
"This study examined the efficacy and tolerability of docetaxel(DOC)in combination with epirubicin(EPI)as the first-line treatment for patients with advanced and recurrent breast cancer."( [Docetaxel in combination with epirubicin as the first-line chemotherapy for advanced and recurrent breast cancer: a multicenter phase II study].
Anan, K; Arime, I; Chijiiwa, K; Fujii, T; Hara, S; Imamura, S; Inoue, H; Ishikawa, E; Mitsuyama, S; Nishimura, R; Ohchi, T; Ohkido, M; Ohno, S; Oikawa, T; Shimada, K; Tamura, K; Tanaka, M; Taniguchi, H; Yano, H, 2012
)
0.89
" The maximum-tolerated dose of ixabepilone in combination with epirubicin was 30 mg/m2 (the recommended dose for phase II evaluation), and the dose-limiting toxicity dose was 35 mg/m2 with grade 4 neutropenia."( A phase I study of ixabepilone in combination with epirubicin in patients with metastatic breast cancer.
Cottura, E; Dalenc, F; De Benedictis, E; Deslandres, M; Gianni, L; Gladieff, L; Govi, S; Locatelli, A; Messina, M; Roché, H; Zambetti, M, 2012
)
0.87
"The objectives of this phase I trial were to determine the maximum-tolerated dose (MTD), toxicity profile, dose-limiting toxicities (DLT), pharmacokinetics, and the recommended phase II dose for ixabepilone in combination with epirubicin in women with metastatic breast cancer."( A phase I study of ixabepilone in combination with epirubicin in patients with metastatic breast cancer.
Cottura, E; Dalenc, F; De Benedictis, E; Deslandres, M; Gianni, L; Gladieff, L; Govi, S; Locatelli, A; Messina, M; Roché, H; Zambetti, M, 2012
)
0.81
"Forty-two women were treated at 3 different dose levels of ixabepilone: 25 (n = 6), 30 (n = 30), and 35 mg/m(2) (n = 6) in combination with 75 mg/m(2) epirubicin."( A phase I study of ixabepilone in combination with epirubicin in patients with metastatic breast cancer.
Cottura, E; Dalenc, F; De Benedictis, E; Deslandres, M; Gianni, L; Gladieff, L; Govi, S; Locatelli, A; Messina, M; Roché, H; Zambetti, M, 2012
)
0.83
" The results suggest that capecitabine may be useful in combination with standard fluorouracil-based regimens in patients with advanced and/or metastatic gastric cancer with favourable safety profile."( Incidence of hand-foot syndrome with capecitabine in combination with chemotherapy as first-line treatment in patients with advanced and/or metastatic gastric cancer suitable for treatment with a fluoropyrimidine-based regimen.
Aparicio, J; Dueñas, R; Falcó, E; Gómez-Martin, C; Irigoyen, A; Lacasta, A; Llorente, B; López, RL; Muñoz, ML; Pérez, B; Reboredo, M; Regueiro, P; Safont, MJ; Sánchez, A; Sanchez-Viñes, E; Serrano, R, 2012
)
0.38
"To compare the efficacy of intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone for T1G3 bladder transitional cell carcinoma (BTCC) followed by bladder-preserving surgery."( Comparing intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone: a randomised prospective pilot study for T1G3 bladder transitional cell carcinoma after bladder-preserving surgery.
Chen, J; Chen, L; Li, J; Qiu, S; Wang, Y; Yang, J; Yao, Z, 2013
)
0.39
" After bladder-preserving surgery, 29 patients (age 30-80 years, 24 male and 5 female) received intra-arterial chemotherapy in combination with intravesical chemotherapy (group A), whereas 31 patients (age 29-83 years, 26 male and 5 female) were treated with intravesical chemotherapy alone (group B)."( Comparing intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone: a randomised prospective pilot study for T1G3 bladder transitional cell carcinoma after bladder-preserving surgery.
Chen, J; Chen, L; Li, J; Qiu, S; Wang, Y; Yang, J; Yao, Z, 2013
)
0.39
" The purpose of the present study was to validate prior results that tissue inhibitor of metalloproteinase 1 (TIMP-1) alone or in combination with either HER2 or TOP2A copy number can be used to predict benefit from epirubicin (E) containing chemotherapy compared with cyclophosphamide, methotrexate and fluorouracil (CMF) treatment."( Is TIMP-1 immunoreactivity alone or in combination with other markers a predictor of benefit from anthracyclines in the BR9601 adjuvant breast cancer chemotherapy trial?
Balslev, E; Bartels, A; Bartlett, JM; Brünner, N; Cameron, DA; Munro, AF; Twelves, CJ, 2013
)
0.58
" The critical role of angiogenesis in the progression of breast cancer, together with significantly improved efficacy when bevacizumab is combined with chemotherapy in the metastatic setting, provides a strong rationale for evaluating the integration of bevacizumab into neoadjuvant chemotherapy regimens."( Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer.
Aitini, E; Bighin, C; Bisagni, G; Clavarezza, M; De Placido, S; Del Mastro, L; Durando, A; Galli, A; Garrone, O; Levaggi, A; Restuccia, E; Saracchini, S; Scalamogna, R; Turazza, M, 2013
)
0.39
"A single-arm, multicentre, phase II, open-label study evaluated four 3-weekly cycles of FEC (5-fluorouracil 600 mg/m(2), epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)) followed by 12 cycles of weekly paclitaxel (80 mg/m(2)) in combination with bevacizumab 10 mg/kg every 2 weeks as neoadjuvant therapy for HER2-negative stage III locally advanced or inflammatory breast carcinoma."( Phase II open-label study of bevacizumab combined with neoadjuvant anthracycline and taxane therapy for locally advanced breast cancer.
Aitini, E; Bighin, C; Bisagni, G; Clavarezza, M; De Placido, S; Del Mastro, L; Durando, A; Galli, A; Garrone, O; Levaggi, A; Restuccia, E; Saracchini, S; Scalamogna, R; Turazza, M, 2013
)
0.6
"The protease inhibitor bortezomib attenuates the action of NF-κB and has shown preclinical activity alone and in combination with chemotherapy."( A phase I trial of bortezomib in combination with epirubicin, carboplatin and capecitabine (ECarboX) in advanced oesophagogastric adenocarcinoma.
Eatock, MM; Gallagher, R; James, CR; Law, D; Millar, J; Morris, M; Napier, E; Purcell, C; Turkington, RC; Wilson, RH, 2014
)
0.66
"6 mg m(-2) on days 1 and 8 from cycle 2 onwards) in combination with Epirubicin 50 mg m(-2) intravenously on day 1, Carboplatin AUC 5 day 1 and Capecitabine 625 mg m(-2) BD days 1-21 every 21 days (VECarboX regimen), in patients with advanced oesophagogastric adenocarcinoma."( A phase I trial of bortezomib in combination with epirubicin, carboplatin and capecitabine (ECarboX) in advanced oesophagogastric adenocarcinoma.
Eatock, MM; Gallagher, R; James, CR; Law, D; Millar, J; Morris, M; Napier, E; Purcell, C; Turkington, RC; Wilson, RH, 2014
)
0.89
"Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer."( Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA).
Chia, S; Cortés, J; Eniu, A; Harvey, V; Hegg, R; Hickish, T; McNally, V; Ratnayake, J; Ross, G; Schneeweiss, A; Seo, JH; Tausch, C; Tsai, YF, 2013
)
0.39
"To compare the effect of radiofrequency ablation (RFA) combined with transcatheter arterial chemoembolization (TACE) with radiofrequency ablation alone for the treatment of 3 - 5 cm hepatocellular carcinoma (HCC)."( [Clinical outcomes of radiofrequency ablation combined with transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma: a single-center experience].
Bao, LW; Jiang, XF; Jin, XJ; Lin, JJ; Lu, LJ; Wu, W, 2013
)
0.39
"From January 2006 to March 2010, sixty-two HCC patients were randomly treated with RFA combined with TACE (n = 32) or RFA alone (n = 30)."( [Clinical outcomes of radiofrequency ablation combined with transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma: a single-center experience].
Bao, LW; Jiang, XF; Jin, XJ; Lin, JJ; Lu, LJ; Wu, W, 2013
)
0.39
"The role of aromatase inhibitors combined with gonadotropin-releasing hormone analog in metastatic male breast cancer patients remains unknown."( Letrozole combined with gonadotropin-releasing hormone analog for metastatic male breast cancer.
Barba, M; Del Medico, P; Di Lauro, L; Giannarelli, D; Laudadio, L; Maugeri-Saccà, M; Pizzuti, L; Sergi, D; Tomao, S; Vici, P, 2013
)
0.39
"GLS combined with cTnT may provide a reliable and non-invasive method to predict cardiac dysfunction in patients receiving anthracycline-based chemotherapy."( Two-dimensional speckle tracking echocardiography combined with high-sensitive cardiac troponin T in early detection and prediction of cardiotoxicity during epirubicine-based chemotherapy.
Chen, H; Cheng, L; Kang, Y; Li, L; Pan, C; Shu, X; Sun, M; Xu, X, 2014
)
0.6
"To investigate the effect of low-dose carvedilol combined with candesartan in the prevention of acute and chronic cardiotoxicity of anthracycline drugs in adjuvant chemotherapy of breast cancer."( [Preventive effect of low-dose carvedilol combined with candesartan on the cardiotoxicity of anthracycline drugs in the adjuvant chemotherapy of breast cancer].
Han, YL; Liang, XF; Liu, L; Liu, YY; Liu, ZZ; Xie, XD; Zheng, ZD, 2013
)
0.39
"Forty patients were randomly divided into two groups: the experimental group with chemotherapy plus low-dose carvedilol combined with candesartan (20 cases) and control group with chemotherapy alone (20 cases)."( [Preventive effect of low-dose carvedilol combined with candesartan on the cardiotoxicity of anthracycline drugs in the adjuvant chemotherapy of breast cancer].
Han, YL; Liang, XF; Liu, L; Liu, YY; Liu, ZZ; Xie, XD; Zheng, ZD, 2013
)
0.39
"The use of low-dose carvedilol combined with candesartan can reduce the acute and chronic cardiotoxicity of anthracycline drugs, and with tolerable toxicities."( [Preventive effect of low-dose carvedilol combined with candesartan on the cardiotoxicity of anthracycline drugs in the adjuvant chemotherapy of breast cancer].
Han, YL; Liang, XF; Liu, L; Liu, YY; Liu, ZZ; Xie, XD; Zheng, ZD, 2013
)
0.39
" We conducted a phase I study combining VFL with epirubicin (EPR) to establish the recommended dose (RD), to evaluate the safety and efficacy profiles and to investigate potential pharmacokinetic (PK) drug-drug interaction (DDI)."( A phase I clinical and pharmacokinetic study evaluating vinflunine in combination with epirubicin as first-line treatment in metastatic breast cancer.
Bostnavaron, M; Campone, M; Chan, S; Conte, PF; Nguyen, L; Santoro, A, 2014
)
0.88
" Epirubicin, a doxorubicin analogue, may be administered alone or in combination with other agents to treat primary liver cancer and metastatic diseases."( Schedule-dependent effects of kappa-selenocarrageenan in combination with epirubicin on hepatocellular carcinoma.
Chen, N; Ji, YB; Li, WL; Ling, N; Mao, YX; Zhou, XJ, 2014
)
1.54
"To investigate the electronic anti-nausea instrument (EANI) combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy."( Phase II study on EANI combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy.
Guo, JX; Huang, XE; Liu, J; Liu, YC; Wei, W; Xiao, Y, 2014
)
0.4
"Patients who received highly emetogenic chemotherapy were randomly assigned to a treatment group (60 patients) treated with EANI combined with hydrochloride palonosetron, and control group (also 60 patients) given only hydrochloride palonosetron."( Phase II study on EANI combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy.
Guo, JX; Huang, XE; Liu, J; Liu, YC; Wei, W; Xiao, Y, 2014
)
0.4
"EANI combined with hydrochloride palonosetron for prevention of nausea and vomiting induced by chemotherapy could be more effective than hydrochloride palonosetron alone, and can be recommended for use in prevention and treatment of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy."( Phase II study on EANI combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy.
Guo, JX; Huang, XE; Liu, J; Liu, YC; Wei, W; Xiao, Y, 2014
)
0.4
" We aimed to assess the safety, efficacy, biomarkers, and pharmacokinetics of rilotumumab combined with epirubicin, cisplatin, and capecitabine (ECX) in patients with advanced gastric or oesophagogastric junction cancer."( Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study.
Anderson, A; Davidenko, I; Deptala, A; Donehower, RC; Dubey, S; Harrison, M; Iveson, T; Jiang, Y; Lakshmaiah, K; Loh, E; Nirni, S; Oliner, KS; Tang, R; Thomas, A; Tjulandin, S; Zhu, M, 2014
)
0.9
"To assess side effects on Cantharidin sodium and Shenmai injection combined with chemotherapy in treating patients with breast cancer postoperatively."( Clinical study on safety of cantharidin sodium and shenmai injection combined with chemotherapy in treating patients with breast cancer postoperatively.
Cao, J; Huang, XE; Wang, L, 2014
)
0.4
"Patients with breast cancer receiving postoperative chemotherapy were retrospectively collected, and divided into four groups: group A with cantharidin sodium injection combined with chemotherapy; group B with Shenmai injection combined with chemotherapy; group C with both cantharidin sodium and Shenmai injection combined with chemotherapy; while group D (control group) received chemotherapy alone."( Clinical study on safety of cantharidin sodium and shenmai injection combined with chemotherapy in treating patients with breast cancer postoperatively.
Cao, J; Huang, XE; Wang, L, 2014
)
0.4
"Thus cantharidin sodium and Shenmai injection combined with chemotherapy reduce side effects and deserve to be further investigated in randomized clinical control trials."( Clinical study on safety of cantharidin sodium and shenmai injection combined with chemotherapy in treating patients with breast cancer postoperatively.
Cao, J; Huang, XE; Wang, L, 2014
)
0.4
"The aim of this paper was to evaluate the activity and tolerability of weekly docetaxel (D) combined with weekly epirubicin (EPI) in patients with advanced castrate-resistant prostate cancer (CRPC) previously exposed to D and abiraterone acetate (AA)."( Rechallenge of docetaxel combined with epirubicin given on a weekly schedule in advanced castration-resistant prostate cancer patients previously exposed to docetaxel and abiraterone acetate: a single-institution experience.
Barbanti, G; Bianco, V; Brozzetti, S; De Rubertis, G; Fiaschi, AI; Francini, E; Laera, L; Miano, ST; Petrioli, R; Roviello, G, 2015
)
0.9
" This study was performed to examine the efficacy, toxicity, and tolerability of pirarubicin (THP) and epirubicin (EPI) in combination with docetaxel and cyclophosphamide in a NACT setting for BC."( Neoadjuvant chemotherapy of breast cancer with pirarubicin versus epirubicin in combination with cyclophosphamide and docetaxel.
Gu, X; Jia, S; Wei, W; Zhang, WH, 2015
)
0.87
" The aim of this retrospective study was to evaluate the activity and toxicity of bevacizumab combined with chemotherapy in the treatment of recurrence or platinum-refractory ovarian cancer."( Bevacizumab combined with chemotherapy in the treatment of recurrence or platinum-refractory ovarian cancer: a retrospective study of 37 cases.
Li, Y; Shang, YM; Yang, Y; Zheng, H, 2014
)
0.4
"Totally, 37 ovarian cancer patients with complete data who treated with bevacizumab combined with chemotherapy were reviewed from the databases of Beijing Cancer hospital and included in this retrospective study."( Bevacizumab combined with chemotherapy in the treatment of recurrence or platinum-refractory ovarian cancer: a retrospective study of 37 cases.
Li, Y; Shang, YM; Yang, Y; Zheng, H, 2014
)
0.4
"Adjuvant trastuzumab in combination with chemotherapy improves survival of women with HER2-positive early breast cancer."( Six versus 12 months of adjuvant trastuzumab in combination with dose-dense chemotherapy for women with HER2-positive breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG).
Boukovinas, I; Georgoulias, V; Kakolyris, S; Kentepozidis, N; Malamos, N; Mavroudis, D; Papakotoulas, P; Saloustros, E; Ziras, N, 2015
)
0.42
" CDK1/CDK2 inhibitors, such as dinaciclib, combined with anthracyclines, were synergistic in decreasing viability of TNBC cell lines."( A phase 1 study with dose expansion of the CDK inhibitor dinaciclib (SCH 727965) in combination with epirubicin in patients with metastatic triple negative breast cancer.
Alvarez, R; Briones, B; Ibrahim, N; Karakas, C; Keyomarsi, K; Mitri, Z; Moulder, S; Murray, JL; Simmons, H; Wei, C, 2015
)
0.63
" EPI-MBs+mAb combined with therapeutic ultrasound significantly promoted the MM CSC apoptosis compared with EPI, EPI-MBs alone or EPI-MBs+mAb without ultrasound exposure."( Inhibitory effect of epirubicin-loaded lipid microbubbles with conjugated anti-ABCG2 antibody combined with therapeutic ultrasound on multiple myeloma cancer stem cells.
Di, W; Dou, J; Gu, N; He, X; Li, M; Shi, F; Wu, S; Yang, F; Zhang, Y, 2016
)
0.75
" Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41."( Safety Analysis of Adjuvant Chemotherapy with Docetaxel Administered with or without Anthracyclines to Early Stage Breast Cancer Patients: Combined Results from the Asia- Pacific Breast Initiatives I and II.
Ba, DN; Chao, TY; Hou, MF; Kim, SB; Sayeed, A; Shah, MA; Shen, ZZ; Thuan, TV; Villalon, AH; Yau, TK, 2016
)
0.43
" In this study, we investigated the anticancer activity of Paeonol in combination with Epirubicin against breast cancer and the alleviated effect of Paeonol on cardiotoxicity induced by Epirubicin."( Enhanced antitumor activity and attenuated cardiotoxicity of Epirubicin combined with Paeonol against breast cancer.
Cao, H; Guo, R; Jiang, W; Kong, F; Li, J; Sun, D; Wu, J; Xue, X; Zhang, B, 2016
)
0.9
"EndoTAG-1, a tumor endothelial targeting agent has shown activity in metastatic triple-negative breast cancer (BC) in combination with paclitaxel."( Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer.
Ameye, L; Awada, A; Bustin, F; D'Hondt, V; Dal Lago, L; De Azambuja, E; Gombos, A; Ignatiadis, M; Larsimont, D; Lebrun, F; Lemort, M; Maetens, M; Michiels, S; Nogaret, JM; Paesmans, M; Piccart, M; Sotiriou, C; Vanderbeeken, MC; Veys, I; Wilke, C; Zardavas, D, 2016
)
0.43
"We present a pooled analysis of predictive and prognostic values of circulating tumour cells (CTC) and circulating endothelial cells (CEC) in two prospective trials of patients with inflammatory breast cancer (IBC) treated with neoadjuvant chemotherapy combined with neoadjuvant and adjuvant bevacizumab."( Circulating tumour cells and pathological complete response: independent prognostic factors in inflammatory breast cancer in a pooled analysis of two multicentre phase II trials (BEVERLY-1 and -2) of neoadjuvant chemotherapy combined with bevacizumab.
Andre, F; Autret, A; Bachelot, T; Bertucci, F; Bidard, FC; Boher, JM; Bonneterre, J; Campone, M; Charafe-Jaufret, E; Dalenc, F; Eymard, JC; Ferrero, JM; Gligorov, J; Hardy-Bessard, AC; Kerbrat, P; Lemonnier, J; Lerebours, F; Levy, C; Lortholary, A; Mouret-Reynier, MA; Petit, T; Pierga, JY; Proudhon, C; Romieu, G; Soulie, P; Viens, P, 2017
)
0.46
"Nonmetastatic T4d patients were enrolled in two phase II multicentre trials, evaluating bevacizumab in combination with sequential neoadjuvant chemotherapy of four cycles of FEC followed by four cycles of docetaxel in HER2-negative tumour (BEVERLY-1) or docetaxel and trastuzumab in HER2-positive tumour (BEVERLY-2)."( Circulating tumour cells and pathological complete response: independent prognostic factors in inflammatory breast cancer in a pooled analysis of two multicentre phase II trials (BEVERLY-1 and -2) of neoadjuvant chemotherapy combined with bevacizumab.
Andre, F; Autret, A; Bachelot, T; Bertucci, F; Bidard, FC; Boher, JM; Bonneterre, J; Campone, M; Charafe-Jaufret, E; Dalenc, F; Eymard, JC; Ferrero, JM; Gligorov, J; Hardy-Bessard, AC; Kerbrat, P; Lemonnier, J; Lerebours, F; Levy, C; Lortholary, A; Mouret-Reynier, MA; Petit, T; Pierga, JY; Proudhon, C; Romieu, G; Soulie, P; Viens, P, 2017
)
0.46
"This study evaluated safety, pharmacokinetics, and clinical activity of intravenous and oral rucaparib, a poly(ADP-ribose) polymerase inhibitor, combined with chemotherapy in patients with advanced solid tumours."( A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours.
Dieras, V; Evans, TJ; Giordano, H; Goble, S; Jaw-Tsai, S; Middleton, MR; Molife, LR; Plummer, R; Roxburgh, P; Spicer, J; Wilson, RH, 2017
)
0.46
"Initially, patients received escalating doses of intravenous rucaparib combined with carboplatin, carboplatin/paclitaxel, cisplatin/pemetrexed, or epirubicin/cyclophosphamide."( A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours.
Dieras, V; Evans, TJ; Giordano, H; Goble, S; Jaw-Tsai, S; Middleton, MR; Molife, LR; Plummer, R; Roxburgh, P; Spicer, J; Wilson, RH, 2017
)
0.65
"Oral rucaparib can be safely combined with a clinically relevant dose of carboplatin in patients with advanced solid tumours (Trial registration ID: NCT01009190)."( A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours.
Dieras, V; Evans, TJ; Giordano, H; Goble, S; Jaw-Tsai, S; Middleton, MR; Molife, LR; Plummer, R; Roxburgh, P; Spicer, J; Wilson, RH, 2017
)
0.46
" The aim of this study is to evaluate the synergistic anti-tumor effects and underlying mechanism of κ-selenocarrageenan (KSC) in combination with the chemotherapy drug epirubicin (EPI) in H22 tumor-bearing mice."( Immuno-modulatory and cellular antioxidant activities of κ-selenocarrageenan in combination with Epirubicin in H22 hepatoma-bearing mice.
Ji, C; Ji, Y; Li, W; Ling, N; Qi, Z; Zhou, X, 2017
)
0.87
" To discuss the effects of oxaliplatin in combination with epirubicin in the treatment and its influence on prognosis, this study randomly selected 218 advanced primary liver carcinoma patients from Binzhou People’s Hospital, Binzhou, China and divided them into a control group (n=109) and an observation group (n=109)."( Application of oxaliplatin in combination with epirubicin in transcatheter arterial chemoembolization in the treatment of primary liver carcinoma.
Chang, G; Huang, PC; Li, HF; Li, WY; Liu, QR; Xia, FF; Xie, LL; Zhang, CD; Zhang, TJ,
)
0.63
" All of our results confirmed that terfenadine combined with EPI synergistically inhibits the growth and metastatic processes of resistant cells both in vitro and in vivo."( Terfenadine combined with epirubicin impedes the chemo-resistant human non-small cell lung cancer both in vitro and in vivo through EMT and Notch reversal.
An, L; Chu, HX; Fan, YH; Feng, F; Li, DD; Ma, HD; Song, Q; Wang, CL; Zhang, Q; Zhao, QC, 2017
)
0.76
"The patient was treated with apatinib combined with epirubicin."( Successful treatment of ovarian cancer with apatinib combined with chemotherapy: A case report.
Sun, Y; Tian, Z; Zhang, M, 2017
)
0.71
"Apatinib combined with chemotherapy and apatinib monotherapy as maintenance therapy could be a new therapeutic strategy for ovarian cancer, especially adenocarcinomas."( Successful treatment of ovarian cancer with apatinib combined with chemotherapy: A case report.
Sun, Y; Tian, Z; Zhang, M, 2017
)
0.46
"To assess the efficacy of intra-arterial chemotherapy (IAC) combined with intravesical chemotherapy (IVC) in T1G3 bladder cancer (Bca) after transurethral resection of bladder tumor (TURBT)."( Efficacy of intra-arterial chemotherapy combined with intravesical chemotherapy in T1G3 bladder cancer when compared with intravesical chemotherapy alone after bladder-sparing surgery: a retrospective study.
Chen, J; Chen, L; Fan, W; Huang, B; Qiu, S; Yao, Z; Zheng, J, 2019
)
0.51
" The patients' medical records were divided into two groups, one group only had IVC with pirarubicin after surgery, and the other group had IAC (cisplatin and epirubicin) combined with IVC after surgery."( Efficacy of intra-arterial chemotherapy combined with intravesical chemotherapy in T1G3 bladder cancer when compared with intravesical chemotherapy alone after bladder-sparing surgery: a retrospective study.
Chen, J; Chen, L; Fan, W; Huang, B; Qiu, S; Yao, Z; Zheng, J, 2019
)
0.71
"T1G3 BCa post-TURBT surgery patients who underwent IAC combined with IVC had a longer overall survival and increased time interval to first recurrence, lower tumor recurrence rate, progression rate and tumor-specific death rate than compared with those who only underwent IVC alone."( Efficacy of intra-arterial chemotherapy combined with intravesical chemotherapy in T1G3 bladder cancer when compared with intravesical chemotherapy alone after bladder-sparing surgery: a retrospective study.
Chen, J; Chen, L; Fan, W; Huang, B; Qiu, S; Yao, Z; Zheng, J, 2019
)
0.51
"Comparing intra-arterial chemotherapy combined with intravesical chemotherapy against intravesical chemotherapy alone in the treatment of T1-staged Grade 3 (T1G3) bladder cancer after transurethral resection of bladder tumor (TURBT)."( Evaluation of the effects of intra-arterial chemotherapy combined with intravesical chemotherapy against intravesical chemotherapy alone after transurethral resection of bladder tumor in T1-staged Grade 3 bladder cancer.
Chen, J; Chen, L; Fan, W; Huang, B; Lin, H; Qiu, S; Wang, H; Yao, Z; Zheng, J, 2019
)
0.51
"From January 2007 to December 2012, 203 patients diagnosed with NMIBC were randomly assigned into either intra-arterial chemotherapy combined with intravesical chemotherapy group (Group A, n = 68) or intravesical chemotherapy alone group (Group B, n = 135) after TURBT."( Evaluation of the effects of intra-arterial chemotherapy combined with intravesical chemotherapy against intravesical chemotherapy alone after transurethral resection of bladder tumor in T1-staged Grade 3 bladder cancer.
Chen, J; Chen, L; Fan, W; Huang, B; Lin, H; Qiu, S; Wang, H; Yao, Z; Zheng, J, 2019
)
0.51
"Intra-arterial chemotherapy combined with intravesical chemotherapy could reduce the risk of recurrence and progression compared to intravesical chemotherapy alone in T1G3 bladder cancer."( Evaluation of the effects of intra-arterial chemotherapy combined with intravesical chemotherapy against intravesical chemotherapy alone after transurethral resection of bladder tumor in T1-staged Grade 3 bladder cancer.
Chen, J; Chen, L; Fan, W; Huang, B; Lin, H; Qiu, S; Wang, H; Yao, Z; Zheng, J, 2019
)
0.51
"To evaluate the efficacy and safety of intra-arterial chemotherapy (IAC) combined with intravesical chemotherapy (IC) in non-muscle invasive bladder cancer (NMIBC) and identify the risk factors for recurrence and progression."( Intra-arterial chemotherapy combined with intravesical chemotherapy is effective in preventing recurrence in non-muscle invasive bladder cancer.
Chen, W; Cui, W; Fan, W; Li, J; Lian, F; Liu, Y; Shen, L; Wang, Y; Zhao, Y, 2019
)
0.51
" Ninety-nine patients underwent IAC combined with transurethral resection of bladder tumor (TURBT) and IC, and 50 patients underwent TURBT plus IC without IAC."( Intra-arterial chemotherapy combined with intravesical chemotherapy is effective in preventing recurrence in non-muscle invasive bladder cancer.
Chen, W; Cui, W; Fan, W; Li, J; Lian, F; Liu, Y; Shen, L; Wang, Y; Zhao, Y, 2019
)
0.51
"To investigate the therapeutic effects of menstrual blood derived mesenchymal stem cells (MB-MSCs) combined with Bushen Tiaochong recipe (BSTCR) on epirubicin induced premature ovarian failure (POF) in mice."( Menstrual blood derived mesenchymal stem cells combined with Bushen Tiaochong recipe improved chemotherapy-induced premature ovarian failure in mice by inhibiting GADD45b expression in the cell cycle pathway.
Du, X; Guo, F; Han, Y; Hao, S; Ma, R; Ma, X; Xia, T; Yan, Z; Zhang, Y; Zhou, Y, 2019
)
0.71
"Twenty-four female C57BL/6 mice of 6-8 weeks were intraperitoneally injected with epirubicin to induce POF, and then they were randomized into 4 groups of 6 mice each and treated with PBS, MB-MSCs, BSTCR, and MB-MSCs combined with BSTCR, respectively."( Menstrual blood derived mesenchymal stem cells combined with Bushen Tiaochong recipe improved chemotherapy-induced premature ovarian failure in mice by inhibiting GADD45b expression in the cell cycle pathway.
Du, X; Guo, F; Han, Y; Hao, S; Ma, R; Ma, X; Xia, T; Yan, Z; Zhang, Y; Zhou, Y, 2019
)
0.74
" However, MB-MSCs combined with BSTCR rescued epirubicin induced POF through down-regulating GADD45b and pCDC2 expressions, and up-regulating CyclinB1 and CDC2 expressions."( Menstrual blood derived mesenchymal stem cells combined with Bushen Tiaochong recipe improved chemotherapy-induced premature ovarian failure in mice by inhibiting GADD45b expression in the cell cycle pathway.
Du, X; Guo, F; Han, Y; Hao, S; Ma, R; Ma, X; Xia, T; Yan, Z; Zhang, Y; Zhou, Y, 2019
)
0.77
"MB-MSCs combined with BSTCR improved the ovarian function of epirubicin induced POF mice, which might be related to the inhibition of GADD45b expression and the promotion of CyclinB1 and CDC2 expressions."( Menstrual blood derived mesenchymal stem cells combined with Bushen Tiaochong recipe improved chemotherapy-induced premature ovarian failure in mice by inhibiting GADD45b expression in the cell cycle pathway.
Du, X; Guo, F; Han, Y; Hao, S; Ma, R; Ma, X; Xia, T; Yan, Z; Zhang, Y; Zhou, Y, 2019
)
0.76
"To investigate the efficacy and safety of transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin within 24 hours postoperatively for treatment of non-muscular invasive bladder cancer."( Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin within 24 hours postoperatively for treatment of bladder cancer.
Gu, H; Hou, J; Liu, H; Lu, J; Miao, H; Shen, F; Xue, Y, 2020
)
0.97
"THOLR and TUR combined with intravesical epirubicin within 24 hours postoperatively were both safe and effective for treatment of bladder tumor; however, patients who undergo THOLR might experience more rapid recovery."( Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin within 24 hours postoperatively for treatment of bladder cancer.
Gu, H; Hou, J; Liu, H; Lu, J; Miao, H; Shen, F; Xue, Y, 2020
)
1.04
"To investigate whether palonosetron is better than granisetron in preventing chemotherapy-induced nausea and vomiting (CINV) in a three-drug combination with dexamethasone and fosaprepitant (Fos) in patients with breast cancer who are placed on anthracycline and cyclophosphamide (AC-based regimen)."( A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophospham
Aogi, K; Baba, M; Chiba, Y; Fujiwara, K; Hirano, G; Imamura, CK; Imoto, S; Matsumoto, K; Matsuura, K; Miyazaki, C; Naito, Y; Osaki, A; Saeki, T; Sato, K; Takahashi, M; Takano, T; Tamura, K; Tokunaga, S; Yanagihara, K, 2020
)
0.56
"75 mg (day 1) or granisetron 1 mg (day 1) combined with dexamethasone (12 mg at day 1, 8 mg at day 2 and day 3) and Fos 150 mg (day 1) before receiving AC-based regimen in a double-blind study."( A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophospham
Aogi, K; Baba, M; Chiba, Y; Fujiwara, K; Hirano, G; Imamura, CK; Imoto, S; Matsumoto, K; Matsuura, K; Miyazaki, C; Naito, Y; Osaki, A; Saeki, T; Sato, K; Takahashi, M; Takano, T; Tamura, K; Tokunaga, S; Yanagihara, K, 2020
)
0.56
"In combination with dexamethasone and Fos, this study suggests that palonosetron is not better than granisetron in chemo-naive patients with primary breast cancer receiving AC-based regimen."( A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophospham
Aogi, K; Baba, M; Chiba, Y; Fujiwara, K; Hirano, G; Imamura, CK; Imoto, S; Matsumoto, K; Matsuura, K; Miyazaki, C; Naito, Y; Osaki, A; Saeki, T; Sato, K; Takahashi, M; Takano, T; Tamura, K; Tokunaga, S; Yanagihara, K, 2020
)
0.56
"High-dose anlotinib combined with epirubicin was an effective and safe therapy for STS."( Efficacy and safety of anlotinib, a multikinase angiogenesis inhibitor, in combination with epirubicin in preclinical models of soft tissue sarcoma.
Guo, X; Lu, WQ; Tong, HX; Wang, ZM; Yang, H; Zhang, SL; Zhang, Y; Zhou, YH; Zhuang, RY, 2020
)
1.06
"To evaluate the anti-cancer effect of epirubicin combined with BCG on human bladder cancer cells, our studies were carried out."( The Apoptosis Mechanism of Epirubicin Combined with BCG on Human Bladder Cancer Cells.
Dong, B; Fu, X; Han, B; Luo, Y; Men, H; Meng, M; Tian, S; Yuan, L; Zhang, F; Zhang, S, 2020
)
1.13
"The viability of human bladder cancer with epirubicin or BCG treatment was decreased and the viability with epirubicin combined with BCG treatment was decreased more, which were determined by CCK-8 assay."( The Apoptosis Mechanism of Epirubicin Combined with BCG on Human Bladder Cancer Cells.
Dong, B; Fu, X; Han, B; Luo, Y; Men, H; Meng, M; Tian, S; Yuan, L; Zhang, F; Zhang, S, 2020
)
1.12
" In the current study, we aimed to investigate the apoptotic and anti-cancer effect of Parthenolide in combination with Epirubicin in the MDA-MB-468 breast cancer cell line."( Anticancer and apoptotic activities of parthenolide in combination with epirubicin in mda-mb-468 breast cancer cells.
Ghorbani-Abdi-Saedabad, A; Hanafi-Bojd, MY; Hoshyar, R; Mollaei, H; Parsamanesh, N; Tayarani-Najaran, Z, 2020
)
1
"To compare the efficacy and safety of etoposide combined with lobaplatin or cisplatin in the first-line treatment of extensive-stage small cell lung cancer (SCLC)."( A comparative study on etoposide combined with lobaplatin or cisplatin in the first-line treatment of extensive-stage small cell lung cancer.
Chen, H; Huang, Z; Li, S; Liang, Y; Lin, Y; Wu, A; Wu, Y; Yang, Z,
)
0.13
" The purpose of this study was to evaluate the safety and efficacy of TACE combined with sorafenib (TACE-sorafenib) and TACE alone for the treatment of Barcelona clinical stage C HCC."( Transarterial Chemoembolization Combined with Sorafenib in Patients with BCLC Stage C Hepatocellular Carcinoma.
Cheng, DL; Gao, ZG; Hao, YH; Ji, CS; Jia, WD; Liu, KC; Lv, WF; Shi, CS; Su, MX; Xu, SB; Zhou, CZ, 2020
)
0.56
"Compared with TACE treatment alone, TACE combined with sorafenib in BCLC-C stage HCC significantly improved disease control rate, TTP, and OS, and no significant increase in adverse reactions was observed."( Transarterial Chemoembolization Combined with Sorafenib in Patients with BCLC Stage C Hepatocellular Carcinoma.
Cheng, DL; Gao, ZG; Hao, YH; Ji, CS; Jia, WD; Liu, KC; Lv, WF; Shi, CS; Su, MX; Xu, SB; Zhou, CZ, 2020
)
0.56
" In this study, we administered apatinib in combination with chemotherapy to achieve good disease control."( Chemotherapy combined with apatinib for the treatment of desmoplastic small round cell tumors: A case report.
Cheng, X; Li, Y; Tian, Y, 2020
)
0.56
"To compare the efficacy and safety of intra-arterial chemotherapy (IAC) combined with intravesical chemotherapy (IVC) against intravesical BCG immunotherapy in high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of the bladder tumor (TURBT)."( Intra-arterial chemotherapy combined with intravesical chemotherapy compared with intravesical BCG immunotherapy retrospectively in high-risk non-muscle-invasive bladder cancer after transurethral resection of the bladder tumor.
Chen, J; Chen, L; Huang, B; Huang, G; Li, W; Mao, X, 2021
)
0.62
"130 patients with high-risk NMIBC who had underwent TURBT were divided into two groups, of which IAC + IVC group received four courses of IAC (cisplatin and epirubicin) combined with IVC (epirubicin or pirarubicin) after surgery and BCG group received intravesical BCG immunotherapy."( Intra-arterial chemotherapy combined with intravesical chemotherapy compared with intravesical BCG immunotherapy retrospectively in high-risk non-muscle-invasive bladder cancer after transurethral resection of the bladder tumor.
Chen, J; Chen, L; Huang, B; Huang, G; Li, W; Mao, X, 2021
)
0.82
"IAC combined with IVC used in high-risk NMIBC could reduce the recurrence and progression as effective as BCG instillation with lower adverse events."( Intra-arterial chemotherapy combined with intravesical chemotherapy compared with intravesical BCG immunotherapy retrospectively in high-risk non-muscle-invasive bladder cancer after transurethral resection of the bladder tumor.
Chen, J; Chen, L; Huang, B; Huang, G; Li, W; Mao, X, 2021
)
0.62
"To investigate the value of contrast-enhanced computed tomography (CECT) radiomics features in predicting the efficacy of epirubicin combined with ifosfamide in patients with pulmonary metastases from soft tissue sarcoma."( Prediction of the therapeutic efficacy of epirubicin combined with ifosfamide in patients with lung metastases from soft tissue sarcoma based on contrast-enhanced CT radiomics features.
Jiang, X; Li, M; Ma, ST; Miao, L; Wang, YM; Zhang, HH, 2022
)
1.19
"A retrospective analysis of 51 patients with pulmonary metastases from soft tissue sarcoma who received the chemotherapy regimen of epirubicin combined with ifosfamide was performed, and efficacy was evaluated by Recist1."( Prediction of the therapeutic efficacy of epirubicin combined with ifosfamide in patients with lung metastases from soft tissue sarcoma based on contrast-enhanced CT radiomics features.
Jiang, X; Li, M; Ma, ST; Miao, L; Wang, YM; Zhang, HH, 2022
)
1.19
"Pembrolizumab is approved for the neoadjuvant/adjuvant treatment of early triple-negative breast cancer (TNBC) patients in combination with chemotherapy."( Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041).
Belleville, E; Brucker, SY; Erber, R; Fasching, PA; Fehm, TN; Häberle, L; Hack, CC; Hartkopf, AD; Hartmann, A; Hein, A; Janni, W; Kolberg, HC; Rübner, M; Theuser, AK; Uhrig, S; Untch, M, 2023
)
0.91
" Pembrolizumab was given three-weekly in combination with these chemotherapies."( Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041).
Belleville, E; Brucker, SY; Erber, R; Fasching, PA; Fehm, TN; Häberle, L; Hack, CC; Hartkopf, AD; Hartmann, A; Hein, A; Janni, W; Kolberg, HC; Rübner, M; Theuser, AK; Uhrig, S; Untch, M, 2023
)
0.91
"pCR rates after NACT with nP and anthracycline combined with pembrolizumab are encouraging."( Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041).
Belleville, E; Brucker, SY; Erber, R; Fasching, PA; Fehm, TN; Häberle, L; Hack, CC; Hartkopf, AD; Hartmann, A; Hein, A; Janni, W; Kolberg, HC; Rübner, M; Theuser, AK; Uhrig, S; Untch, M, 2023
)
0.91
"This is a retrospective, single-center PSM study evaluating the efficacy and safety of chidamide combined with the CHOEP (C-CHOEP) regimen versus the single CHOEP regimen in patients with untreated peripheral T cell lymphomas (PTCL)."( Long-time follow-up of patients with untreated peripheral T cell lymphoma following chidamide combined with cyclophosphamide, epirubicin, vindesine, prednisone, and etoposide therapy: a single-center propensity score-matching study.
Wang, W; Wei, C; Zhang, W; Zhang, Y; Zhao, D; Zhou, D, 2023
)
1.12

Bioavailability

Epirubicin (EPI) elicits poor-oral bioavailability hence commercially available as injection for intravenous administration. Present investigation is aimed at the development of poly-lactic-co-glycolic acid (PLGA) nanoparticles (NPs) for oral bioavailability enhancement.

ExcerptReferenceRelevance
" Difference in bioavailability in the general circulation between the 2 routes of administration also suggests a certain degree of liver first-pass metabolism of the drug."( Pharmacokinetics of epirubicin emulsion and solution in rabbits after intrahepato-arterial and intravenous injection.
Chan, K; Lee, K, 1992
)
0.61
" However, when data relative to single patients were examined, a trend toward nonlinear drug distribution as well as a consequent increase in peripheral bioavailability could be observed in 4/6 patients of the 75-mg/m2 vs the 150-mg/m2 group."( Epirubicin metabolism and pharmacokinetics after conventional- and high-dose intravenous administration: a cross-over study.
Camaggi, CM; Carisi, P; Martoni, A; Melotti, B; Pannuti, F; Strocchi, E, 1993
)
1.73
" Inhibition of intestinal P-gp function using MDR reversing agents may enhance the oral bioavailability of some chemotherapeutic agents."( Comparison of effects of surfactants with other MDR reversing agents on intracellular uptake of epirubicin in Caco-2 cell line.
Hsu, CY; Huang, JD; Lo, YL,
)
0.35
" This provides a potential strategy for improving bioavailability in the optimization of formulations for drugs performing intestinal absorption and secretion."( Relationships between the hydrophilic-lipophilic balance values of pharmaceutical excipients and their multidrug resistance modulating effect in Caco-2 cells and rat intestines.
Lo, YL, 2003
)
0.32
" EPI-PEG-(NO)8 showed increased bioavailability in mice compared to free EPI."( Polymer-drug conjugates for combination anticancer therapy: investigating the mechanism of action.
Fante, C; Greco, F; Green, RJ; Mendichi, R; Mero, A; Pasut, G; Veronese, FM, 2009
)
0.35
" All results suggested that PANs were stable, safe, and showed a promising potential on improving the bioavailability of the loaded drug of the encapsulated drug."( Stability and in vivo evaluation of pullulan acetate as a drug nanocarrier.
Chen, H; Chen, HL; Li, L; Li, XM; Liu, LR; Tang, HB; Wang, YS; Zhang, QQ; Zhou, ZM,
)
0.13
" An in vivo pharmacokinetic study using SD rats showed that after oral administration in this formulation, Epi had prolonged half-life, greater area under the curve, and higher relative bioavailability than in an oral Epi solution."( pH-and thermo-sensitive pluronic/poly(acrylic acid) in situ hydrogels for sustained release of an anticancer drug.
Hsu, CY; Lin, HR; Lo, YL, 2013
)
0.39
" An in vivo pharmacokinetic study using SD rats showed that after rectal administration of solid and liquid suppositories, Epi had greater area under the curve and higher relative bioavailability than in a rectal solution."( Evaluation of epirubicin in thermogelling and bioadhesive liquid and solid suppository formulations for rectal administration.
Lin, HR; Lin, Y; Lo, YL, 2013
)
0.75
" Present investigation is aimed at the development of poly-lactic-co-glycolic acid (PLGA) nanoparticles (NPs) for oral bioavailability enhancement of epirubicin."( Biodegradable polymeric nanoparticles for oral delivery of epirubicin: In vitro, ex vivo, and in vivo investigations.
Alam, MA; Iqbal, Z; Panda, AK; Singh, AT; Talegaonkar, S; Tariq, M, 2015
)
0.86
"Epirubicin (EPI) elicits poor-oral bioavailability hence commercially available as injection for intravenous administration which follows a rapid increase and fast decay in plasma drug concentration often needs a frequent dosing that may lead to serious side effects."( Improved oral efficacy of epirubicin through polymeric nanoparticles: pharmacodynamic and toxicological investigations.
Alam, MA; Panda, AK; Singh, AT; Talegaonkar, S; Tariq, M, 2016
)
2.18
"57 folds higher oral bioavailability through EPI-PNPs and EPI-MNPs when compared with EPI-S."( Surface decorated nanoparticles as surrogate carriers for improved transport and absorption of epirubicin across the gastrointestinal tract: Pharmacokinetic and pharmacodynamic investigations.
Alam, MA; Panda, AK; Singh, AT; Talegaonkar, S; Tariq, M, 2016
)
0.65
" Resolving this problem will be significant in improving bioavailability and reducing side effects."( Effect of inhibitors of endocytosis and NF-kB signal pathway on folate-conjugated nanoparticle endocytosis by rat Kupffer cells.
Chen, H; Feng, X; Han, Z; Jia, Y; Li, X; Liu, Q; Liu, X; Tang, H; Wang, A, 2017
)
0.46
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The lower haematological toxicity of epirubicin, as well as the recent introduction of supportive measures such as colony-stimulating factors, has allowed dose-intensification. A positive correlation between increased concentration of the drugs used in this experiment and the increase of the cytostatic effect in the group of tumours sensitive in vitro suggests the necessity of raising the dosage of less toxic epirubs.

ExcerptRelevanceReference
" Haematologic toxicity is greater in the CMF group, requiring more frequent dosage reductions."( Randomized trial of adjuvant chemotherapy for operable breast cancer comparing i.v. CMF to an epirubicin-containing regimen [see comment].
Bonichon, F; Chauvergne, J; Dilhuydy, JM; Durand, M; Mauriac, L, 1992
)
0.5
" The highest percentages were reported in studies using doses of doxorubicin of 60 mg/m2 or higher, with a suggested dose-response correlation."( Doxorubicin (or epidoxorubicin) combined with ifosfamide in the treatment of adult advanced soft tissue sarcomas.
Palumbo, R; Santi, L; Sogno, G; Toma, S; Venturino, A, 1992
)
0.28
" EPVP II is given every 21 days with increased dosage and increased intensity of epirubicin."( Novel combination of epirubicin, bleomycin, vinblastine and prednisone (EBVP II) before radical radiotherapy in localized stages (I-IIIA) of Hodgkin's disease. Early results in 100 consecutive patients. Pierre-et-Marie-Curie Group.
Blanc, CM; David, B; Eghbali, H; Hoerni, B; Orgerie, MB; Rojouan, J; Zittoun, R, 1991
)
0.83
" before chemotherapy followed by twice-daily (12-hourly) oral dosing has good efficacy in the control of emesis in oncology outpatients."( Oral treatment with ondansetron in an outpatient setting.
Dicato, MA, 1991
)
0.28
" Seven patients with primary hepatic carcinoma and twenty with metastatic adenocarcinoma of the colon to the liver received intraarterial hepatic infusion of epidoxorubicin at the dosage of 30 mg weekly."( Intrahepatic epidoxorubicin in metastatic and primary liver tumours: a phase II study.
Bertoglio, S; Civalleri, D; Nobile, MT; Percivale, P; Sertoli, MR; Simoni, G; Spagliardi, E; Torelli, P; Venturini, M; Vidili, MG,
)
0.13
" Epirubicin in this dosage and schedule has no major therapeutic activity in heavily pretreated non-seminomatous testicular cancer."( High dose epirubicin in refractory or relapsed non-seminomatous testicular cancer: a phase II study.
Bokemeyer, C; Burk, K; Dölken, G; Harstrick, A; Poliwoda, H; Schmoll, HJ; Schöber, C; Stahl, M; Wilke, H; Wömpner, CK, 1990
)
1.59
" The dosage used was 15 endovesical instillations of 50 mg in 50 cc sterile water, one instillation a week during the first month followed by once monthly to complete a year."( [Prevention of recurrence of superficial tumors of the bladder with intravesical epirubicin].
Arrabal Martín, M; García Pérez, M; Lancina Martín, JA; Vilches Cocovi, E,
)
0.36
" The advantages of chemoradiotherapy in esophageal cancer could be summarized as follows: higher response rate (60-80%), higher proportion of complete responses (up to 45%), longer remission duration, lower radiation dosage (3,200-4,000 cGy) and consequently better tolerance of treatment (less morbidity)."( Combination of cytostatics and radiation--a new trend in the treatment of inoperable esophageal cancer.
Kolarić, K, 1985
)
0.27
" The patients were irradiated in two opposite thoracic fields (Betatron-Siemens) with a total dosage of 3600-4000 cGy (200 cGy daily, 1000 weekly)."( Combination of 4-epi-doxorubicin and irradiation--a new approach in the treatment of locoregionally advanced inoperable esophageal cancer.
Ban, J; Bistrović, M; Dujmović, I; Kolarić, K; Roth, A, 1986
)
0.27
" In addition, increasing the dosage of epirubicin did not result in an increase in the haematologic toxicity or percent of CR."( Comparison of CHOP-B vs CEOP-B in 'poor prognosis' non-Hodgkin's lymphomas. A randomized trial.
Brandi, M; Calabrese, P; De Lena, M; Lorusso, V; Maiello, E; Marzullo, F; Mazzei, A; Romito, S, 1989
)
0.55
" Morning and afternoon dosing of Epi was not bioequivalent."( Pharmacokinetics of 4' epi-adriamycin after morning and afternoon intravenous administration.
Antila, K; Eksborg, S; Stendahl, U, 1989
)
0.28
" A positive correlation between increased concentration of the drugs used in this experiment and the increase of the cytostatic effect in the group of tumours sensitive in vitro suggests the necessity of raising the dosage of less toxic epirubicin in clinical trials."( [Comparison of the cytotoxic activity of doxorubicin and epirubicin by an in vitro test].
Czownicki, Z; Kilka, C; Rosińska, U,
)
0.56
" Although the total cumulative anthracycline dosage was highest in the arm 2 group, they had the lowest incidence of cardiac toxicity."( A comparative study of doxorubicin and epirubicin in patients with metastatic breast cancer.
Benjamin, RS; Chawla, SP; Ewer, MS; Fraschini, G; Hortobagyi, GN; Kau, SW; Yap, HY, 1989
)
0.55
" The results of the 13 patients receiving the PE regimen were retrospectively compared to those of 24 patients who received the conventional PAC schedule (cisplatin, Adriamycin and cyclophosphamide at a dosage of 50, 50 and 750 mg/m2, respectively)."( Efficacy of adjuvant carboplatin-epirubicin chemotherapy in advanced ovarian cancer after radical surgery.
Lahousen, M; Lehnert, M; Petru, E; Pickel, H; Stettner, H, 1989
)
0.56
" With measures like reducing the dosage, delaying the next cycle, or breaking off the therapy the effective dosage can often not be achieved."( [Reducing the side effects of aggressive chemotherapy (cisplatin and epirubicin) with xenogenic peptides (factor AF2) in patients with hormone refractory metastatic prostate cancer. A prospective, randomized study].
Papadopoulos, I; Wand, H, 1989
)
0.51
" The dosage of both agents were equal, 60 mg/m2 every 3 weeks."( Doxorubicin and epirubicin cardiotoxicity: experimental and clinical aspects.
Bandinelli, M; Bartalucci, S; Ciapini, A; Cini-Neri, G; Neri, B; Pacini, P, 1989
)
0.62
" Dose-response curves were steeper for adriamycin than for epirubicin."( A functional assessment of the relative cardiotoxicity of adriamycin and epirubicin in the rat.
Hopewell, JW; Simmonds, RH; Yeung, TK, 1989
)
0.75
" These results indicated that 4'-epi-ADR given the total dose of 150 mg in a single dosage of 50 mg was the most effective agent in intra-arterial infusion chemotherapy for advanced breast cancer."( [Intra-arterial infusion chemotherapy of advanced breast cancer--effects and side effects of adriamycin, 4'-epi-adriamycin and THP-adriamycin].
Asaishi, K; Hayasaka, H; Mikami, T; Narimatsu, E; Okazaki, A; Okazaki, M; Okazaki, Y; Sato, H; Toda, K; Watanabe, Y, 1989
)
0.28
" Dose-response curves suggested that CsA was a more potent modifying agent than 11-Me-Leu-CsA towards resistant CHRC5 cells."( Enhancement of anthracycline growth inhibition in parent and multidrug-resistant Chinese hamster ovary cells by cyclosporin A and its analogues.
Chambers, SK; Hait, WN; Handschumacher, RE; Kacinski, BM; Keyes, SR, 1989
)
0.28
" The dosage of 4'-epidoxorubicin must, however, be adjusted according to species differences in pharmacokinetics."( Effect of preoperative 4'-epidoxorubicin (epi-adriamycin) treatment on the regeneration and function of the liver in partially hepatectomized rats.
Bergan, A; Clausen, OP; Hall, KS; Lien, B; Paulsen, JE; Rugstad, HE, 1989
)
0.28
" The dosage of 120 mg/m2 was well tolerated."( 4-epidoxorubicin in recurrent cervical cancer.
Choy, DT; Ma, HK; Ngan, HY; Sham, JS; Wong, LC, 1989
)
0.28
" Dosage adjustments are recommended for patients with liver metastases or elevated liver function tests."( Epirubicin: a review of the pharmacology, clinical activity, and adverse effects of an adriamycin analogue.
Cersosimo, RJ; Hong, WK, 1986
)
1.71
" The appropriate dosage of the drug and the interval for infusion are to be elucidated."( [Intra-arterial administration of epirubicin in the treatment of non-resectable hepatocellular carcinoma. Epirubicin Study Group for Hepatocellular Carcinoma].
Ando, K; Hirai, K; Kubo, Y; Kuroda, C; Nagasue, N; Okamura, J; Okita, K; Tamura, K; Tanikawa, K; Yukaya, H, 1986
)
0.55
" EPI was administered intravenously at the dosage of 60 mg/m2 for non-small cell lung cancer (NSCLC) and 75 mg/m2 for small cell lung cancer (SCLC) at the interval of three to four weeks."( [A phase II study of epirubicin in advanced lung cancer].
Arai, R; Fukuoka, M; Furuse, K; Hayashi, S; Kawahara, M; Kiyota, M; Kodama, N; Kubota, K; Tsuruta, M; Yamamoto, M, 1986
)
0.59
" Similar changes were observed with 4'-epi-DX; the dose-response curves indicated that 4'-epi-DX might be slightly, although not significantly, less effective than DX."( Effect of doxorubicin and 4'-epi-doxorubicin on mouse spermatogenesis.
Göhde, W; Hacker-Klom, UB; Meistrich, ML, 1986
)
0.27
" This well-tolerated regimen is active in advanced high-risk elderly breast cancer patients, but dosage might be too low for younger patients and nonpretreated patients."( Preliminary analysis of combined treatment with prednimustine and 4'epidoxorubicin in advanced breast cancer.
Aapro, MS; Alberto, P; Forni, M; Krauer, F; Wählby, S, 1986
)
0.27
" The dosage employed was 60 mg/m2 for EPI and 40 mg/m2 for DX at intervals of three weeks."( [A prospective randomized trial comparing epirubicin and doxorubicin in advanced or recurrent breast cancer].
Izuo, M; Nakajima, M; Ogawa, M; Taguchi, T; Terasawa, T; Yoshida, M, 1986
)
0.54
" Intravenous administration of this new anticancer antibiotic, at a dosage of 60 mg/m2 every three weeks, showed the response rate of 20."( [Cooperative phase II study of epirubicin (EPI) in bladder cancer, renal pelvic and ureteral tumors--Urological Cooperative Study Group of EPI].
Akaza, H; Isaka, S; Ishikawa, H; Koiso, K; Koyanagi, T; Maru, A; Niijima, T; Sakashita, S; Shimazaki, J; Uchida, K, 1986
)
0.56
" The drug was administered at the dosage of 25 mg/m2 weekly."( Phase II trial of weekly 4-epi-doxorubicin (epirubicin) in squamous cell carcinoma of the head and neck.
Bertetto, O; Calciati, A; Clerico, M; Dongiovanni, V, 1987
)
0.53
" The overall toxicity was high, with hematologic, digestive and renal side effects, leading to stop the treatment in 5/25 patients, and to reduce drugs dosage by greater than or equal to 25% in nearly half of the patients."( [Treatment of soft tissue sarcomas in the adult with a combination of vindesine and cisplatin with doxorubicin or epirubicin: a pilot study].
Becouarn, Y; Brunet, R; Bui, BN; Chauvergne, J; Kerbrat, P; Robert, J, 1987
)
0.48
"Thirty-seven cases of superficial bladder cancer were treated with 4'-epi-adriamycin (EPI) by intravesical instillation to investigate the optimal dosage and treatment schedule."( [Intravesical chemotherapy with 4'-EPI-adriamycin in patients with superficial bladder tumors (randomized study)].
Akagi, T; Matsumura, Y; Nasu, Y; Obama, T; Ohmori, H; Ozaki, Y; Tsushima, T, 1985
)
0.27
" With 4'-epidoxorubicin there resulted a higher therapeutic index and therapeutic ratio, permitting the use of higher dosage and a greater margin of safety."( The effectiveness of the anthracycline analog 4'-epidoxorubicin in the treatment of experimental tumors: a review.
Geran, R; Goldin, A; Venditti, JM, 1985
)
0.27
" The dosage was 75 mg/m2/cycle repeated every 21 days, with a maximal cumulative dose of 550 mg/m2."( Phase II clinical evaluation of 4'-epi-doxorubicin.
Armand, JP; Cappelaere, P; Hurteloup, P; Mathé, G, 1983
)
0.27
" Myelosuppression, nausea and vomiting, and alopecia were the almost frequent side effects, but their incidence seemed lower than that after a comparable dosage of doxorubicin."( A phase-II clinical trial of 4'-epi-doxorubicin in advanced solid tumors.
Bellanova, B; Camaggi, CM; Giovannini, M; Martini, A; Martoni, A; Monetti, N; Pannuti, F; Rossini, G; Tarquinii, M; Tomasi, L, 1984
)
0.27
"9 months) in 52 patients with hepatocellular carcinoma (HCC): An emulsion of Lipiodol and epirubicin was injected as selectively as possible in a dosage proportional to liver function and tumour size."( [The chemoembolization of hepatocellular carcinoma: the computed tomographic findings and clinical results in prospective repetitive therapy].
Brambs, HJ; Claussen, CD; Dette, S; Dietz, K; Duda, SH; Geissler, F; Huppert, PE; Lauchart, W, 1994
)
0.51
" Epirubicin dosage could be increased to 100 mg m-2 in 53 patients (87%), to 110 mg m-2 in 31 patients (51%) and to 120 mg m-2 in 18 cases (30%)."( Laevofolinic acid, 5-fluorouracil, cyclophosphamide and escalating doses of epirubicin with granulocyte colony-stimulating factor support in locally advanced and/or metastatic breast carcinoma: a phase I-II study of the Southern Italy Oncology Group (GOIM
Agostara, B; Cariello, S; Colucci, G; Durini, E; Gebbia, V; Giotta, F; Pacilio, G; Pezzella, G; Romito, S; Testa, A, 1995
)
1.43
"44 patients with advanced breast cancer were treated with high-dose epirubicin (130 mg/sqm), because of its steep dose-response curve."( Phase II study of high-dose epirubicin, lonidamine, alpha 2b interferon in advanced breast cancer.
Bucci, L; Caponigro, F; Di Martino, N; Facchini, G; Fei, L; Iaffaioli, RV; Mantovani, G; Santangelo, M; Tortoriello, A, 1995
)
0.82
"Our aim was to analyse the dose-response rate of 4'-epi-doxorubicin (EP) alone and of EP combined with hyperthermia (HT) treatments in tumor-bearing mice."( 4'-Epi-doxorubicin and hyperthermia in a murine mammary carcinoma: influence of the dose and fractionation.
Altavista, P; Bonanni, M; Cividalli, A; Cruciani, G; Danesi, DT; Persiani, D; Segre, L,
)
0.13
" The lower haematological toxicity of epirubicin, as well as the recent introduction of supportive measures such as colony-stimulating factors, has allowed dose-intensification of epirubicin-containing regimens, which is particularly significant because of the definite dose-response relationship of anthracyclines."( Epirubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cancer chemotherapy.
Faulds, D; Plosker, GL, 1993
)
2
" The dosage of IEP in this study caused moderate toxicity."( Ifosfamide, epirubicin and cisplatin (IEP): another active combination for small cell lung cancer (SCLC).
Jiamsriponges, K; Thongprasert, S, 1993
)
0.66
" A course of radiotherapy consisted of 5 consecutive fractions (3 Gy per fraction, 1 fraction per day) for a total dosage of 15 Gy per course."( Alternated approach with local irradiation and combination chemotherapy including cisplatin or carboplatin plus epirubicin and etoposide in intermediate stage non-small cell lung cancer.
Anania, C; Casaretti, R; Comella, G; Comella, P; Curcio, C; Daponte, A; Maiorino, A; Musetta, G; Scoppa, G, 1994
)
0.5
"5 micrograms/kg protein dosage per day from day-6-day-4 before each course of adjuvant chemotherapy (cyclophosphamide, epirubicin, 5-fluorouracil/cyclophosphamide, methotrexate, 5-fluorouracil alternate) in patients with node-positive breast cancer."( Short-term administration of granulocyte-macrophage colony stimulating factor decreases hematopoietic toxicity of cytostatic drugs.
Aglietta, M; Carnino, F; Gavosto, F; Monzeglio, C; Pasquino, P; Stern, AC, 1993
)
0.49
" All drugs but mafosfamide, tested in place of cyclophosphamide, were used at concentrations corresponding to the in vivo dosage employed in the CEOP regimen."( In vitro chemosensitivity of chronic lymphocytic leukemia B-cells to multidrug regimen (CEOP) compounds using the MTT colorimetric assay.
Brugiatelli, M; Callea, V; Messina, G; Morabito, F; Nobile, F; Oliva, B; Ramirez, F,
)
0.13
"This study validates prospectively the concept of a dose-response relationship for an anthracycline-based chemotherapy in previously untreated advanced breast cancer."( Dose-response relationship of epirubicin-based first-line chemotherapy for advanced breast cancer: a prospective randomized trial.
Andrien, JM; Closon, MT; Dicato, M; Driesschaert, P; Focan, C; Focan-Henrard, D; Lemaire, M; Lobelle, JP; Longree, L; Ries, F, 1993
)
0.57
"Until now, no dose-response correlation has been clearly defined in small cell lung cancer (SCLC)."( Granulocyte-macrophage colony-stimulating factor increases dose intensity of chemotherapy in small cell lung cancer. Relationship between clinical results, peripheral blood cell modifications, and bone marrow kinetics.
Chieco-Bianchi, L; Comis, S; Danova, M; Favaretto, A; Ghiotto, C; Giordano, M; Paccagnella, A; Panozzo, M; Pappagallo, G; Riccardi, A, 1993
)
0.29
" Ifosfamide dosage was not increased."( Epirubicin and ifosfamide in advanced soft tissue sarcoma: a phase II study.
Chevallier, B; Facchini, T; Fargeot, P; Leyvraz, S; Olivier, JP; Vo Van, ML, 1993
)
1.73
"A dose-response relationship for doxorubicin in ovarian cancer (OC) cell lines has been demonstrated in vitro."( High-dose epirubicin in platinum-pretreated patients with ovarian carcinoma: the EORTC-GCCG experience.
Bolis, G; Chevallier, B; Forni, M; Kobierska, A; Pawinski, A; ten Bokkel Huinink, WW; van der Burg, ME; van der Putten, E; Vermorken, JB; Zanaboni, F, 1995
)
0.69
"Individualization of dosing of the FEC regimen using therapeutic drug monitoring and attempts to find concentration-response relationships may be successful, but requires that the exposure of all three drugs is considered simultaneously."( Lack of relationship between systemic exposure for the component drug of the fluorouracil, epirubicin, and 4-hydroxycyclophosphamide regimen in breast cancer patients.
Bergh, J; Fjällskog, ML; Freijs, A; Karlsson, MO; Larsson, R; Nygren, P; Sandström, M, 1996
)
0.51
" A dose-response effect of lenograstim on time to neutrophil recovery was observed both for patients who received chemotherapy on a single day (n = 35) and for those who received chemotherapy over several days (n = 29)."( A single-blind, randomised, vehicle-controlled dose-finding study of recombinant human granulocyte colony-stimulating factor (lenograstim) in patients undergoing chemotherapy for solid cancers and lymphoma.
Berdel, WE; Bron, DG; Cunningham, D; de Campos, E; De Greve, J; Howell, A; Seymour, AM; Steward, WP; Thatcher, N; Tueni, E, 1995
)
0.29
" For both drugs, a loss of linearity of the IC90 and IC50 dose-response curves was found at maximum concentrations."( [Comparison of the cytostatic effect of epirubicin and mitoxantrone on native breast carcinoma cells using the ATP tumor chemosensitivity assay].
Brenne, U; Krebs, D; Kurbacher, CM; Kurbacher, JA; Mallmann, P, 1996
)
0.56
" Nevertheless, recovery was prompt and opportune dosage reductions avoided severe toxicity in subsequent cycles in most patients."( Treatment of advanced urothelial carcinoma with M-VECA (methotrexate, vinblastine, epirubicin and carboplatin).
Comella, P; De Lena, M; Durini, E; Fiorillo, C; Lorusso, V; Pagliarulo, A; Riccardi, F; Selvaggi, FP, 1996
)
0.52
"The addition of IFN-alpha to induction CT appears to confer a survival benefit to SCLC patients but optimal dosing schedule has yet to be defined."( Interferon alpha-2a and combined chemotherapy as first line treatment in SCLC patients: a randomized trial.
Charitopoulos, K; Dimitriadis, K; Economides, D; Maglaveras, N; Papagiannis, A; Vamvalis, C; Zarogoulidis, K; Ziogas, E, 1996
)
0.29
"Echocardiographic reports on 144 adults receiving anthracycline therapy and 18 controls were reviewed for the possible relationship between dosage and ejection fractions."( [Echocardiographic evaluation of cardiotoxicity induced by anthracycline therapy].
Horikawa, K; Okada, Y; Sano, M, 1997
)
0.3
"Ten patients with hormone-refractory prostate cancer received a fixed dosing scheme of suramin infusion in combination with weekly epidoxorubicin at 25 mg/m2."( Suramin/epidoxorubicin association in hormone-refractory prostate cancer: preliminary results of a pilot phase II study.
Boccardo, F; Canobbio, L; Esposito, M; Granetto, C; Miglietta, L; Vannozzi, MO, 1997
)
0.3
" In conclusion, 4'-epidoxorubicin used at this dosage and schedule has minimal activity in metastatic adenocarcinoma of the cervix."( Phase II study of weekly 4'-epidoxorubicin in patients with metastatic adenocarcinoma of the cervix: an EORTC Gynaecological Cancer Cooperative Group study.
Bakker, PJ; Bolis, G; Curran, D; Sahmoud, T; van der Burg, ME; Vermorken, JB, 1997
)
0.3
" Increased dosage of epirubicin and cyclophosphamide could allow a single leukapheresis collection of sufficient HSC from peripheral blood."( [Efficiency of high-dose FEC chemotherapy for the mobilization of hematopoietic stem cells into peripheral blood].
André, M; Canon, JL; Chatelain, B; D'Hondt, L; Doyen, C; Dromelet, A; Feyens, AM; Guillaume, T; Humblet, Y; Longueville, J; Symann, M, 1997
)
0.62
"Chemotherapy with epirubicin was administered to 36 patients with cancer at a dosing rate of 160 mg/m2 as a bolus injection every 21 days to a cumulative dosage of 960 mg/m2."( Clinical relevance of radionuclide angiography and antimyosin immunoscintigraphy for risk assessment in epirubicin cardiotoxicity.
Conti, F; Ferraironi, A; Festa, A; Lopez, M; Maini, CL; Sciuto, R; Tofani, A; Vici, P,
)
0.68
" Similarly, in 11 patients an analysis of actual and predicted neutropenia confirmed that unadjusted dosing would have had no significant effect on the pattern of myelosuppression."( What is the effect of adjusting epirubicin doses for body surface area?
Dobbs, NA; Twelves, CJ, 1998
)
0.58
" It should be considered in individualization of their dosage regimen."( Phenazone as a marker of liver-metabolic function in patients with acute leukemia.
Hurkacz, M; Kotlarek-Haus, S; Orzechowska-Juzwenko, K; Usnarska-Zubkiewicz, L; Wiela-Hojenska, A, 1999
)
0.3
"In vitro data demonstrated a dose-response relationship for doxorubicin in ovarian cancer (OC) cell lines."( Phase I study of high-dose epirubicin in platinum-pretreated patients with ovarian carcinoma.
Forni, M; Kobierska, A; Piccart, MJ; ten Bokkel Huinink, WW; van der Burg, ME; van der Putten, E; Vermorken, JB, 1999
)
0.6
" Doses were determined by a computer-assisted dosing system that used Bayesian pharmacokinetics to maintain suramin plasma concentrations of 200-250 microg/mL."( Suramin in combination with weekly epirubicin for patients with advanced hormone-refractory prostate carcinoma.
Allegrini, G; Antonuzzo, A; Conte, P; Danesi, R; Del Tacca, M; Falcone, A; Masi, G; Monica, L; Pfanner, E; Ricci, S, 1999
)
0.58
" Twenty-one patients were treated in stage I in sequential cohorts of at least three patients at increasing dosage levels of cyclophosphamide and epirubicin, for up to six cycles every 21 days."( Phase I and subsequent phase II study of filgrastim (r-met-HuG-CSF) and dose intensified cyclophosphamide plus epirubicin in patients with non-Hodgkin's lymphoma and advanced solid tumors.
Bishop, J; Fox, RM; Green, MD; Grigg, AP; Levi, J; McKendrick, J; Talbot, SM; Toner, GC; Westerman, DA; Wolf, M; Zalcberg, J, 1999
)
0.72
" A clear dose-response relationship was not observed, since an overall response rate of at least 70% was achieved at all dose levels."( Cisplatin-epirubicin-paclitaxel weekly administration in advanced breast cancer: a phase I study of the Southern Italy Cooperative Oncology Group.
Apicella, A; Bianchi, U; Biglietto, M; Capasso, I; Cartenì, G; Comella, G; Comella, P; D'Aiuto, G; D'Aniello, R; De Lucia, L; Di Bonito, M; Frasci, G; Lapenta, L; Maiorino, L; Piccolo, S; Thomas, R, 1999
)
0.71
" On the other hand, bacillus Calmette-Guerin (BCG) currently appears to be the most effective agent for intravesical use, especially in patients with high grade and stage neoplasms but the optimum strain, dosage and duration schedule have not been determined."( Intravesical therapy of superficial bladder cancer.
Melekos, MD; Moutzouris, GD, 2000
)
0.31
"Anthracyclines are among the most active drugs in the treatment of breast carcinoma and exhibit a steep dose-response curve in vitro."( A phase II trial of high dose epirubicin in patients with advanced breast carcinoma.
Einhorn, LE; Loesch, D; Miller, DK; Munshi, N; Sledge, GW, 2000
)
0.6
"A study of the feasibility of gradually increased epirubicin and cyclophosphamide dosage in an FEC regimen with G-CSF (granulocyte colony stimulating factor) support in 18 high-risk breast cancer patients as adjuvant treatment was carried out."( Acute hematologic feasibility of G-CSF supported dose-escalated FEC therapy as adjuvant treatment after breast cancer surgery.
Hultborn, R; Magnusson, K; Ottosson, S,
)
0.38
"The combination CEF using this schedule and dosage in metastatic breast cancer is more effective with less toxicity than CNF, except for alopecia, and was associated with longer survival."( Phase III trial of cyclophosphamide, epirubicin, fluorouracil (CEF) versus cyclophosphamide, mitoxantrone, fluorouracil (CNF) in women with metastatic breast cancer.
Alvarez, E; Buesa, JM; Corral, N; Estaban, E; Estrada, E; Fernández, JL; Lacave, AJ; Muñiz, I; Palacio, I; Vieitez, JM, 1999
)
0.58
" The latter dosage was therefore considered as the maximal tolerated one."( Phase I-II study of high dose epirubicin plus cisplatin in unresectable non-small-cell lung cancer: searching for the maximal tolerated dose.
Comte-Bardonnet, M; Daurès, JP; Khial, F; Marcillac, I; Oliver, P; Pujol, JL; Quantin, X; Rivière, A, 2000
)
0.6
" Epidoxorubicin (70 mg/m2) was added in patients who previously received a suboptimal dosage of antracycline."( Stop-flow in mediastinum and thorax for resistant lymphoma.
Abate, G; Aigner, KR; Amicucci, G; Benita, C; Capannolo, B; D'Alessandro, V; Filippo, R; Gianfranco, A; Giuseppe, A; Guadagni, S; Luca, M; Marsili, L; Pozone, T; Roland, AK; Russo, F; Stefano, G; Tullio, P; Valfredo, D,
)
0.13
"Six different dosing patterns of each drug were injected within one day."( Haematological toxicity following different dosing schedules of 5-fluorouracil and epirubicin in rats.
Freijs, A; Karlsson, MO; Sandström, M; Simonsen, LE; Wählby, U,
)
0.36
" The aim of the present study was to establish whether decreasing the dosage of epirubicin to 150 mg/m2 would result in the same activity but with less hematological toxicity."( Epirubicin 150 mg/m2-cisplatin versus epirubicin 180 mg/m2-cisplatin for advanced soft tissue sarcoma.
Babović, N; Gavrilović, D; Jelić, S; Kreacić, M; Matković, S; Milanović, N; Tomasević, Z, 1999
)
1.97
"In vitro data demonstrated a dose-response relationship for doxorubicin in ovarian cancer cell lines."( A phase II study of high-dose epirubicin in ovarian cancer patients previously treated with cisplatin. EORTC Gynecological Cancer Cooperative Group.
Bolis, G; Chevallier, B; Kobierska, A; Pawinski, A; Vermorken, JB; Zanaboni, F, 2000
)
0.6
" In conclusion, liposomal preparations of CsA may circumvent MDR and have the advantage of diminishing side effects, thus providing a useful alternative dosage form for intravenous administration of CsA to be combined with cytotoxic agents for the treatment of resistant tumors."( Reversal of multidrug resistance to epirubicin by cyclosporin A in liposomes or intralipid.
Cherng, JY; Liu, FI; Lo, YL; Yang, JM,
)
0.41
"This three-arm study does not show an advantage in favor of an adequately dosed epirubicin-based regimen over classical CMF in the adjuvant therapy of node-positive pre- and postmenopausal women with breast cancer."( Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide with cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer.
Bartholomeus, S; Beauduin, M; Beauvois, S; Closon-Dejardin, MT; Di Leo, A; Dolci, S; Dufrane, JP; Finet, C; Focan, C; Gobert, P; Kerger, J; Liebens, F; Lobelle, JP; Michel, J; Nogaret, JM; Paesmans, M; Piccart, MJ; Ries, F; Tagnon, A; Vindevoghel, A, 2001
)
0.8
" Five patients who treated with steroids at the onset of neurological symptoms showed clinical improvement, regardless of their age, sex, the pathology and stage of breast cancer, or the total dosage of chemotherapeutic agents."( 5-fluorouracil-induced leukoencephalopathy in patients with breast cancer.
Cho, KH; Choi, SM; Kim, BC; Kim, MK; Lee, SH; Yang, YS, 2001
)
0.31
" hM-CSF dosing significantly increased monocyte, lymphocyte, granulocyte, and platelet counts that were decreased by CTX."( Effect of human urinary macrophage colony-stimulating factor on the immune functions and the blood cell counts in patients with ovarian carcinoma receiving cytotoxic chemotherapy.
Hasumi, K; Shimizu, K; Shimizu, Y; Suzuki, M; Takaku, F; Umezawa, S; Utsugi, K,
)
0.13
" We sought to determine the distribution of body size and prevalence of obesity in the breast cancer population of our cancer centre, and to determine clinician chemotherapy dosing practices in the era of modern adjuvant chemotherapy."( Are medical oncologists biased in their treatment of the large woman with breast cancer?
Bjarnason, GA; Franssen, E; Madarnas, Y; Sawka, CA, 2001
)
0.31
" We reviewed the first cycle adjuvant chemotherapy dosing practices from 1990-1998."( Are medical oncologists biased in their treatment of the large woman with breast cancer?
Bjarnason, GA; Franssen, E; Madarnas, Y; Sawka, CA, 2001
)
0.31
" Liposomal preparations of PSC833 may provide a useful alternative dosage form for intravenous administration of PSC 833 to be combined with anticancer drugs to circumvent drug resistance in cancer chemotherapy."( Effect of PSC 833 liposomes and Intralipid on the transport of epirubicin in Caco-2 cells and rat intestines.
Cherng, J; Liu, F; Lo, Y, 2001
)
0.55
" Cumulative dose-response plots of primary breast cancer tumor cells responding in vitro with > or = 90% growth inhibition showed a strong dose dependence for both EPI/PTX and CBDCA/PTX."( Drug interactions and cytotoxic effects of paclitaxel in combination with carboplatin, epirubicin, gemcitabine or vinorelbine in breast cancer cell lines and tumor samples.
Beryt, M; Felber, M; Hepp, H; Kahlert, S; Konecny, G; Langer, E; Lude, S; Pegram, M; Slamon, D; Untch, M, 2001
)
0.53
" Clinical trials with epirubicin have examined the importance of a dose-response relationship, therapeutic dose, and optimum duration of chemotherapy."( Epirubicin in breast cancer: present and future.
Levine, M, 2000
)
2.06
"To investigate the effects of the dosage of anticancer agents during transcatheter arterial chemoembolization (TACE) on the T cell subsets in patients with hepatocellular carcinoma (HCC)."( Effect of dosage of anticancer agents during transcatheter arterial chemoembolization on T cell subsets in patients with hepatocellular carcinoma.
Chen, Y; He, XF; Li, YH; Lu, W; Qiu, YR; Zeng, QL, 2002
)
0.31
" Compared with the cell necrosis, the dosage of drugs was less and the time was shorter for inducing apoptosis."( [Apoptosis of human pancreatic carcinoma cell lines induced by combinations of chemotherapeutic drugs].
Cai, L; Liao, Q; Wu, Y; Zhao, Y; Zhu, Y, 1999
)
0.3
" Adaptive dosing was evaluated prospectively in a third group of 41 women with serum AST > or =2xnormal+/-raised bilirubin."( Epirubicin in patients with liver dysfunction: development and evaluation of a novel dose modification scheme.
Cruickshanka, C; Dobbs, NA; Gregory, W; Richards, MA; Rubens, RD; Twelves, CJ, 2003
)
1.76
"To use a population approach to identify readily available clinical or biochemical characteristics that influence the pharmacokinetics of epirubicin and to develop new dosage guidelines based on these results."( A population model of epirubicin pharmacokinetics and application to dosage guidelines.
Dobbs, NA; Ralph, LD; Thomson, AH; Twelves, C, 2003
)
0.84
"The proposed dosing guidelines should reduce variability in systemic exposure to epirubicin more effectively than traditional approaches."( A population model of epirubicin pharmacokinetics and application to dosage guidelines.
Dobbs, NA; Ralph, LD; Thomson, AH; Twelves, C, 2003
)
0.86
" EDX dosage was chosen after a pilot phase I study."( First-line chemotherapy with epidoxorubicin, paclitaxel, and carboplatin for the treatment of advanced epithelial ovarian cancer patients.
Carnino, F; Conte, PF; Cosio, S; Fanucchi, A; Gadducci, A; Lionetto, R; Pastorino, S; Romanini, A; Tanganelli, L, 2003
)
0.32
"To assess efficacy and optimum combination dosage of intravenous docetaxel (T), epirubicin (E) and vinorelbine (N) administered every 2 weeks and without colony stimulating factor (CSF) support in patients with metastatic breast cancer (MBC)."( Combination of docetaxel, epirubicin and vinorelbine administered every 2 weeks as first-line therapy in patients with metastatic breast cancer: a dose-finding study.
Corral, N; Esteban, E; Estrada, E; Fernández, Y; Fra, J; González de Sande, L; Lacave, AJ; Modollel, A; Muñiz, I; Palacio, I; Sala, M; Vieitez, JM, 2003
)
0.85
" Most cytostatics demonstrate a marked inter-individual variation in different pharmacokinectic parameters, not compensated for by dosage based on body surface area."( Best use of adjuvant systemic therapies II, chemotherapy aspects: dose of chemotherapy-cytotoxicity, duration and responsiveness.
Bergh, J, 2003
)
0.32
" Additional phase II trials have focused on optimizing dosing and schedule schemas with the demonstration of impressive efficacy with acceptable toxicity with the biweekly administration."( Gemcitabine and docetaxel in metastatic and neoadjuvant treatment of breast cancer.
Yardley, DA, 2004
)
0.32
" Proper dosing and monitoring may further enhance tolerability while preserving the efficacy of this versatile agent for ovarian cancer."( Liposomal anthracycline treatment for ovarian cancer.
Gordon, AN; Markman, M; McGuire, WP; Muggia, FM, 2004
)
0.32
"Many investigations have focused on an optimal dosing schedule for paclitaxel since its regulatory approval."( A simplified premedication schedule for 1-hour paclitaxel administration.
Kosmas, C; Tsavaris, N; Vadiaka, M,
)
0.13
" Thus, the visual and chemical compatibility of irinotecan and epirubicin in the same infusion solution were investigated using both reference standards and pharmaceutical dosage forms."( Spectrophotometric investigation of the chemical compatibility of the anticancer drugs irinotecan-HCl and epirubicin-HCl in the same infusion solution.
Anilanmert, B; Ozdemir, FA; Pekin, M, 2005
)
0.78
" We dosed 6 cycles of FEC chemotherapy (CPA 800 mg, EPI 80 mg, 5-FU 750 mg/body x 1 cycle)."( [A case of breast cancer detected by MRI mammography after Hollywood syndrome].
Amano, S; Enomoto, K; Kitajima, A; Matsuo, S; Negishi, N; Nemoto, N; Oinuma, T; Sakurai, K, 2005
)
0.33
" We extracted relevant factors such as age, previous illness, physical condition and dosage of epirubicin hydrochloride from past records which may all be connected to the outbreak of vasculitis."( [Vasculitic condition following instillation of epirubicin hydrochloride in an outpatient chemotherapy].
Asako, E; Honda, A; Matsubara, Y; Nakazawa, Y; Suzuki, M, 2005
)
0.8
" Our finding does not exclude the possibility that long-term GC treatment has adverse effects, and it should also be emphasized that treatment duration, dosage and dosing regimens, as well as the choice of an appropriate GC and the mode of application, determine the risks and benefits."( Glucocorticosteroid receptors in ovarian carcinomas.
Franke, FE; Hackethal, A; Münstedt, K; Von Georgi, R; Woenckhaus, J, 2006
)
0.33
" 5-fluoruracil 750 mg sq m(-1), leucovorin 75 mg sq m(-1), epirubicin 45 mg sq m(-1), carboplatin 225 mg sq m(-1) were administered every 3 weeks into celiac axis for three cycles (FLEC regimen), then gemcitabine at the dosage of 1 g sq m(-1) on days 1, 8 and 15 every 4 weeks for 3 months (FLECG regimen)."( Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancreatic adenocarcinoma.
Cantore, M; Capelli, P; Fiorentini, G; Iacono, C; Lombardi, M; Mambrini, A; Pacetti, P; Pagani, M; Pederzoli, P; Pulica, C; Serio, G; Torri, T, 2006
)
0.83
" Low dosage endocrine agent-induced anthracycline sensitization may be independent of mitochondrial toxicity."( Medroxyprogesterone and tamoxifen augment anti-proliferative efficacy and reduce mitochondria-toxicity of epirubicin in FM3A tumor cells in vitro.
Altinoz, MA; Bilir, A; Gedikoglu, G; Muslumanoglu, M; Oktem, G; Ozcan, E, 2007
)
0.55
"Chemotherapy dosing only based on body surface area (BSA) results in marked pharmacokinetic and toxicity variations, which may result in an inferior outcome for some patients."( Individually tailored toxicity-based 5-fluorouracil, epirubicin and cyclophosphamide (FEC) therapy of metastatic breast cancer.
Ahlgren, J; Aström, G; Bergh, J; Blomqvist, C; Lindman, H; Nygren, P; Villman, K, 2007
)
0.59
" Compared with EPI monotherapy, the combination of EPI and EPA can reduce the dosage of EPI."( [Effect of combination of eicosapentaenoic acid and epirubicin on human gastric carcinoma cell strain MGC-803].
Dong, JH; Gu, B; Guo, WD; Kang, WM; Liu, YQ; Peng, WZ; Yu, JC, 2007
)
0.59
"In our study intensive cyclic EC chemotherapy did not show better curative effect when compared with conventional dosage chemotherapy."( Intensive cyclic chemotherapy and transplantation of autologous peripheral blood progenitor cells (PBPC) or whole blood in high-risk breast cancer - follow up at 10 years.
Blaha, M; Cinek, P; Filip, S; Mericka, P; Vanasek, J; Zouhar, M, 2007
)
0.34
" Dosing of S-1 is different between Western and Asian populations due to differences in metabolism by CYP2A6."( Medical treatment for advanced gastroesophageal adenocarcinoma.
Ajani, JA; Cen, P, 2007
)
0.34
"Cisplatin (DDP) in large dosage impairs renal functions, while the impact of fractionated low dose DDP on renal functions is unclear."( [Effects of fractionated low dose Cisplatin on renal functions of patients with gastric carcinoma].
Jin, ML; Li, J; Li, Y; Shen, L, 2007
)
0.34
" The cumulative dosage of epirubicin that carries a 5% risk of cardiotoxicity was lower than previously assumed and was dependent on risks of both cardiotoxicity and overall mortality."( New insight into epirubicin cardiac toxicity: competing risks analysis of 1097 breast cancer patients.
Andersen, PK; Cortese, G; Nielsen, D; Nielsen, G; Ryberg, M; Skovsgaard, T, 2008
)
0.99
"To examine the effects of verapamil on the intracellular drug pharmacokinetics of epirubicin using alternative dosing schedules."( Time-lapse live cell imaging and flow analysis of multidrug resistance reversal by verapamil in bladder cancer cell lines.
Birch, BR; Cooper, AJ; Featherstone, JM; Hayes, MC; Lwaleed, BA; Speers, AG, 2009
)
0.58
" Flow cytometry was performed after the alternative dosing regimens."( Time-lapse live cell imaging and flow analysis of multidrug resistance reversal by verapamil in bladder cancer cell lines.
Birch, BR; Cooper, AJ; Featherstone, JM; Hayes, MC; Lwaleed, BA; Speers, AG, 2009
)
0.35
" The present results highlight the need for additional clinical trials of drug dosing and scheduling for combination intravesical chemotherapy regimens."( Time-lapse live cell imaging and flow analysis of multidrug resistance reversal by verapamil in bladder cancer cell lines.
Birch, BR; Cooper, AJ; Featherstone, JM; Hayes, MC; Lwaleed, BA; Speers, AG, 2009
)
0.35
" However, optimal schedule and dosing of chemotherapy still need to be developed to reduce distant metastasis."( Concurrent chemoradiation followed by adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma in Korea.
Choi, IK; Jung, KY; Kim, CY; Kim, JS; Kim, YH; Lee, NJ; Oh, SC; Park, KH; Park, Y; Park, YJ; Seo, HY; Seo, JH; Shin, SW, 2010
)
0.36
" For Docetaxel and 5-FU, a linear correlation between this sensitizing effect and the ascorbate dosage is observed."( Ascorbate exerts anti-proliferative effects through cell cycle inhibition and sensitizes tumor cells towards cytostatic drugs.
Aigner, A; Czubayko, F; Frömberg, A; Gutsch, D; Schulze, D; Vollbracht, C; Weiss, G, 2011
)
0.37
" Different liposome preparations were administered in rats by intravenous injection at the same dosage of 12 mg·kg(-1)."( Epirubicin-encapsulated long-circulating thermosensitive liposome improves pharmacokinetics and antitumor therapeutic efficacy in animals.
Lü, WL; Mei, XG; Wu, C; Wu, Y; Yang, Y; Zhang, FC, 2011
)
1.81
"59 primary M0 breast cancer patients received pre-operative sequential dose-dense epirubicin and cyclophosphamide followed by docetaxel (19 patients at dosage 100 mg/m(2), 40 patients at 75 mg/m(2))."( Impact of tumor biology, particularly triple-negative status, on response to pre-operative sequential, dose-dense epirubicin, cyclophosphamide followed by docetaxel in breast cancer.
Grosse-Onnebrink, E; Harbeck, N; Hoopmann, M; Kates, R; Mallmann, P; Stoff-Khalili, M; Thomas, A; Warm, M, 2010
)
0.8
" Hand-foot syndrome occurred in 12/19 patients treated at the higher docetaxel dosage but only 1/40 of the remaining patients."( Impact of tumor biology, particularly triple-negative status, on response to pre-operative sequential, dose-dense epirubicin, cyclophosphamide followed by docetaxel in breast cancer.
Grosse-Onnebrink, E; Harbeck, N; Hoopmann, M; Kates, R; Mallmann, P; Stoff-Khalili, M; Thomas, A; Warm, M, 2010
)
0.57
" Regimen-related toxicity resulted in at least one treatment delay or dosage reduction in 63."( Evaluation of two modified ECF regimens in the treatment of advanced gallbladder cancer.
Li, SG; Liu, YB; Quan, ZW; Shen, J; Shi, WB; Wang, JD; Wang, XF; Yang, Y; Zhou, XP; Zhuang, PY, 2011
)
0.37
"After a first standard dosed FEC course (5-fluorouracil 600 mg/m(2), epirubicin 60 mg/mg(2) and cyclophosphamide 600 mg/m(2)), patients who did not reach leukopenia grade III or IV were randomised to standard doses (group standard) or doses tailored to achieve grade III leukopenia (group tailored) at courses 2-7."( Dose-tailoring of FEC adjuvant chemotherapy based on leukopenia is feasible and well tolerated. Toxicity and dose intensity in the Scandinavian Breast Group phase 3 adjuvant Trial SBG 2000-1.
Ahlgren, J; Andersson, M; Bengtsson, NO; Bergh, J; Bjerre, K; Blomqvist, C; Edlund, P; Holmberg, SB; Jakobsen, E; Lindman, H; Mouridsen, H; Møller, S, 2011
)
0.6
" Ninety percent of the patients in the tailored arm achieved leukopenia grade III-IV compared with 29% among patients randomised to standard dosed therapy."( Dose-tailoring of FEC adjuvant chemotherapy based on leukopenia is feasible and well tolerated. Toxicity and dose intensity in the Scandinavian Breast Group phase 3 adjuvant Trial SBG 2000-1.
Ahlgren, J; Andersson, M; Bengtsson, NO; Bergh, J; Bjerre, K; Blomqvist, C; Edlund, P; Holmberg, SB; Jakobsen, E; Lindman, H; Mouridsen, H; Møller, S, 2011
)
0.37
"Patients who received higher doses, based on the tailored dosing strategy, did not seem to have worse HRQoL than those who had lower doses."( Tailored chemotherapy doses based on toxicity in breast cancer result in similar quality of life values, irrespective of given dose levels.
Bergh, J; Brandberg, Y; Iiristo, M; Wiklund, T; Wilking, N, 2011
)
0.37
"v with the same dosage (12 mg kg(-1))."( [Pharmacokinetics of epirubicin hydrochloride long-circulating thermosensitive liposomes in rat plasma].
Lü, WL; Mei, XG; Wu, C; Wu, Y; Zhang, FC, 2010
)
0.68
" TEC chemotherapy (paclitaxel, epirubicin, and carboplatin) has been suggested to have less toxicity; however, the optimal dosage has yet to be determined."( Chemotherapy for endometrial carcinoma (GOGO-EM1 study): TEC (paclitaxel, epirubicin, and carboplatin) is an effective remission-induction and adjuvant therapy.
Asada, M; Egawa-Takata, T; Enomoto, T; Fujita, M; Ito, K; Kimura, T; Kuragaki, C; Miyake, T; Miyatake, T; Morishige, K; Nagamatsu, M; Nakashima, R; Nishio, Y; Nishizaki, T; Ogita, K; Okazawa, M; Tsutsui, T; Ueda, Y; Wakimoto, A; Yamamoto, T; Yamasaki, M; Yoshino, K, 2011
)
0.89
" Feasibility still depends largely on several factors including the choice of drugs, dosage and sequence of administration."( High rate of extra-haematological toxicity compromises dose-dense sequential adjuvant chemotherapy for breast cancer.
Asselain, B; Bonnetain, F; Brain, E; Delva, R; Fumoleau, P; Gauthier, M; Jimenez, M; Levy, C; Martin, AL; Mauriac, L; Rios, M; Roché, H; Serin, D; Spielmann, M; Veyret, C, 2011
)
0.37
" We are the first to demonstrate the nanomedical strategy that can overcome the CMDR and NDR bladder cancers simultaneously, and proceed to the excellent MT therapy, significantly reducing the dosage and cardiotoxicity and holding great promise for incurable human MDR bladder cancer."( An epirubicin-conjugated nanocarrier with MRI function to overcome lethal multidrug-resistant bladder cancer.
Chuang, CK; Hsu, PH; Hua, MY; Liu, HL; Pang, ST; Tang, HJ; Tsai, RY; Yang, HW; Yen, TC, 2012
)
1
" However, it is difficult to achieve a sufficient antitumor effect because of dosage limitation to prevent cardiotoxicity."( NC-6300, an epirubicin-incorporating micelle, extends the antitumor effect and reduces the cardiotoxicity of epirubicin.
Harada, M; Hayashi, T; Hyodo, I; Kato, Y; Kinoshita, T; Koga, Y; Kuroda, J; Matsumura, Y; Ohkohchi, N; Saito, H; Takahashi, A; Takigahira, M; Yamamoto, Y; Yasunaga, M, 2013
)
0.77
" Larger studies with more frequent dosing of zoledronic acid are needed to assess these complex interactions more thoroughly."( Neoadjuvant chemotherapy with or without zoledronic acid in early breast cancer--a randomized biomarker pilot study.
Coleman, RE; Cross, SS; Evans, A; Freeman, JV; Hatton, MQ; Holen, I; Ingram, CE; Jolley, IJ; Mori, S; Syddall, SP; Wilson, C; Winter, MC, 2013
)
0.39
" The major formulations were prepared as the liquid and solid suppository dosage forms."( Evaluation of epirubicin in thermogelling and bioadhesive liquid and solid suppository formulations for rectal administration.
Lin, HR; Lin, Y; Lo, YL, 2013
)
0.75
" Full body surface areas-based dosing appears to be tolerated as well in obese as in lean women."( Toxicity and tolerability of adjuvant breast cancer chemotherapy in obese women.
Carroll, JP; Cheng, ME; Fay, M; Martin, JH; Nguyen, L; Pillay, PS; Protani, MM; Saleem, M; Walpole, E, 2014
)
0.4
"Epirubicin (EPI) elicits poor-oral bioavailability hence commercially available as injection for intravenous administration which follows a rapid increase and fast decay in plasma drug concentration often needs a frequent dosing that may lead to serious side effects."( Improved oral efficacy of epirubicin through polymeric nanoparticles: pharmacodynamic and toxicological investigations.
Alam, MA; Panda, AK; Singh, AT; Talegaonkar, S; Tariq, M, 2016
)
2.18
" We have developed a mathematical model to optimize drug dosing regimens and to redesign the dose intensification-dose escalation process, using densified cycles of combined anticancer drugs."( Revisiting Dosing Regimen Using Pharmacokinetic/Pharmacodynamic Mathematical Modeling: Densification and Intensification of Combination Cancer Therapy.
Barbolosi, D; Ciccolini, J; Freyer, G; Iliadis, A; Meille, C, 2016
)
0.43
" Dose densification was guided by a model of neutrophil kinetics, able to optimize docetaxel plus epirubicin dosing with respect to pre-defined acceptable levels of hematological toxicity while ensuring maximal efficacy."( Revisiting dosing regimen using PK/PD modeling: the MODEL1 phase I/II trial of docetaxel plus epirubicin in metastatic breast cancer patients.
Barbolosi, D; Freyer, G; Guitton, J; Hénin, E; Iliadis, A; Meille, C; You, B, 2016
)
0.87
" The ifosfamide dosage was reduced to two-thirds of the original protocol."( Dose-Modified Ifosfamide, Epirubicin, and Etoposide is a Safe and Effective Salvage Therapy with High Peripheral Blood Stem Cell Mobilization Capacity for Poorly Mobilized Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma Patients.
Arima, N; Fukunaga, A; Hyuga, M; Iwasaki, M; Kishimoto, W; Maesako, Y; Nakae, Y, 2016
)
0.73
"Standard dosing of chemotherapy based on body surface area results in marked interpatient variation in pharmacokinetics, toxic effects, and efficacy."( Effect of Tailored Dose-Dense Chemotherapy vs Standard 3-Weekly Adjuvant Chemotherapy on Recurrence-Free Survival Among Women With High-Risk Early Breast Cancer: A Randomized Clinical Trial.
Anderson, H; Bengtsson, NO; Bergh, J; Brandberg, Y; Carlsson, L; Egle, D; Fornander, T; Foukakis, T; Gnant, M; Greil, R; Hellström, M; Johansson, H; Karlsson, E; Loibl, S; Malmström, P; Mlineritsch, B; Möbus, V; Schmatloch, S; Singer, CF; Steger, G; Untch, M; von Minckwitz, G; Wallberg, B, 2016
)
0.43
"The previously reported OS benefit of iddEPC in comparison to conventionally dosed EC → P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up."( Ten-year results of intense dose-dense chemotherapy show superior survival compared with a conventional schedule in high-risk primary breast cancer: final results of AGO phase III iddEPC trial.
du Bois, A; Harbeck, N; Hinke, A; Huober, J; Jackisch, C; Konecny, GE; Kuhn, W; Kurbacher, C; Lück, HJ; Möbus, V; Nitz, U; Runnebaum, IB; Schneeweiss, A; Thomssen, C; Untch, M; von Minckwitz, G, 2018
)
0.48
"Although several studies have shown efficacy of nanoparticle albumin-bound (nab) paclitaxel use as a neoadjuvant treatment in breast cancer, dosage and schedules were varied or used in combination and the data are still limited for weekly regimens."( Feasibility Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (150 mg/m
Akiyama, K; Haku, E; Hayami, R; Kawamoto, H; Kojima, Y; Nishikawa, T; Shimo, A; Tsugawa, K, 2018
)
0.48
"Although ECT was the most accurate imaging method, its high cost and large radiation dosage limit its widespread application."( Diagnostic accuracy of MR, CT, and ECT in the differentiation of neoplastic from nonneoplastic spine lesions.
Bian, C; Dong, J; Hu, A; Jiang, L; Liang, Y; Liu, P; Wang, H; Zhou, X, 2020
)
0.56
" Chemotherapy has a narrow therapeutic window and requires high dosage treatment in patients with advanced-stage cancers and further need innovative treatment strategies."( Breast cancer: insights in disease and influence of drug methotrexate.
Amorim, I; Gärtner, F; Gouveia, MJ; Koksch, B; Santos, J; Vale, N; Yang, V, 2020
)
0.56
" Patients were dosed using the recommended dose of 150 mg/m2 intravenously (IV) once every 3 weeks."( Results of NC-6300 (Nanoparticle Epirubicin) in an Expansion Cohort of Patients with Angiosarcoma.
Ahari, A; Chawla, SP; Chua, V; Krkyan, N; Moradkhani, A; Osada, A; Riedel, RF, 2022
)
1
" It is unclear whether under- or overexposure occurs in pregnant cancer patients and thus also whether adjustments in dosing regimens are required."( Semi-physiological Enriched Population Pharmacokinetic Modelling to Predict the Effects of Pregnancy on the Pharmacokinetics of Cytotoxic Drugs.
Amant, FCH; Beijnen, JH; Damoiseaux, D; Dorlo, TPC; Huitema, ADR; Janssen, JM; van Calsteren, K; van Hasselt, JGC, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitorA topoisomerase inhibitor that inhibits DNA topoisomerase (ATP-hydrolysing), EC 5.99.1.3 (also known as topoisomerase II and as DNA gyrase), which catalyses ATP-dependent breakage of both strands of DNA, passage of the unbroken strands through the breaks, and rejoining of the broken strands.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
antimicrobial agentA substance that kills or slows the growth of microorganisms, including bacteria, viruses, fungi and protozoans.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (8)

ClassDescription
anthracyclineAnthracyclines are polyketides that have a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine.
deoxy hexoside
anthracycline antibioticAn organic compound that has a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine and which exhibits antibiotic activity.
aminoglycoside
monosaccharide derivativeA carbohydrate derivative that is formally obtained from a monosaccharide.
p-quinonesA quinone in which the two oxo groups of the quinone are located para to each other on the 6-membered quinonoid ring.
primary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a -CH2 (methylene) group.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (9)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Fumarate hydrataseHomo sapiens (human)Potency0.29570.00308.794948.0869AID1347053
PPM1D proteinHomo sapiens (human)Potency0.82890.00529.466132.9993AID1347411
EWS/FLI fusion proteinHomo sapiens (human)Potency0.12100.001310.157742.8575AID1259252; AID1259253; AID1259255; AID1259256
polyproteinZika virusPotency0.29570.00308.794948.0869AID1347053
Interferon betaHomo sapiens (human)Potency0.82890.00339.158239.8107AID1347411
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency5.85480.009610.525035.4813AID1479145; AID1479148
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Genome polyprotein IC50 (µMol)0.75000.70001.95673.8000AID240983
Tyrosine-protein kinase FynHomo sapiens (human)IC50 (µMol)5.18100.00021.67898.6800AID625185
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (89)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
response to singlet oxygenTyrosine-protein kinase FynHomo sapiens (human)
neuron migrationTyrosine-protein kinase FynHomo sapiens (human)
stimulatory C-type lectin receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
adaptive immune responseTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of inflammatory response to antigenic stimulusTyrosine-protein kinase FynHomo sapiens (human)
heart processTyrosine-protein kinase FynHomo sapiens (human)
protein phosphorylationTyrosine-protein kinase FynHomo sapiens (human)
calcium ion transportTyrosine-protein kinase FynHomo sapiens (human)
G protein-coupled glutamate receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
axon guidanceTyrosine-protein kinase FynHomo sapiens (human)
learningTyrosine-protein kinase FynHomo sapiens (human)
feeding behaviorTyrosine-protein kinase FynHomo sapiens (human)
regulation of cell shapeTyrosine-protein kinase FynHomo sapiens (human)
gene expressionTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of gene expressionTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of hydrogen peroxide biosynthetic processTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of neuron projection developmentTyrosine-protein kinase FynHomo sapiens (human)
protein ubiquitinationTyrosine-protein kinase FynHomo sapiens (human)
peptidyl-tyrosine phosphorylationTyrosine-protein kinase FynHomo sapiens (human)
protein catabolic processTyrosine-protein kinase FynHomo sapiens (human)
forebrain developmentTyrosine-protein kinase FynHomo sapiens (human)
T cell costimulationTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of protein ubiquitinationTyrosine-protein kinase FynHomo sapiens (human)
intracellular signal transductionTyrosine-protein kinase FynHomo sapiens (human)
cellular response to platelet-derived growth factor stimulusTyrosine-protein kinase FynHomo sapiens (human)
Fc-gamma receptor signaling pathway involved in phagocytosisTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of protein catabolic processTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of tyrosine phosphorylation of STAT proteinTyrosine-protein kinase FynHomo sapiens (human)
response to ethanolTyrosine-protein kinase FynHomo sapiens (human)
vascular endothelial growth factor receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
ephrin receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
dendrite morphogenesisTyrosine-protein kinase FynHomo sapiens (human)
regulation of peptidyl-tyrosine phosphorylationTyrosine-protein kinase FynHomo sapiens (human)
activated T cell proliferationTyrosine-protein kinase FynHomo sapiens (human)
modulation of chemical synaptic transmissionTyrosine-protein kinase FynHomo sapiens (human)
T cell receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
leukocyte migrationTyrosine-protein kinase FynHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of painTyrosine-protein kinase FynHomo sapiens (human)
cellular response to hydrogen peroxideTyrosine-protein kinase FynHomo sapiens (human)
cellular response to transforming growth factor beta stimulusTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of protein targeting to membraneTyrosine-protein kinase FynHomo sapiens (human)
dendritic spine maintenanceTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of protein localization to nucleusTyrosine-protein kinase FynHomo sapiens (human)
regulation of glutamate receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of oxidative stress-induced intrinsic apoptotic signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of dendritic spine maintenanceTyrosine-protein kinase FynHomo sapiens (human)
response to amyloid-betaTyrosine-protein kinase FynHomo sapiens (human)
cellular response to amyloid-betaTyrosine-protein kinase FynHomo sapiens (human)
cellular response to L-glutamateTyrosine-protein kinase FynHomo sapiens (human)
cellular response to glycineTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of protein localization to membraneTyrosine-protein kinase FynHomo sapiens (human)
regulation of calcium ion import across plasma membraneTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of cysteine-type endopeptidase activityTyrosine-protein kinase FynHomo sapiens (human)
innate immune responseTyrosine-protein kinase FynHomo sapiens (human)
cell differentiationTyrosine-protein kinase FynHomo sapiens (human)
cell surface receptor protein tyrosine kinase signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
lipid metabolic processUDP-glucuronosyltransferase 2B7Homo sapiens (human)
xenobiotic metabolic processUDP-glucuronosyltransferase 2B7Homo sapiens (human)
androgen metabolic processUDP-glucuronosyltransferase 2B7Homo sapiens (human)
estrogen metabolic processUDP-glucuronosyltransferase 2B7Homo sapiens (human)
cellular glucuronidationUDP-glucuronosyltransferase 2B7Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (25)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
protein tyrosine kinase activityTyrosine-protein kinase FynHomo sapiens (human)
non-membrane spanning protein tyrosine kinase activityTyrosine-protein kinase FynHomo sapiens (human)
protein bindingTyrosine-protein kinase FynHomo sapiens (human)
ATP bindingTyrosine-protein kinase FynHomo sapiens (human)
phospholipase activator activityTyrosine-protein kinase FynHomo sapiens (human)
enzyme bindingTyrosine-protein kinase FynHomo sapiens (human)
type 5 metabotropic glutamate receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
identical protein bindingTyrosine-protein kinase FynHomo sapiens (human)
alpha-tubulin bindingTyrosine-protein kinase FynHomo sapiens (human)
phospholipase bindingTyrosine-protein kinase FynHomo sapiens (human)
transmembrane transporter bindingTyrosine-protein kinase FynHomo sapiens (human)
metal ion bindingTyrosine-protein kinase FynHomo sapiens (human)
ephrin receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
tau protein bindingTyrosine-protein kinase FynHomo sapiens (human)
tau-protein kinase activityTyrosine-protein kinase FynHomo sapiens (human)
growth factor receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
scaffold protein bindingTyrosine-protein kinase FynHomo sapiens (human)
disordered domain specific bindingTyrosine-protein kinase FynHomo sapiens (human)
signaling receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
retinoic acid bindingUDP-glucuronosyltransferase 2B7Homo sapiens (human)
glucuronosyltransferase activityUDP-glucuronosyltransferase 2B7Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (20)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
membrane raftTyrosine-protein kinase FynHomo sapiens (human)
dendriteTyrosine-protein kinase FynHomo sapiens (human)
nucleusTyrosine-protein kinase FynHomo sapiens (human)
mitochondrionTyrosine-protein kinase FynHomo sapiens (human)
endosomeTyrosine-protein kinase FynHomo sapiens (human)
cytosolTyrosine-protein kinase FynHomo sapiens (human)
actin filamentTyrosine-protein kinase FynHomo sapiens (human)
plasma membraneTyrosine-protein kinase FynHomo sapiens (human)
postsynaptic densityTyrosine-protein kinase FynHomo sapiens (human)
dendriteTyrosine-protein kinase FynHomo sapiens (human)
perikaryonTyrosine-protein kinase FynHomo sapiens (human)
cell bodyTyrosine-protein kinase FynHomo sapiens (human)
membrane raftTyrosine-protein kinase FynHomo sapiens (human)
perinuclear region of cytoplasmTyrosine-protein kinase FynHomo sapiens (human)
perinuclear endoplasmic reticulumTyrosine-protein kinase FynHomo sapiens (human)
glial cell projectionTyrosine-protein kinase FynHomo sapiens (human)
Schaffer collateral - CA1 synapseTyrosine-protein kinase FynHomo sapiens (human)
plasma membraneTyrosine-protein kinase FynHomo sapiens (human)
endoplasmic reticulum membraneUDP-glucuronosyltransferase 2B7Homo sapiens (human)
membraneUDP-glucuronosyltransferase 2B7Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (251)

Assay IDTitleYearJournalArticle
AID1888646Cytotoxicity against human A549 cells assessed as inhibition of cell proliferation measured after 68 hrs by MTT assay2022Journal of natural products, 03-25, Volume: 85, Issue:3
Discovery, Structure Correction, and Biosynthesis of Actinopyrones, Cytotoxic Polyketides from the Deep-Sea Hydrothermal-Vent-Derived
AID1611335Binding affinity to human telomeric 7 G-quadruplex DNA assessed as fluorescence quenching at 7 uM in presence of 100 to 150 mM K+ ion by fluorescence spectral analysis relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1611359Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 in 50 mM of KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611358Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 in absence of KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611330Binding affinity to human telomeric 7 G-quadruplex DNA assessed as delta Tm1 compound:DNA ratio of 2:0 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611306Binding affinity to human telomeric 7 G-quadruplex DNA assessed as drug-DNA complex stoichiometry ratio of 1:1 at 7 uM by absorption spectroscopy2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID683329Cytotoxicity against human Bel7402 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID240983Inhibitory concentration against hepatitis C virus helicase2005Journal of medicinal chemistry, Jan-13, Volume: 48, Issue:1
Control of hepatitis C: a medicinal chemistry perspective.
AID683803Cytotoxicity against human Caco2 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1354668Cytotoxicity against human MCF10A cells after 48 hrs by MTT assay2018Journal of natural products, 05-25, Volume: 81, Issue:5
Cytotoxic Anthracycline Metabolites from a Recombinant Streptomyces.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1565530Cell cycle arrest in rat C6 cells assessed as decrease in cell population at G2/M phase measured after 24 hrs by propidium iodide staining based flow cytometry analysis2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Structural tuning of acridones for developing anticancer agents targeting dihydrofolate reductase.
AID683331Cytotoxicity against human HL-7702 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1611315Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 at 591 nanometer by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723806Antiproliferative activity against human MDA-MB-231 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID654536Cytotoxicity against human Hep3B cells after 6 days by MTT assay2012Journal of natural products, Feb-24, Volume: 75, Issue:2
Bioactive hydroanthraquinones and anthraquinone dimers from a soft coral-derived Alternaria sp. fungus.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1687662Antitumor activity against human MGC-803 cells xenografted in BALB/C nude mouse assessed as tumor growth inhibition at 10 mg/kg, ip administered every 2 days and measured 3 times per week for 16 days
AID1888644Cytotoxicity against human Huh-7 cells assessed as inhibition of cell proliferation measured after 68 hrs by MTT assay2022Journal of natural products, 03-25, Volume: 85, Issue:3
Discovery, Structure Correction, and Biosynthesis of Actinopyrones, Cytotoxic Polyketides from the Deep-Sea Hydrothermal-Vent-Derived
AID1543177Cytotoxicity in human SNB19 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay
AID1328351Cytotoxicity against human HepG2 cells assessed as decrease in cell viability after 72 hrs by MTS assay2016Journal of natural products, 09-23, Volume: 79, Issue:9
Cytotoxic and Antibacterial Preussomerins from the Mangrove Endophytic Fungus Lasiodiplodia theobromae ZJ-HQ1.
AID723805Antiproliferative activity against human DU145 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID683334Cytotoxicity against human NCI-H446 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID430019Antiproliferative activity against MRP1-expressing human DLKP cells assessed as cell proliferation at 0.01 uM after 5 days by acid phosphatase assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis, structural characterisation and biological evaluation of fluorinated analogues of resveratrol.
AID1611346Binding affinity to human telomeric 22 G-quadruplex DNA assessed as binding constant in presence of NaCl by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID1611347Binding affinity to human telomeric 22 G-quadruplex DNA assessed as binding constant in presence of KCl by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611331Binding affinity to human telomeric 7 G-quadruplex DNA assessed as melting temperature Tm2 compound:DNA ratio of 2:0 by CD spectroscopy analysis (Rvb = 64.3 +/- 0.2 degreeC)2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID430029Antiproliferative activity against P-gp expressing human DLKP-A cells assessed as cell proliferation at 1.5 uM after 5 days by acid phosphatase assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis, structural characterisation and biological evaluation of fluorinated analogues of resveratrol.
AID1611329Binding affinity to human telomeric 7 G-quadruplex DNA assessed as delta Tm1 compound:DNA ratio of 0:5 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611317Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 at 559.5 nanometer by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611348Binding affinity to Tetrahymena thermophila telomeric 22 G-quadruplex DNA assessed as binding constant Kb12019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID683330Cytotoxicity against human HepG2 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1354667Cytotoxicity against human HepG2 cells after 48 hrs by MTT assay2018Journal of natural products, 05-25, Volume: 81, Issue:5
Cytotoxic Anthracycline Metabolites from a Recombinant Streptomyces.
AID683808Cytotoxicity against human H460 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1888642Cytotoxicity against human MDA-MB-231 cells assessed as inhibition of cell proliferation measured after 68 hrs by MTT assay2022Journal of natural products, 03-25, Volume: 85, Issue:3
Discovery, Structure Correction, and Biosynthesis of Actinopyrones, Cytotoxic Polyketides from the Deep-Sea Hydrothermal-Vent-Derived
AID1611324Binding affinity to human telomeric 7 G-quadruplex DNA assessed as melting temperature compound:DNA ratio of 1:0 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1543176Cytotoxicity in human MDA-MB-231 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay
AID1611322Effect on parallel topology of human telomeric 7 G-quadruplex DNA assessed as reduction in negative band ellipticity at 264 nm at compound:DNA ratio of 4:0 by CD spectroscopy relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1354664Cytotoxicity against human NCI-H460 cells after 48 hrs by MTT assay2018Journal of natural products, 05-25, Volume: 81, Issue:5
Cytotoxic Anthracycline Metabolites from a Recombinant Streptomyces.
AID1687660Antitumor activity against human MGC-803 cells xenografted in BALB/C nude mouse assessed as tumor growth inhibition at 10 mg/kg, ip administered every 2 days and measured 3 times per week
AID1611307Binding affinity to human telomeric 7 G-quadruplex DNA assessed as drug-DNA complex stoichiometry ratio of 2:1 at 7 uM by absorption spectroscopy2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611326Binding affinity to human telomeric 7 G-quadruplex DNA assessed as change in melting temperature compound:DNA ratio of 2:0 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1498568Anticancer activity against human SGC7901 cells after 72 hrs by MTT assay2018Bioorganic & medicinal chemistry letters, 08-01, Volume: 28, Issue:14
Synthesis and antitumor activity of novel 6,7,8-trimethoxy N-aryl-substituted-4-aminoquinazoline derivatives.
AID683807Cytotoxicity against human LTEP-A2 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1611327Binding affinity to human telomeric 7 G-quadruplex DNA assessed as melting temperature Tm1 compound:DNA ratio of 0:5 by CD spectroscopy analysis (Rvb = 58.8 +/- 0.4 degreeC)2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1888647Cytotoxicity against human MDA-MB-435 cells assessed as inhibition of cell proliferation measured after 68 hrs by MTT assay2022Journal of natural products, 03-25, Volume: 85, Issue:3
Discovery, Structure Correction, and Biosynthesis of Actinopyrones, Cytotoxic Polyketides from the Deep-Sea Hydrothermal-Vent-Derived
AID1687601Cytotoxicity against human T-24 cells expressing wild type p53 assessed as reduction in cell viability preincubated for 48 hrs and measured after 4 hrs by MTT assay
AID601143Cytotoxicity against human MCF7 cells after 6 days by MTT method2011Journal of natural products, May-27, Volume: 74, Issue:5
Cytotoxic norsesquiterpene peroxides from the endophytic fungus Talaromyces flavus isolated from the mangrove plant Sonneratia apetala.
AID1437080Cytotoxicity against human MDA-MB-435 cells assessed as growth inhibition after 48 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Alkaloids from the mangrove endophytic fungus Diaporthe phaseolorum SKS019.
AID681170TP_TRANSPORTER: drug resistance in MRP1-expressing HEK293 cells2003Drug metabolism and disposition: the biological fate of chemicals, Aug, Volume: 31, Issue:8
Molecular cloning and pharmacological characterization of rat multidrug resistance protein 1 (mrp1).
AID1565529Cell cycle arrest in rat C6 cells assessed as decrease in cell population at S phase measured after 24 hrs by propidium iodide staining based flow cytometry analysis2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Structural tuning of acridones for developing anticancer agents targeting dihydrofolate reductase.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1354663Cytotoxicity against human MDA-MB-435 cells after 48 hrs by MTT assay2018Journal of natural products, 05-25, Volume: 81, Issue:5
Cytotoxic Anthracycline Metabolites from a Recombinant Streptomyces.
AID1611354Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 in water by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID723800Antiproliferative activity against mouse fibroblasts after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1543179Cytotoxicity in human NCI-H460 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay
AID1611357Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 in absence of KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1354666Cytotoxicity against human HCT116 cells after 48 hrs by MTT assay2018Journal of natural products, 05-25, Volume: 81, Issue:5
Cytotoxic Anthracycline Metabolites from a Recombinant Streptomyces.
AID1611362Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 in 150 mM of KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611313Binding affinity to human telomeric 7 G-quadruplex DNA assessed as red shift in emission wavelength at 7 uM measured at 591 nanometer by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1328350Cytotoxicity against human A549 cells assessed as decrease in cell viability after 72 hrs by MTS assay2016Journal of natural products, 09-23, Volume: 79, Issue:9
Cytotoxic and Antibacterial Preussomerins from the Mangrove Endophytic Fungus Lasiodiplodia theobromae ZJ-HQ1.
AID1543178Cytotoxicity in human HCT116 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay
AID1611314Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 at 591 nanometer by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID679992TP_TRANSPORTER: drug resistance in MRP1-expressing HEK293 cells1997Molecular pharmacology, Sep, Volume: 52, Issue:3
Pharmacological characterization of the murine and human orthologs of multidrug-resistance protein in transfected human embryonic kidney cells.
AID1437084Cytotoxicity against human MCF10A cells assessed as growth inhibition after 48 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Alkaloids from the mangrove endophytic fungus Diaporthe phaseolorum SKS019.
AID1611328Binding affinity to human telomeric 7 G-quadruplex DNA assessed as melting temperature Tm1 compound:DNA ratio of 2:0 by CD spectroscopy analysis (Rvb = 58.8 +/- 0.4 degreeC)2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID353161Binding affinity to DNA d-(CGATCG)2 at drug to DNA ratio of 2:1 by time resolved fluorescence measurements2009Bioorganic & medicinal chemistry, Apr-01, Volume: 17, Issue:7
Solution studies on the complex of 4'-epiadriamycin-d-(CGATCG)2 followed by time-resolved fluorescence measurement, diffusion ordered spectroscopy and restrained molecular dynamics simulations.
AID1611319Binding affinity to human telomeric 7 G-quadruplex DNA assessed as quenching constant by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1543180Cytotoxicity in human PC3 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay
AID1611349Binding affinity to Tetrahymena thermophila telomeric 22 G-quadruplex DNA assessed as binding constant Kb22019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723803Antiproliferative activity against human A549 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1611333Binding affinity to human telomeric 7 G-quadruplex DNA assessed as melting temperature Tm3 compound:DNA ratio of 0:5 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID103085Compound was tested for its toxicity against doxorubicin resistant human breast cancer cells (MCF-7/ADR).1998Journal of medicinal chemistry, Apr-09, Volume: 41, Issue:8
Epidoxoform: a hydrolytically more stable anthracycline-formaldehyde conjugate toxic to resistant tumor cells.
AID1611363Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 in 100 mM KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611323Binding affinity to human telomeric 7 G-quadruplex DNA by CD spectroscopy2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID654534Cytotoxicity against human PC3 cells after 6 days by MTT assay2012Journal of natural products, Feb-24, Volume: 75, Issue:2
Bioactive hydroanthraquinones and anthraquinone dimers from a soft coral-derived Alternaria sp. fungus.
AID1611350Binding affinity to human telomeric 7 G-quadruplex DNA assessed as stern-volmer quenching constant in compound:DNA ratio of 1.2 to 3.8 by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611336Binding affinity to human telomeric 7 G-quadruplex DNA assessed as hypochromic red shift at 7 uM in presence of 100 to 150 mM K+ ion by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1888645Cytotoxicity against human NCI-H460 cells assessed as inhibition of cell proliferation measured after 68 hrs by MTT assay2022Journal of natural products, 03-25, Volume: 85, Issue:3
Discovery, Structure Correction, and Biosynthesis of Actinopyrones, Cytotoxic Polyketides from the Deep-Sea Hydrothermal-Vent-Derived
AID1328352Cytotoxicity against human HeLa cells assessed as decrease in cell viability after 72 hrs by MTS assay2016Journal of natural products, 09-23, Volume: 79, Issue:9
Cytotoxic and Antibacterial Preussomerins from the Mangrove Endophytic Fungus Lasiodiplodia theobromae ZJ-HQ1.
AID353163Binding affinity to DNA d-(CGATCG)2 assessed as rate of diffusion by diffusion ordered spectroscopy study2009Bioorganic & medicinal chemistry, Apr-01, Volume: 17, Issue:7
Solution studies on the complex of 4'-epiadriamycin-d-(CGATCG)2 followed by time-resolved fluorescence measurement, diffusion ordered spectroscopy and restrained molecular dynamics simulations.
AID1611303Self aggregation behaviour in phosphate buffer solution assessed as effect on absorption spectra at >10 uM by absorption spectroscopy2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1498575Induction of morphological changes in human SGC7901 cells assessed as induction of cell break at 1 and 10 uM after 24 to 72 hrs by inverted microscopic analysis2018Bioorganic & medicinal chemistry letters, 08-01, Volume: 28, Issue:14
Synthesis and antitumor activity of novel 6,7,8-trimethoxy N-aryl-substituted-4-aminoquinazoline derivatives.
AID1611361Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 in 150 mM of KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611304Binding affinity to human telomeric 7 G-quadruplex DNA assessed as hypochromic red shift at 7 uM by absorption spectroscopy relative to untreated control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID683806Cytotoxicity against human DU145 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1611320Effect on parallel topology of human telomeric 7 G-quadruplex DNA assessed as reduction in negative band ellipticity at compound:DNA ratio of 3:0 by CD spectroscopy relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723801Antiproliferative activity against mouse NIH/3T3 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1687602Cytotoxicity against human MGC-803 cells expressing mutant type p53 assessed as reduction in cell viability preincubated for 48 hrs and measured after 4 hrs by MTT assay
AID430017Antiproliferative activity against P-gp expressing human DLKP-A cells assessed as cell proliferation at 0.01 uM after 5 days by acid phosphatase assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis, structural characterisation and biological evaluation of fluorinated analogues of resveratrol.
AID624640Drug glucuronidation reaction catalyzed by human recombinant UGT2B72005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1611352Binding affinity to human telomeric 7 G-quadruplex DNA at compound:DNA ratio of 2.3 to 6.1 by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID683804Cytotoxicity against human HCT116 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID430027Antiproliferative activity against human HT144 cells assessed as cell proliferation at 0.005 uM after 5 days by acid phosphatase assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Synthesis, structural characterisation and biological evaluation of fluorinated analogues of resveratrol.
AID681609TP_TRANSPORTER: drug resistance in MRP1-expressing PEAKSTABEL cells2003Molecular cancer therapeutics, Mar, Volume: 2, Issue:3
Cloning and functional characterization of the multidrug resistance-associated protein (MRP1/ABCC1) from the cynomolgus monkey.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1687606Cytotoxicity against human HL-7702 cells expressing wild type p53 assessed as reduction in cell viability preincubated for 48 hrs and measured after 4 hrs by MTT assay
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID723807Antiproliferative activity against human T47D cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID683805Cytotoxicity against human OVCAR3 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1611321Effect on parallel topology of human telomeric 7 G-quadruplex DNA assessed as reduction in negative band ellipticity at compound:DNA ratio of 4:0 by CD spectroscopy relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611310Binding affinity to human telomeric 7 G-quadruplex DNA assessed as fluorescence quenching at 7 uM measured at 559.5 nanometer by fluorescence spectral analysis relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1185875Cytotoxicity against human HeLa cells assessed as cell viability at 10 uM by SRB assay2014Bioorganic & medicinal chemistry letters, Aug-15, Volume: 24, Issue:16
Five new quassinoids and cytotoxic constituents from the roots of Eurycoma longifolia.
AID1611351Binding affinity to human telomeric 7 G-quadruplex DNA at compound:DNA ratio of 0.4 to 1.0 by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723540Cytotoxicity against human MCF7 cells assessed as change in cell viability at 5 uM after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1611334Binding affinity to human telomeric 7 G-quadruplex DNA assessed as delta Tm3 compound:DNA ratio of 2:0 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611311Binding affinity to human telomeric 7 G-quadruplex DNA assessed as fluorescence quenching at 7 uM measured at 591 nanometer by fluorescence spectral analysis relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723804Antiproliferative activity against human PC3 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1565528Cell cycle arrest in rat C6 cells assessed as increase in cell population at sub G0 phase measured after 24 hrs by propidium iodide staining based flow cytometry analysis2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Structural tuning of acridones for developing anticancer agents targeting dihydrofolate reductase.
AID1611360Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 in 50 mM of KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID477295Octanol-water partition coefficient, log P of the compound2010European journal of medicinal chemistry, Apr, Volume: 45, Issue:4
QSPR modeling of octanol/water partition coefficient of antineoplastic agents by balance of correlations.
AID683802Cytotoxicity against human Bcap37 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1185872Cytotoxicity against human A549 cells assessed as cell viability at 10 uM by SRB assay2014Bioorganic & medicinal chemistry letters, Aug-15, Volume: 24, Issue:16
Five new quassinoids and cytotoxic constituents from the roots of Eurycoma longifolia.
AID679152TP_TRANSPORTER: drug resistance in Mrp1-expressing HEK293 cells1997Molecular pharmacology, Sep, Volume: 52, Issue:3
Pharmacological characterization of the murine and human orthologs of multidrug-resistance protein in transfected human embryonic kidney cells.
AID1328354Cytotoxicity against HEK293T cells assessed as decrease in cell viability after 72 hrs by MTS assay2016Journal of natural products, 09-23, Volume: 79, Issue:9
Cytotoxic and Antibacterial Preussomerins from the Mangrove Endophytic Fungus Lasiodiplodia theobromae ZJ-HQ1.
AID1611340Binding affinity to human telomeric 7 G-quadruplex DNA assessed as hypochromic red shift at 7 uM in presence of 100 mM NaCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723802Antiproliferative activity against human HepG2 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1687605Cytotoxicity against human A549 cells expressing wild type p53 assessed as reduction in cell viability preincubated for 48 hrs and measured after 4 hrs by MTT assay
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1437081Cytotoxicity against human HepG2 cells assessed as growth inhibition after 48 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Alkaloids from the mangrove endophytic fungus Diaporthe phaseolorum SKS019.
AID1611318Binding affinity to human telomeric 7 G-quadruplex DNA assessed as stern-volmer quenching constant in compound:DNA ratio of 0.4 to 1.0 by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID601145Cytotoxicity against human HepG2 after 6 days by MTT method2011Journal of natural products, May-27, Volume: 74, Issue:5
Cytotoxic norsesquiterpene peroxides from the endophytic fungus Talaromyces flavus isolated from the mangrove plant Sonneratia apetala.
AID1678848Cytotoxicity against human MCF7 cells incubated for 72 hrs by SRB assay2020RSC medicinal chemistry, Jun-01, Volume: 11, Issue:6
Breast cancer: insights in disease and influence of drug methotrexate.
AID723538Cytotoxicity against human T47D cells assessed as change in cell viability at 5 uM after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1611309Binding affinity to human telomeric 7 G-quadruplex DNA assessed as fluorescence quenching at 7 uM by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID683332Cytotoxicity against human A549 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1687604Cytotoxicity against human PC-3 cells assessed as reduction in cell viability preincubated for 48 hrs and measured after 4 hrs by MTT assay
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1888643Cytotoxicity against human HT-29 cells assessed as inhibition of cell proliferation measured after 68 hrs by MTT assay2022Journal of natural products, 03-25, Volume: 85, Issue:3
Discovery, Structure Correction, and Biosynthesis of Actinopyrones, Cytotoxic Polyketides from the Deep-Sea Hydrothermal-Vent-Derived
AID1543175Cytotoxicity in human MDA-MB-435 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay
AID1611356Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 in 100 mM NaCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611364Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb2 in 100 mM KCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611338Binding affinity to human telomeric 7 G-quadruplex DNA assessed as hypochromic red shift at 7 uM in presence of water by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1437082Cytotoxicity against human HCT116 cells assessed as growth inhibition after 48 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Alkaloids from the mangrove endophytic fungus Diaporthe phaseolorum SKS019.
AID683800Cytotoxicity against human MKN45 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1437083Cytotoxicity against human NCI-H460 cells assessed as growth inhibition after 48 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Alkaloids from the mangrove endophytic fungus Diaporthe phaseolorum SKS019.
AID601147Cytotoxicity against human PC3 cells after 6 days by MTT method2011Journal of natural products, May-27, Volume: 74, Issue:5
Cytotoxic norsesquiterpene peroxides from the endophytic fungus Talaromyces flavus isolated from the mangrove plant Sonneratia apetala.
AID1611332Binding affinity to human telomeric 7 G-quadruplex DNA assessed as delta Tm2 compound:DNA ratio of 2:0 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1687603Cytotoxicity against human DU145 cells expressing mutant type p53 assessed as reduction in cell viability preincubated for 48 hrs and measured after 4 hrs by MTT assay
AID683801Cytotoxicity against human MCF7 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1611308Binding affinity to human telomeric 7 G-quadruplex DNA incubated for 5 mins by UV-visible spectrophotometric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID683333Cytotoxicity against human NCI-H157 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1611305Binding affinity to human telomeric 7 G-quadruplex DNA assessed as hypochromic red shift by measuring difference in maximum absorption at 7 uM by absorption spectroscopy2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1611353Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 in water by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1611337Binding affinity to human telomeric 7 G-quadruplex DNA assessed as fluorescence quenching at 7 uM in presence of water by fluorescence spectral analysis relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1354665Cytotoxicity against human MDA-MB-231 cells after 48 hrs by MTT assay2018Journal of natural products, 05-25, Volume: 81, Issue:5
Cytotoxic Anthracycline Metabolites from a Recombinant Streptomyces.
AID654535Cytotoxicity against human HepG2 cells after 6 days by MTT assay2012Journal of natural products, Feb-24, Volume: 75, Issue:2
Bioactive hydroanthraquinones and anthraquinone dimers from a soft coral-derived Alternaria sp. fungus.
AID654532Cytotoxicity against human HCT116 cells after 6 days by MTT assay2012Journal of natural products, Feb-24, Volume: 75, Issue:2
Bioactive hydroanthraquinones and anthraquinone dimers from a soft coral-derived Alternaria sp. fungus.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID723808Antiproliferative activity against human MCF7 cells after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1611316Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 at 559.5 nanometer by spectrofluorimetric analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID723539Cytotoxicity against drug-resistant human MDA-MB-231 cells assessed as change in cell viability at 5 uM after 48 hrs by MTT assay2013European journal of medicinal chemistry, Feb, Volume: 60Discovery of coumarin-monastrol hybrid as potential antibreast tumor-specific agent.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID683335Cytotoxicity against human SGC7901 cells after 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Oct-01, Volume: 22, Issue:19
13,28-Epoxy triterpenoid saponins from Ardisia japonica selectively inhibit proliferation of liver cancer cells without affecting normal liver cells.
AID1145600Toxicity in mouse allografted with mouse Sarcoma 180 cells assessed as mortality at >5 mg/kg, ip on day 1 post challenge1976Journal of medicinal chemistry, May, Volume: 19, Issue:5
Stereocontrolled glycosidation of daunomycinone. Synthesis and biological evaluation of 6-hydroxy-L-arabino analogues of antitumor anthracyclines.
AID353160Binding affinity to DNA d-(CGATCG)2 by NMR study2009Bioorganic & medicinal chemistry, Apr-01, Volume: 17, Issue:7
Solution studies on the complex of 4'-epiadriamycin-d-(CGATCG)2 followed by time-resolved fluorescence measurement, diffusion ordered spectroscopy and restrained molecular dynamics simulations.
AID1611355Binding affinity to human telomeric 7 G-quadruplex DNA assessed as binding constant Kb1 in 100 mM NaCl by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID601144Cytotoxicity against human MDA-MB-435 after 6 days by MTT method2011Journal of natural products, May-27, Volume: 74, Issue:5
Cytotoxic norsesquiterpene peroxides from the endophytic fungus Talaromyces flavus isolated from the mangrove plant Sonneratia apetala.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1611339Binding affinity to human telomeric 7 G-quadruplex DNA assessed as fluorescence quenching at 7 uM in presence of 100 mM NaCl by fluorescence spectral analysis relative to control2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1328353Cytotoxicity against human MCF7 cells assessed as decrease in cell viability after 72 hrs by MTS assay2016Journal of natural products, 09-23, Volume: 79, Issue:9
Cytotoxic and Antibacterial Preussomerins from the Mangrove Endophytic Fungus Lasiodiplodia theobromae ZJ-HQ1.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1611325Binding affinity to human telomeric 7 G-quadruplex DNA assessed as melting temperature compound:DNA ratio of 2:0 to 4:0 by CD spectroscopy analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID353162Binding affinity to DNA d-(CGATCG)2 at drug to DNA ratio of 2:1 by 2D NOESY experiment2009Bioorganic & medicinal chemistry, Apr-01, Volume: 17, Issue:7
Solution studies on the complex of 4'-epiadriamycin-d-(CGATCG)2 followed by time-resolved fluorescence measurement, diffusion ordered spectroscopy and restrained molecular dynamics simulations.
AID103913Compound was tested for its toxicity against human breast cancer cells(MCF-7)1998Journal of medicinal chemistry, Apr-09, Volume: 41, Issue:8
Epidoxoform: a hydrolytically more stable anthracycline-formaldehyde conjugate toxic to resistant tumor cells.
AID1611312Binding affinity to human telomeric 7 G-quadruplex DNA assessed as red shift in emission wavelength at 7 uM measured at 559.5 nanometer by fluorescence spectral analysis2019Bioorganic & medicinal chemistry, 12-15, Volume: 27, Issue:24
Dual mode of binding of anti cancer drug epirubicin to G-quadruplex [d-(TTAGGGT)]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID601146Cytotoxicity against human HeLa cells after 6 days by MTT method2011Journal of natural products, May-27, Volume: 74, Issue:5
Cytotoxic norsesquiterpene peroxides from the endophytic fungus Talaromyces flavus isolated from the mangrove plant Sonneratia apetala.
AID1687663Toxicity against BALB/c nude mouse xenografted with human MGC-803 cells assessed as body weight at 10 mg/kg, ip administered every 2 days and measured 3 times per week for 16 days
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347414qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Secondary screen by immunofluorescence2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1347140qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D viability screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347139qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D viability screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347141qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D viability screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347137qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D viability screen for Daoy cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347138qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D caspase screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347136qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D viability screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347135qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Orthogonal 3D viability screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,992)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990344 (6.89)18.7374
1990's1351 (27.06)18.2507
2000's1555 (31.15)29.6817
2010's1462 (29.29)24.3611
2020's280 (5.61)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 63.59

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index63.59 (24.57)
Research Supply Index8.89 (2.92)
Research Growth Index4.97 (4.65)
Search Engine Demand Index113.37 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (63.59)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,838 (33.71%)5.53%
Reviews285 (5.23%)6.00%
Case Studies512 (9.39%)4.05%
Observational27 (0.50%)0.25%
Other2,791 (51.18%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (404)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria [NCT01222052]Phase 34,150 participants (Actual)Interventional2002-01-31Active, not recruiting
A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer [NCT05681728]Phase 226 participants (Anticipated)Interventional2022-02-01Recruiting
HYMN: A Randomized Controlled Phase III Trial Comparing Hyperthermia Plus Mitomycin to a Second Course of Bacillus Calmette-Guerin or Standard Therapy in Patients With Recurrence of Non-Muscle Invasive Bladder Cancer Following Induction or Maintenance Bac [NCT01094964]Phase 3242 participants (Anticipated)Interventional2009-10-31Recruiting
A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer [NCT01199432]Phase 4501 participants (Anticipated)Interventional2010-10-31Completed
A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells [NCT01779050]Phase 27 participants (Actual)Interventional2013-12-19Terminated(stopped due to Loss of study funding)
Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients: a One-arm, Multi-center, Prospective Clinical Trial [NCT03815474]Phase 247 participants (Anticipated)Interventional2019-05-20Recruiting
A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomac [NCT01216644]Phase 2/Phase 3716 participants (Actual)Interventional2010-08-31Completed
A Phase I, Single Center, Open-label, Dose Escalation Study of Recombinant Human Granulocyte Colony-stimulating Factor Fc Fusion Protein (F-627) in Breast Cancer Patient Receiving Adjuvant Chemotherapy [NCT02527746]Phase 1/Phase 218 participants (Actual)Interventional2012-12-31Completed
A Phase IB/II Study of Durvalumab (MEDI4736) Combined With Dose-dense EC in a Neoadjuvant Setting for Patients With Locally Advanced Luminal B HER2(-) or Triple Negative Breast Cancers. [NCT03356860]Phase 1/Phase 257 participants (Actual)Interventional2017-04-13Active, not recruiting
Molecular Triaging of Newly Diagnosed Breast Cancer for Preoperative Therapies [NCT01159236]0 participants (Actual)Interventional2010-09-30Withdrawn(stopped due to Recent developments lead to re-evaluation of study.)
Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial [NCT05834582]Phase 260 participants (Anticipated)Interventional2023-04-08Recruiting
A Randomized Phase II Study of Chemotherapy ± Metformin in Metastatic Pancreatic Cancer [NCT01167738]Phase 260 participants (Actual)Interventional2010-07-31Terminated(stopped due to concern of detrimental effect)
Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.) [NCT01301040]Phase 22 participants (Actual)Interventional2011-03-31Terminated(stopped due to Slow recruitment)
A Randomized Study Evaluating the Safety and Effects of the Combination of Palbociclib With Epirubicin and Cyclophosphamide Followed by Paclitaxel as Neoadjuvant Therapy in Triple Negative Breast Cancer [NCT03756090]100 participants (Anticipated)Interventional2018-12-01Not yet recruiting
A Phase II Study of Temozolomide for Injection Combined With Epirubicin in the First-line Treatment of Leiomyosarcoma [NCT05204524]28 participants (Anticipated)Interventional2021-08-27Recruiting
A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy [NCT00066807]Phase 329 participants (Actual)Interventional2003-08-31Terminated(stopped due to Poor accrual, patients were followed until completion of 5 yrs treatment)
Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes [NCT01134523]Phase 31,000 participants (Anticipated)Interventional2010-05-31Recruiting
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma [NCT01327521]Phase 30 participants (Actual)Interventional2011-02-28Withdrawn(stopped due to Accrual below target levels)
Effectiveness of First Line Treatment With Lapatinib and ECF/X in Histologically Proven Adenocarcinoma of the Stomach or the Esophagogastric Junction, Metastatic or Not Amenable to Curative Surgery According to HER2 and EGFR Status: a Randomized Phase II [NCT01123473]Phase 229 participants (Actual)Interventional2010-12-31Terminated(stopped due to company withdrew interest)
Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture [NCT03925233]300 participants (Anticipated)Observational2019-01-02Enrolling by invitation
An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Ri [NCT01204437]Phase 2/Phase 3400 participants (Actual)Interventional2009-03-31Completed
Randomized Study of Efficacy & Safety of Lapatinib & Epirubicin & Cyclophosphamide (EC90) Followed by Paclitaxel & Lapatinib Compared With EC90 Followed by Paclitaxel & Trastuzumab, as Neoadjuvant Therapy in Patients With Previously Untreated ErbB2-overex [NCT01205217]Phase 20 participants (Actual)Interventional2010-12-31Withdrawn(stopped due to Data presented at SABCS 2010 showing that dual blockade is superior to monotherapy)
A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma [NCT01351038]Phase 243 participants (Anticipated)InterventionalTerminated(stopped due to REAL trial showed a significant difference in OS for reduced EOX and standard EOX)
A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer [NCT05420467]Phase 42,413 participants (Anticipated)Interventional2022-07-10Recruiting
Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos [NCT03668418]120 participants (Anticipated)Observational2018-06-01Recruiting
Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer. [NCT01378533]Phase 3100 participants (Anticipated)Interventional2011-05-31Recruiting
Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in HER2-negative Operable Breast [NCT01314833]Phase 31,570 participants (Actual)Interventional2010-06-01Completed
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer [NCT03647280]50 participants (Anticipated)Interventional2018-12-01Not yet recruiting
Clinical Study of PD-1 Monoclonal Antibody SHR-1210 Combined With Epirubicin in the Treatment of Extensive Small Cell Lung Cancer After First-line Treatment Failure [NCT03755115]Phase 240 participants (Anticipated)Interventional2019-02-01Not yet recruiting
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Clinical Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk C [NCT04490993]Phase 3359 participants (Actual)Interventional2017-03-30Active, not recruiting
Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer [NCT02115152]Phase 2100 participants (Anticipated)Interventional2014-06-30Not yet recruiting
A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Po [NCT01966471]Phase 31,846 participants (Actual)Interventional2014-01-31Completed
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial. [NCT02177552]Phase 298 participants (Anticipated)Interventional2014-06-30Active, not recruiting
A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL) [NCT01148446]Phase 3226 participants (Actual)Interventional2003-01-31Completed
Randomized Phase II-III Trial of Peri- or Post-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma [NCT01150630]Phase 298 participants (Actual)Interventional2010-05-31Completed
A Multicenter, Randomized, Double-blind, Prospective Study to Evaluate the Efficacy and Safety of Vincristine, Dactinomycin/Cyclophosphamide Combination Therapy Combined With Liposomal Doxorubicin/Doxorubicin/Pharmorubicin/Pirarubicin in 0.5-14 Year Old C [NCT03892330]Phase 4120 participants (Anticipated)Interventional2019-06-01Not yet recruiting
Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer With Homologous Recombination Repair Deficiency [NCT03876886]Phase 3200 participants (Anticipated)Interventional2019-02-22Recruiting
Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients [NCT00129922]Phase 31,289 participants (Actual)Interventional1999-11-30Completed
Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL) [NCT05024734]Phase 233 participants (Anticipated)Interventional2022-11-17Recruiting
A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC) [NCT05447702]Phase 235 participants (Anticipated)Interventional2022-11-01Recruiting
Dose-dense Epirubicin Hydrochloride With Cyclophosphamide Followed by Nanoparticlealbumin-bound Paclitaxel With PD-1 Regimen in Neoadjuvant Therapy for Patients With Triple-negative Breast Cancer [NCT04418154]Phase 270 participants (Actual)Interventional2020-06-09Active, not recruiting
Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers [NCT02324088]Phase 3174 participants (Actual)Interventional2000-10-31Completed
Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy [NCT01710176]Phase 3550 participants (Actual)Interventional2011-06-01Active, not recruiting
A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer [NCT02207361]Phase 4120 participants (Anticipated)Interventional2013-12-31Recruiting
Neoadjuvant Pyrotinib Versus Placebo Combined With Chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) Early Breast Cancer: a Double Blind, Multi-center, Randomized Phase III Trial [NCT06144944]Phase 3160 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer [NCT01779206]Phase 2/Phase 34,936 participants (Anticipated)Interventional2012-05-31Active, not recruiting
A Prospective Phase III Randomized Clinical Trial Comparing the Effectiveness of Immediate Postoperative Intravesical Instillation With Either Gemcitabine Hydrochloride or Epirubicin Hydrochloride in Patients With Urinary Bladder Cancer (Gemcitabine Epiru [NCT04947059]Phase 3180 participants (Anticipated)Interventional2021-12-14Recruiting
Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction [NCT02287129]Phase 275 participants (Actual)Interventional2014-12-05Completed
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, [NCT03192644]Phase 3162 participants (Anticipated)Interventional2017-07-01Recruiting
Phase I-II Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas [NCT03277924]Phase 1/Phase 2270 participants (Anticipated)Interventional2017-05-31Recruiting
A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer [NCT02076594]Phase 3171 participants (Actual)Interventional2013-01-31Terminated(stopped due to The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.)
A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy [NCT04437160]Phase 2286 participants (Anticipated)Interventional2020-02-01Recruiting
Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma [NCT00057980]Phase 1/Phase 28 participants (Actual)Interventional2002-10-31Completed
Adjuvant Chemotherapy of Breast Cancer: Sequential Chemotherapy vs. Standard Therapy. Prospective Randomised Comparison of 4 x Epirubicin and Cyclophosphamide (EC) --> 4 x Docetaxel (Doc) vs. 6 x CMF / CEF in Patients With 1 to 3 Positive Lymph Nodes [NCT02115204]Phase 32,011 participants (Actual)Interventional2000-06-30Completed
Open-label, Randomized, Multicenter, International, Parallel Exploratory Phase II Study, Comparing 3 FEC-3 Docetaxel Chemotherapy to Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk [NCT02400567]Phase 2125 participants (Actual)Interventional2015-01-31Completed
A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients [NCT01210768]Phase 2254 participants (Anticipated)Interventional2010-06-30Active, not recruiting
A Randomized Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto) [NCT02125344]Phase 3961 participants (Actual)Interventional2014-12-31Completed
Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups [NCT00005584]Phase 31,649 participants (Actual)Interventional1998-10-31Active, not recruiting
A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer. [NCT02225652]Phase 211 participants (Actual)Interventional2010-09-30Completed
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, an [NCT00719550]Phase 1/Phase 2130 participants (Actual)Interventional2009-02-28Completed
The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train. [NCT05816694]Phase 250 participants (Anticipated)Interventional2023-04-30Not yet recruiting
The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial [NCT03123770]Phase 4384 participants (Anticipated)Interventional2016-12-31Recruiting
An Open Label Randomized Controlled Phase II Trial of Panitumumab in Combination With Epirubicin, Cisplatin and Capecitabine (ECX) Versus ECX Alone in Subjects With Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction. [NCT01234324]Phase 2171 participants (Actual)Interventional2010-10-31Completed
Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma [NCT02630108]Phase 3280 participants (Anticipated)Interventional2015-12-31Recruiting
ARTemis - Avastin Randomized Trial With Neo-Adjuvant Chemotherapy for Patients With Early Breast Cancer [NCT01093235]Phase 3800 participants (Anticipated)Interventional2009-04-30Recruiting
An Open-Label Phase I/II Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer [NCT05981014]Phase 1/Phase 2196 participants (Anticipated)Interventional2023-08-01Recruiting
Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China [NCT02631499]Phase 4256 participants (Anticipated)Interventional2015-12-31Not yet recruiting
A Prospective, Randomized, Open-label, Multicentric,phaseIII Clinical Trial Compared With PC and CEF100 Followed by Docetaxel as Adjuvant Chemotherapy Regimen for Chinese Primary Triple Negative Breast Cancer Patients [NCT01216111]Phase 3647 participants (Actual)Interventional2011-01-01Completed
A Phase 2 Trial of Liposomal Doxorubicin and Carboplatin in Patients With ER, PR, HER2 Negative Breast Cancer (TNBC) [NCT02315196]Phase 262 participants (Actual)Interventional2015-02-25Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma [NCT06140966]Phase 254 participants (Anticipated)Interventional2023-10-20Recruiting
A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer [NCT03556358]Phase 3809 participants (Actual)Interventional2018-06-28Completed
Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes [NCT03894007]Phase 26 participants (Actual)Interventional2019-05-23Terminated(stopped due to Security and effect data from another ongoing study.)
A Phase II Randomized, Non-inferiority Study Comparing the Efficacy and Safety of Dalpiciclib Combined With AI With Neoadjuvant Chemotherapy in ER+ HER2- Postmenopausal Breast Cancer Patients [NCT06107673]Phase 2144 participants (Anticipated)Interventional2023-09-30Recruiting
SBG 2000-1. Individually Dose-adjusted FEC Compared to Standard FEC as Adjuvant Chemotherapy for Node Positive or High-risk Node Negative Breast Cancer. A Randomized Study by the Scandinavian Breast Group [NCT03888677]Phase 31,535 participants (Actual)Interventional2001-02-28Completed
Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer [NCT03373708]Phase 2/Phase 3200 participants (Anticipated)Interventional2017-12-20Not yet recruiting
A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer [NCT05420454]Phase 41,576 participants (Anticipated)Interventional2022-07-10Recruiting
A Single Arm, Multi-center, Phase II Clinical Trial of Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma and CD79A/CD79B Genetic Abnormality [NCT04668365]Phase 259 participants (Anticipated)Interventional2020-12-25Recruiting
A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma [NCT04433156]Phase 260 participants (Anticipated)Interventional2020-04-22Recruiting
Phase II Clinical Trial of Camrelizumab Combined With AVD (Epirubicin, Vincristine and Dacarbazine) in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma [NCT04067037]Phase 260 participants (Anticipated)Interventional2019-08-26Recruiting
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer ((ANWENDUNGSBEOBACHTUNG,MOI 99056 -Neo-/Adjuvante Chemotherapie Des Primären Mammakarzinoms Der Frau Mit Farmorubicin®)) [NCT01061359]1,981 participants (Actual)Observational1999-01-31Completed
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER2+Breast Cancer: a Multicenter, Randomized, Open-label, Parallel-Group Controlled Trial [NCT04290793]Phase 2/Phase 3280 participants (Anticipated)Interventional2020-03-01Not yet recruiting
Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study [NCT02871869]Phase 2/Phase 3316 participants (Anticipated)Interventional2016-09-30Recruiting
A Phase I, Open-label, Study of the Safety, Pharmacokinetics, and Pharmacodynamics Dose Escalation of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors [NCT00722293]Phase 1111 participants (Actual)Interventional2008-07-08Completed
Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX) [NCT02682693]Phase 2780 participants (Actual)Interventional2017-02-13Completed
A Controlled Clinic Trial of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Combination With Transcatheter Arterial Chemoembolization in Treating Patients With Advanced Hepatocellular Carcinoma [NCT02638857]Phase 1/Phase 260 participants (Anticipated)Interventional2015-09-30Recruiting
A Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (Phase 1B/2; Protocol No. P04722) [NCT00954512]Phase 1/Phase 215 participants (Actual)Interventional2009-09-25Terminated(stopped due to This study was terminated for business reasons.)
A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC) [NCT00950300]Phase 3596 participants (Actual)Interventional2009-10-16Completed
A Prospective Phase II Randomized, Blinded Study to Demonstrate the Effectiveness of Jobelyn for the Treatment of Breast Cancer Patients. [NCT01936064]Phase 1/Phase 260 participants (Anticipated)Interventional2016-10-31Recruiting
Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer [NCT04031703]Phase 3647 participants (Actual)Interventional2011-01-01Completed
REAL 3 : A Randomised Open-labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-gastric Cancer [NCT00824785]Phase 3574 participants (Actual)Interventional2008-05-31Terminated(stopped due to Lack of efficacy)
Docetaxel-epirubicin Plus Bevacizumab as First Line Therapy for Patients With Metastatic and HER2 Negative Breast Cancer. A Multicenter Phase I-II Study [NCT00705315]Phase 1/Phase 246 participants (Anticipated)Interventional2008-05-31Completed
A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer [NCT00066443]Phase 1/Phase 293 participants (Actual)Interventional2003-11-03Completed
A Pilot Dose Escalation Phase I Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study [NCT02392845]Phase 117 participants (Actual)Interventional2005-06-30Completed
To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induc [NCT05491694]Phase 220 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells [NCT02510781]Phase 2200 participants (Anticipated)Interventional2015-01-31Recruiting
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study [NCT02395640]Phase 3438 participants (Anticipated)Interventional2015-03-31Completed
A Prospective, Single Center, Randomized, Open-labled Stage III Clinical Trial Comparing the Efficacy and Safety of Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Foll [NCT04296175]Phase 3808 participants (Anticipated)Interventional2020-03-05Recruiting
Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer [NCT02128243]Phase 2242 participants (Actual)Interventional2014-09-30Completed
Prophylactic Intravesical Chemotherapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Randomized Controlled Trial Between Single Postoperative Dose Versus Maintenance Therapy. [NCT02438865]Phase 274 participants (Actual)Interventional2015-01-01Completed
TACE With Dicycloplatin(TP21) in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial [NCT05472896]Phase 3332 participants (Anticipated)Interventional2022-06-09Recruiting
A Non-inferior, Randomized Controlled Phase III Clinical Study Comparing the Efficacy of TCbHPand ECHP-THP in Neoadjuvant Treatment of Operable HER2-positive Breast Cancer [NCT05474690]Phase 3456 participants (Anticipated)Interventional2022-05-11Recruiting
Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients [NCT06009627]Phase 2/Phase 3119 participants (Anticipated)Interventional2023-04-11Recruiting
A Multi-center, Randomized, Open-label, Parallel-controlled Phase 3 Clinical Trial to Evaluate the Clinical Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate [NCT04736394]Phase 3800 participants (Anticipated)Interventional2021-09-29Recruiting
A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma [NCT03113955]109 participants (Actual)Interventional2017-10-24Completed
Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen [NCT00454636]Phase 2158 participants (Actual)Interventional2007-03-31Completed
Randomized Phase II-III Trial of Post-operative Treatment of Pancreatic Adenocarcinoma: Gemcitabine Versus PEFG Followed by Radiochemotherapy With Concomitant Continuous Infusion of 5-fluorouracil [NCT00960284]Phase 2/Phase 3102 participants (Actual)Interventional2003-06-30Completed
"A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients" [NCT00432172]Phase 2189 participants (Actual)Interventional2007-04-24Completed
Preoperative Therapy With Epirubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab and Postoperative Therapy With Trastuzumab in Patients With HER-2 Over Expressed Breast Cancer [NCT00795899]Phase 2230 participants (Actual)Interventional2002-01-31Completed
Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer [NCT00820547]Phase 2100 participants (Actual)Interventional2009-01-31Completed
Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer [NCT00381706]Phase 2245 participants (Actual)Interventional2006-09-15Completed
Chemotherapy Plus Lapatinib or Trastuzumab or Both in Her2+ Primary Breast Cancer. A Randomized Phase IIb Study With Biomarker Evaluation. [NCT00429299]Phase 2121 participants (Actual)Interventional2006-08-31Completed
Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression [NCT01036087]Phase 247 participants (Actual)Interventional2010-11-30Completed
Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma [NCT02767674]Phase 3258 participants (Anticipated)Interventional2016-05-31Recruiting
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer [NCT05084586]100 participants (Anticipated)Interventional2019-10-01Recruiting
Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study [NCT00933517]Phase 262 participants (Actual)Interventional2009-09-30Completed
A Phase I Trial of Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients [NCT00486356]Phase 146 participants (Actual)Interventional2004-10-31Completed
Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility [NCT00617370]38 participants (Actual)Interventional2004-11-30Completed
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - [NCT03355157]Phase 4150 participants (Anticipated)Interventional2018-03-01Recruiting
A Randomized Phase II Pilot Study to Evaluate Safety and Efficacy of the Addition of Vismodegib to Standard Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients [NCT02694224]Phase 240 participants (Anticipated)Interventional2016-04-30Recruiting
A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2 [NCT00615602]Phase 3489 participants (Actual)Interventional2004-10-31Completed
SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer [NCT04213898]Phase 1/Phase 239 participants (Anticipated)Interventional2020-01-31Not yet recruiting
Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer [NCT04138719]Phase 2520 participants (Anticipated)Interventional2019-11-20Recruiting
PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial [NCT02624973]Phase 2200 participants (Actual)Interventional2016-04-15Active, not recruiting
A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer [NCT00645866]Phase 247 participants (Anticipated)Interventional2003-04-30Completed
Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+) [NCT00668616]Phase 31,034 participants (Actual)Interventional2000-03-31Completed
A Multi Center, Randomized, Parallel Controlled Study of Applying Transurethral Resection of Bladder Tumor With Adjuvant Cryoablation to Treat Bladder Cancer [NCT02760953]150 participants (Anticipated)Interventional2017-10-19Not yet recruiting
Randomized, Phase III-b, Multi-centre, Open-label, Parallel Study of Enoxaparin (Low Molecular Weight Heparin) Given Concomitantly With Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Gastric and Gastro-oesophageal Cancer [NCT00718354]Phase 3740 participants (Actual)Interventional2008-07-31Completed
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer [NCT01358877]Phase 34,804 participants (Actual)Interventional2011-11-08Active, not recruiting
PROMIX - Preoperative Treatment of Breast Cancer With a Combination of Epirubicin, Docetaxel and Bevacizumab. A Translational Trial on Molecular Markers and Functional Imaging to Predict Response Early. A Phase 2 Study. [NCT00957125]Phase 2151 participants (Actual)Interventional2008-09-30Active, not recruiting
A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma [NCT04214626]Phase 260 participants (Actual)Interventional2020-01-02Active, not recruiting
Open Label Randomized Clinical Trial of Standard Neoadjuvant Chemotherapy (Paclitaxel Followed by FEC) Versus the Combination of Paclitaxel and RAD001 Followed by FEC in Women With Triple Receptor-Negative Breast Cancer (CRAD001C24101) [NCT00499603]Phase 262 participants (Actual)Interventional2007-07-31Active, not recruiting
Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer [NCT00689156]Phase 32,015 participants (Actual)Interventional2008-06-30Completed
A Randomized Phase II Study to Investigate the Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Containing Chemotherapy in Triple Negative Breast Cancer (GeparNuevo) [NCT02685059]Phase 2174 participants (Actual)Interventional2016-06-30Completed
Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy [NCT02641847]Phase 2/Phase 3503 participants (Anticipated)Interventional2015-07-31Recruiting
A Single-center, Randomized, Open-label, Phase III Study Comparing PD-1 Combined With Anthracycline/Taxane-based Adjuvant Chemotherapy and Antivascular Therapy Versus Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer [NCT05862064]Phase 3606 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Pilot Study of Perioperative Panitumumab in Combination With Epirubicin, Oxaliplatin and Xeloda in Patients With Resectable Gastroesophageal Adenocarcinoma [NCT00667420]Phase 1/Phase 217 participants (Actual)Interventional2008-04-30Terminated(stopped due to Closed due to slow accrual)
PANTHER. A Randomized Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel (dtEC→dtT) Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel (FEC→T) in Lymph [NCT00798070]Phase 32,017 participants (Actual)Interventional2007-02-28Active, not recruiting
A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu) [NCT00756470]Phase 215 participants (Actual)Interventional2008-10-31Terminated(stopped due to Slow accrual.)
A Phase II Study of Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma [NCT00737438]Phase 222 participants (Actual)Interventional2008-08-31Completed
An Open-Label Phase I Study of Fixed Dose Lapatinib in Combination With an Escalating Dose of Epirubicin in Metastatic Breast Cancer [NCT00753207]Phase 110 participants (Actual)Interventional2007-10-31Completed
A Randomized, Double-Blind, International Multi-Centre, Phase III Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy Versus Placebo in Combination With C [NCT04301739]Phase 3522 participants (Anticipated)Interventional2020-04-17Not yet recruiting
A Phase 1, Open-Label, Non-Randomized, Dose-Finding, Safety and Tolerability Study of Orally Administered Teysuno (S-1) in Combination With Epirubicin and Oxaliplatin in Patients With Advanced Solid Tumors [NCT02867397]Phase 125 participants (Actual)Interventional2012-01-31Completed
To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study [NCT05656079]204 participants (Anticipated)Interventional2021-07-01Recruiting
A Phase II Trial of Induction Chemotherapy With Epirubicin, Oxaliplatin and Fluorouracil (EOF) Followed by Esophagogastrectomy and Post-operative Concurrent Chemoradiotherapy With Fluorouracil and Cisplatin, in Patients With Loco-regionally Advanced Adeno [NCT00601705]Phase 261 participants (Actual)Interventional2008-01-05Completed
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma [NCT00843934]Phase 2/Phase 3450 participants (Anticipated)Interventional2009-03-31Recruiting
A Randomised Phase II Feasibility Study Investigating the Biological Effects of the Addition of Zoledronic Acid to Neoadjuvant Combination Chemotherapy on Invasive Breast Cancer [NCT00525759]Phase 240 participants (Actual)Interventional2007-07-31Completed
A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients [NCT00433420]Phase 32,000 participants (Anticipated)Interventional2003-04-30Active, not recruiting
An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in [NCT02846428]Phase 2182 participants (Actual)Interventional2004-03-31Completed
A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma [NCT04061772]Phase 254 participants (Anticipated)Interventional2019-08-12Recruiting
Phase II Randomized Clinical Trial and Biomarker Analysis of Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin as Neoadjuvant Chemotherapy in Locally Advanced HER2-Negative Breast Cancer With TEKT4 Variations [NCT02628613]Phase 291 participants (Actual)Interventional2015-12-31Completed
Eastern Hepatobilliary Surgical Hospital [NCT00820053]Phase 2450 participants (Actual)Interventional2009-01-31Completed
A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer [NCT00525642]Phase 2/Phase 3603 participants (Actual)Interventional2003-06-30Active, not recruiting
A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous R [NCT02789332]Phase 2107 participants (Actual)Interventional2016-09-30Completed
Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer [NCT02897050]Phase 2170 participants (Anticipated)Interventional2016-09-30Suspended
A Prospective, Belgian Multi-center, Single-arm, Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer [NCT04224922]Phase 263 participants (Actual)Interventional2015-05-31Completed
Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer [NCT01049425]Phase 33,198 participants (Actual)Interventional2009-02-05Completed
A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer [NCT00743964]Phase 291 participants (Actual)Interventional2008-04-30Completed
Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma [NCT00755976]Phase 232 participants (Actual)Interventional2007-08-31Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma [NCT01697072]Phase 3609 participants (Actual)Interventional2012-10-31Terminated(stopped due to All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.)
Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors [NCT00872625]Phase 126 participants (Actual)Interventional2007-04-30Completed
Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer [NCT01386346]Phase 112 participants (Actual)Interventional2011-06-30Completed
A Randomized Phase III Study Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF to Epirubicin and Docetaxel + G-CSF as Neoadjuvant Treatment for Early HER-2 Negative Breast Cancer and Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF ± Trastu [NCT00309556]Phase 3536 participants (Actual)Interventional2005-02-28Completed
PreOperative Treatment With chEmotheRapy or chemoRAdiatioN in esophaGeal or gastroEsophageal adenocaRcinoma [NCT01404156]Phase 2/Phase 360 participants (Anticipated)Interventional2015-09-30Recruiting
PEXG (Cisplatin, Epirubicin, Capecitabine, Gemcitabine) Versus PDXG (Cisplatin, Docetaxel, Capecitabine, Gemcitabine) in Locally Advanced or Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial [NCT00966706]Phase 2105 participants (Actual)Interventional2005-06-30Completed
A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab [NCT00625898]Phase 33,509 participants (Actual)Interventional2008-04-30Terminated
Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial [NCT04136782]Phase 4110 participants (Anticipated)Interventional2021-07-19Recruiting
A Randomized Phase III Study of Docetaxel/ Epirubicin Versus Tailored Regimens as Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm [NCT00776724]Phase 3166 participants (Actual)Interventional2008-05-29Completed
The Effect of Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab Combined With Pertuzumab: A Single-center Phase II Clinical Study [NCT04255056]Phase 227 participants (Anticipated)Interventional2020-02-01Not yet recruiting
Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma: a Prospective Non-randomized Trial [NCT02755311]Phase 3198 participants (Anticipated)Interventional2014-03-31Recruiting
Phase III Trail of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction [NCT01917578]Phase 34 participants (Anticipated)Interventional2008-08-31Recruiting
A Neoadjuvant Study of Chemotherapy Versus Endocrine Therapy in Postmenopausal Patients With Primary Breast Cancer [NCT00963729]Phase 3756 participants (Anticipated)Interventional2008-09-30Completed
Phase 2 Randomized Study of Different Neoadjuvant Regimens in Subtypes of Breast Cancer [NCT02041338]Phase 2200 participants (Anticipated)Interventional2014-01-31Recruiting
A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine (XELODA) (CEX) As Primary Treatment Of Locally Advanced/Inflammatory Or Large Operable Breast Cancer [NCT00008034]Phase 115 participants (Actual)Interventional2000-02-29Completed
Neoadjuvant Treatment of TEC Versus TEC Plus Metformin in Breast Cancer:A Prospective, Randomized Trial [NCT01929811]Phase 292 participants (Actual)Interventional2013-10-31Terminated(stopped due to Slow enrollment.)
First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane [NCT00017095]Phase 31,856 participants (Actual)Interventional2001-03-31Completed
A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer [NCT00146588]55 participants (Actual)Interventional2002-04-30Completed
A Phase I Trial of Panobinostat (LBH589) and Epirubicin in Patients With Solid Tumor Malignancies [NCT00878904]Phase 140 participants (Actual)Interventional2009-09-13Completed
"A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early Triple Negative Breast Cancer" [NCT04335669]Phase 3920 participants (Anticipated)Interventional2019-12-20Recruiting
Antiangiogenic Potentiation of Preoperative Chemoradiotherapy for High Risk Extremity Soft Tissue Sarcomas: A Phase I Study of Sorafenib With Epirubicin, Ifosfamide, Hypofractionated Radiation, and Surgery [NCT00822848]Phase 118 participants (Actual)Interventional2009-02-28Completed
Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old [NCT01026116]Phase 3521 participants (Actual)Interventional2009-12-31Completed
Adjuvant Treatment of Biologically Aggressive Breast Cancer (N-,N+1,3): Controlled Clinical Study [NCT01031030]Phase 3800 participants (Anticipated)Interventional1997-11-30Active, not recruiting
A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma [NCT01053390]Phase 3216 participants (Actual)Interventional2009-10-31Completed
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab W [NCT06112379]Phase 31,728 participants (Anticipated)Interventional2023-11-14Recruiting
A Multicenter Randomized Phase III Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study) [NCT00407186]Phase 3788 participants (Actual)Interventional2007-01-11Active, not recruiting
A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer [NCT00322374]Phase 142 participants (Actual)Interventional2006-08-31Completed
Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients [NCT00270894]Phase 230 participants (Actual)Interventional2005-11-30Completed
A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) To Four Cycles Of Adriamycin And Cyclophosphamide (AC) In Patients With Node-Negative Breast Cancer [NCT00087178]Phase 32,722 participants (Actual)Interventional2004-05-31Completed
Efficacy & Safety of Bevacizumab as Neoadjuvant Treatment in Patients With Locally Advanced Inflammatory Breast Cancer, a Pilot Study. [NCT01880385]Phase 130 participants (Anticipated)Interventional2011-03-31Recruiting
A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer [NCT00033683]Phase 20 participants Interventional2001-02-28Active, not recruiting
A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY) [NCT01907529]Phase 2/Phase 3300 participants (Anticipated)Interventional2019-08-31Enrolling by invitation
Sequential High-Dose Chemotherapy Combining Two Mobilization and Cyto-Reductive Treatments Followed by Three High-Dose Chemotherapy Regimens Supported by Autologous Stem Cell Transplantation [NCT00231582]Phase 250 participants (Actual)Interventional2004-09-30Completed
The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer [NCT01964027]Phase 240 participants (Anticipated)Interventional2013-10-31Not yet recruiting
A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-supported Sequential Administration of FE75C Followed by Docetaxel Versus Docetaxel/Cyclophosphamide Doublet as Adjuvant Chemotherapy in Women With HER-2 Negative, Axillary Lymph Node Positive [NCT01985724]Phase 3650 participants (Actual)Interventional2007-10-31Completed
Phase II, Open-label Non-randomized Trial to Investigate the Efficacy of Bevacizumab in Combination With Dose Dense Sequential Chemotherapy in the Neo-adjuvant Setting for HER2 Negative Breast Cancer Patients [NCT01985841]Phase 234 participants (Actual)Interventional2011-10-31Terminated(stopped due to Due to poor accrual)
Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer [NCT00253500]Phase 215 participants (Actual)Interventional2002-06-30Completed
A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer [NCT02001506]Phase 3250 participants (Actual)Interventional2012-11-30Completed
Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer:A Prospective, Randomized Trial [NCT02005783]Phase 250 participants (Anticipated)Interventional2013-10-31Completed
A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC) [NCT03036488]Phase 31,174 participants (Actual)Interventional2017-03-07Active, not recruiting
Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer [NCT00604435]Phase 269 participants (Actual)Interventional2008-02-29Completed
Phase III Study to Compare Haplo-identical HSCT Versus Chemotherapy in First Remission for Standard-risk Adult Acute Lymphoblastic Leukemia [NCT02042690]Phase 3131 participants (Actual)Interventional2014-07-31Completed
A Phase III Trials Program Exploring the Integration of Bevacizumab, Everolimus (RAD001), and Lapatinib Into Current Neoadjuvant Chemotherapy Regimes for Primary Breast Cancer [NCT00567554]Phase 32,600 participants (Actual)Interventional2007-10-31Completed
Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer:a Multicenter Randomized Controlled Trial [NCT04576143]Phase 2/Phase 3260 participants (Anticipated)Interventional2020-09-20Recruiting
Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer [NCT00193206]Phase 2123 participants (Actual)Interventional2005-09-30Completed
Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients [NCT00193050]Phase 2110 participants (Actual)Interventional2001-11-30Completed
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive [NCT00556127]Phase 294 participants (Actual)Interventional2002-06-30Completed
The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial [NCT02214602]Phase 4240 participants (Actual)Interventional2014-07-31Completed
Albumin Bound (Nab)-Paclitaxel Combined With Carboplatin Versus Paclitaxel Combined With Carboplatin Followed by Epirubicin and Cyclophosphamide as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) [NCT04067102]0 participants (Actual)Interventional2019-05-10Withdrawn(stopped due to No patients recruited)
[NCT02547350]Phase 2200 participants (Anticipated)Interventional2015-09-30Not yet recruiting
A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer [NCT00912444]Phase 3102 participants (Actual)Interventional2009-07-31Terminated(stopped due to TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.)
Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment [NCT00309920]1,234 participants (Anticipated)Interventional2004-01-31Recruiting
A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer [NCT00658580]Phase 3361 participants (Actual)Interventional2000-04-30Completed
A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas [NCT00669812]Phase 260 participants (Anticipated)Interventional2008-02-29Recruiting
SHORT-HER: MULTICENTRIC RANDOMISED PHASE III TRIAL OF 2 DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENS PLUS 3 VS 12 MONTHS OF TRASTUZUMAB IN HER2 POSITIVE BREAST CANCER PATIENTS [NCT00629278]Phase 32,500 participants (Anticipated)Interventional2007-12-31Recruiting
A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy [NCT02879513]Phase 3290 participants (Anticipated)Interventional2014-01-31Recruiting
[NCT02627248]Phase 4200 participants (Anticipated)Interventional2015-10-31Recruiting
Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer [NCT00540800]Phase 3139 participants (Actual)Interventional2004-02-29Completed
Randomized Comparison of a Preoperative, Dose-Intensified, Interval-Shortened, Sequential Chemotherapy With Epirubicin, Paclitaxel and CMF ± Darbepoetin Alfa Versus a Preoperative, Sequential Chemotherapy With Epirubicin and Cyclophosphamide Followed by P [NCT00544232]Phase 3720 participants (Actual)Interventional2002-08-31Completed
[NCT00544505]10 participants (Anticipated)Interventional2007-09-30Active, not recruiting
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression Profile-Based Test to Select Patients for Preoperative Taxane/Anthracycline Chemotherapy for Stage I-III Breast Cancer [NCT00336791]Phase 3273 participants (Actual)Interventional2003-09-30Completed
[NCT00162695]Phase 3400 participants Interventional1995-07-31Terminated
Multicenter, Randomized, Open-label Phase II Study to Compare the Efficacy and Safety of Trastuzumab and Paclitaxel Based Regimen Plus Carboplatin or Epirubicin as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients [NCT01428414]Phase 2100 participants (Anticipated)Interventional2011-08-31Active, not recruiting
A Phase III Trial to Compare ETC vs, EC-TX and Ibandronate vs. Observation in Patients With Node-positive Primary Breast Cancer (GAIN) [NCT00196872]Phase 33,000 participants (Anticipated)Interventional2004-07-31Completed
Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer [NCT00096304]Phase 136 participants (Anticipated)Interventional2004-06-08Terminated(stopped due to Low accrual)
Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy for Postmenopausal Estrogen Receptor-positive Breast Cancer: a Prospective Randomized Controlled Double-blind Phase IV Trial [NCT04137640]Phase 4152 participants (Anticipated)Interventional2021-07-19Not yet recruiting
An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer [NCT05253066]Phase 2/Phase 3130 participants (Anticipated)Interventional2022-02-25Not yet recruiting
A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive, HER2-negative Breast Cancer [NCT02742051]Phase 240 participants (Actual)Interventional2016-06-30Completed
A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC) [NCT00201396]Phase 3480 participants (Actual)Interventional2003-08-31Completed
Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response [NCT00425516]Phase 2264 participants (Actual)Interventional2007-01-31Completed
A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC) [NCT00218205]Phase 228 participants Interventional2002-07-31Recruiting
[NCT00189644]Phase 30 participants InterventionalActive, not recruiting
A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma [NCT00215514]Early Phase 125 participants (Actual)Interventional2000-09-30Completed
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration [NCT05296317]100 participants (Anticipated)Interventional2022-09-02Recruiting
A Phase Ⅱ Study to Evaluate Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) [NCT04676997]Phase 220 participants (Anticipated)Interventional2020-05-20Recruiting
A Randomized Controlled, Multi-center Clinical Study of Anbijian (Idarubicin Hydrochloride for Injection) vs. Epirubicin Lipiodol Emulsion Transhepatic Arterial Chemoembolization in the Treatment of Hepatocellular Carcinoma [NCT05053386]186 participants (Anticipated)Interventional2021-10-31Not yet recruiting
A Multi-center Randomized Phase II Study of Doxorubicin Liposome Versus Epirubicin Plus Cyclophosphamide Combined With Trastuzumab and Pertuzumab(HP), Followed by Taxon Plus HP as Neoadjuvant Therapy for HER2-positive Early Breast Cancer [NCT04172259]Phase 2156 participants (Anticipated)Interventional2019-01-10Active, not recruiting
MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood [NCT00002898]Phase 3400 participants (Anticipated)Interventional1995-01-31Completed
A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in Patients With HER2+ Early Breast Cancer [NCT03013504]Phase 3503 participants (Actual)Interventional2018-02-19Completed
A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients [NCT00431795]Phase 2100 participants (Actual)Interventional2003-06-30Terminated(stopped due to Due to poor accrual)
Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer [NCT00462696]30 participants (Anticipated)Interventional2006-02-28Completed
Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL [NCT00062296]Phase 25 participants (Actual)Interventional2003-03-31Completed
Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial [NCT05146635]110 participants (Anticipated)Interventional2021-12-01Recruiting
A Phase II Study of Neoadjuvant Chemotherapy With SEEOX Regimen Via Intra-arterial and Intravenous Administration Followed by Surgery for Borrmann Type 4 Gastric Cancer [NCT02949258]Phase 240 participants (Anticipated)Interventional2017-01-31Not yet recruiting
Adjuvant Cytotoxic Chemotherapy In Older Women [NCT00516425]Phase 31,000 participants (Anticipated)Interventional2007-01-31Recruiting
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer [NCT02909751]Phase 280 participants (Actual)Interventional2016-09-14Completed
Engaging the Immune System to Improve the Efficacy of Neoadjuvant Chemo-endocrine Therapy for Premenopausal Luminal B Breast Cancer Patients [NCT04659551]Phase 243 participants (Actual)Interventional2017-10-05Completed
Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer [NCT01220128]Phase 266 participants (Actual)Interventional2011-04-11Terminated(stopped due to Study termination due to negative Ph III of another study product from same technology platform.)
A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres [NCT00450203]Phase 2/Phase 31,103 participants (Anticipated)Interventional2007-10-31Recruiting
Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study [NCT05287308]500 participants (Anticipated)Interventional2022-03-31Not yet recruiting
Randomized Trial of High-dose Epirubicin and Cyclophosphamide x 3 Supported by Peripheral Blood Progenitor Cells Versus Anthracycline and Cyclophosphamide x 4 Followed by Cyclophosphamide, Methotrexate, and 5-fluorouracil x 3 as Adjuvant Treatment for Hig [NCT00002784]Phase 3344 participants (Actual)Interventional1996-06-30Completed
A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer [NCT00003012]Phase 31,000 participants (Anticipated)Interventional1996-10-31Completed
Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer [NCT00003606]Phase 3216 participants (Anticipated)Interventional1996-03-31Completed
Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors [NCT00003852]Phase 245 participants (Anticipated)Interventional1998-03-31Terminated(stopped due to lack of patient inclusion)
Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer [NCT01479036]Phase 3800 participants (Anticipated)Interventional2011-10-31Recruiting
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach [NCT00075465]Phase 20 participants Interventional2001-04-30Active, not recruiting
A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer [NCT00097383]Phase 1/Phase 20 participants InterventionalCompleted
Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer [NCT00242203]Phase 2120 participants (Actual)Interventional2002-10-31Completed
Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies [NCT00246103]Phase 182 participants (Actual)Interventional2004-03-31Completed
A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers [NCT00262210]Phase 250 participants Interventional1995-06-30Completed
Pyrotinib as Neoadjuvant Agent for Non-objective Response Patients of HER2-positive Early Breast Cancer Treated by Trastuzumab, Pertuzumab, and Chemotherapy (PYHOPE-BC-104): a Randomized, Controlled, Phase Ⅱ Trial [NCT04717531]Phase 260 participants (Anticipated)Interventional2021-06-03Recruiting
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer [NCT00123318]Phase 352 participants (Actual)Interventional2003-02-28Completed
A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer [NCT00429871]Phase 3272 participants (Actual)Interventional2002-05-31Completed
Neo-AEGIS (NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (Modified MAGIC or FLOT Regimen) vs. Neoadjuvant Chemoradiation (CROSS [NCT01726452]Phase 3377 participants (Actual)Interventional2013-01-24Completed
A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer [NCT00431080]Phase 3478 participants (Actual)Interventional2004-08-31Completed
Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy [NCT01740271]Phase 248 participants (Anticipated)Interventional2012-12-31Recruiting
A Prospective, Open-label,Multicentre,Real-word Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as Neoadjuvant Therapy for Women With HER2-positive and p95HER2-positive,PI3K Mutation,or PTEN Loss Breast Cancer [NCT03273595]Phase 2100 participants (Anticipated)Interventional2016-07-31Recruiting
Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer [NCT00140075]Phase 3606 participants (Actual)Interventional2000-11-30Completed
A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic St [NCT00464646]Phase 2105 participants (Actual)Interventional2007-05-31Completed
A Phase I Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of Chemotherapeutic Regiments in Surgical Patients With Infiltrating Ductal Carcinoma of Breast [NCT02897700]Phase 1300 participants (Anticipated)Interventional2013-01-31Recruiting
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma [NCT02987244]Phase 1/Phase 2100 participants (Anticipated)Interventional2016-03-31Recruiting
Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria: a Multi-center, Randomized, Parallel-controlled Study [NCT04738188]226 participants (Anticipated)Interventional2020-03-18Recruiting
Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer [NCT00527449]Phase 250 participants (Actual)Interventional2006-05-31Completed
Liposomal Doxorubicin-Investigational Chemotherapy-Tissue Doppler Imaging Evaluation (LITE) Randomized Pilot Study [NCT00531973]Phase 480 participants (Anticipated)Interventional2007-01-31Recruiting
A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00154739]Phase 286 participants (Anticipated)Interventional1998-10-31Completed
Prospective Evaluation of Topoisomerase II Alpha Gene Amplification and Protein Overexpression as Markers Predicting the Efficacy of Epirubicin in the Primary Treatment of Breast Cancer Patients [NCT00162812]Phase 2338 participants (Anticipated)Interventional2003-01-31Terminated(stopped due to Low accrual rate)
Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma [NCT00220103]Phase 280 participants (Anticipated)Interventional2002-11-30Completed
A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer [NCT00378313]Phase 276 participants Interventional2001-11-30Completed
Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma. [NCT02752815]Phase 4290 participants (Anticipated)Interventional2016-06-14Active, not recruiting
A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients [NCT00010140]Phase 30 participants Interventional1997-08-31Active, not recruiting
MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood [NCT00025441]Phase 20 participants Interventional1998-11-30Completed
Endovascular Brachytherapy Combined With Stent Placement and Transcatheter Arterial Chemoembolization (TACE) for Treatment of HCC With Main Portal Vein Tumor Thrombus Versus TACE Alone: a Prospective Randomized Controlled Multicentre Trial [NCT02971345]Phase 3253 participants (Anticipated)Interventional2017-01-31Recruiting
Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery [NCT00053911]Phase 30 participants Interventional2002-11-30Terminated
Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma [NCT00072319]Phase 20 participants Interventional2003-08-31Completed
A Prospective, Open, Randomized Controlled, Multi-center Phase III Clinical Trial Comparing High-dose Epirubicin and Standard-dose Epirubicin in R±CEOP in Newly Diagnosed Young Patients With Medium/High-risk Diffuse Large B-cell Lymphoma [NCT03151044]Phase 3408 participants (Anticipated)Interventional2016-07-31Recruiting
Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer [NCT00011921]Phase 3430 participants (Anticipated)Interventional1997-09-30Active, not recruiting
Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma [NCT00017186]Phase 269 participants (Actual)Interventional2001-07-31Completed
A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer [NCT00020748]Phase 10 participants Interventional2000-08-31Completed
Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Ne [NCT00630032]Phase 3762 participants (Actual)Interventional2007-09-30Completed
'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer [NCT00039546]Phase 30 participants Interventional2001-08-31Active, not recruiting
A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients [NCT00021047]Phase 1/Phase 20 participants Interventional2001-07-31Completed
A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus [NCT00041262]Phase 31,300 participants (Anticipated)Interventional2004-11-30Recruiting
An Open Label Prospective Randomised Study Comparing The Use Of Vincristine, Adriamycin And Cyclophosphamide (VAC) Versus Epirubicin, Cisplatin And Continuous 5-Flourouracil (ECF) In Patients With Unknown Primary Carcinoma (UPC) [NCT00022178]Phase 30 participants Interventional1998-12-31Active, not recruiting
A Phase III Randomized Neoadjuvant Study of Sequential Epirubicin/Cyclophosphamide and Paclitaxel + - Gemcitabine in Poor Risk Early Breast Cancer [NCT00070278]Phase 3800 participants (Anticipated)Interventional2005-01-31Active, not recruiting
Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer [NCT00038402]Phase 374 participants (Actual)Interventional2001-04-30Completed
A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer. [NCT00375999]Phase 234 participants (Actual)Interventional2006-09-30Completed
A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients [NCT00424606]Phase 3658 participants (Actual)Interventional2001-06-30Completed
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus [NCT00220129]Phase 216 participants (Actual)Interventional2002-11-30Completed
Combined Phase I/II Study of Epirubicin (Pharmorubicin®), Carboplatin (Paraplatin®) and Capecitabine (Xeloda®) (ECC) in the Treatment of Unresectable Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer With Pharmacogenetic Correlates [NCT00130936]Phase 1/Phase 250 participants (Anticipated)Interventional2005-10-31Terminated
A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer [NCT00047099]Phase 3446 participants (Anticipated)Interventional2001-08-31Completed
Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of [NCT00054587]Phase 33,010 participants (Actual)Interventional2001-06-30Completed
Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer [NCT00055679]Phase 31,512 participants (Actual)Interventional2002-08-31Completed
Evaluation of Response Rate to Pre-Operative Docetaxel + Herceptin Study Part A and Docetaxel Study Part B in Locally Advanced Breast Cancer Patients, Stratified by HER2-Status Trial - PHASE II [(Herceptin Docetaxel Neoadjuvant) HEDON] [NCT00398489]Phase 294 participants (Anticipated)Interventional2006-10-31Active, not recruiting
A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma [NCT00058487]Phase 212 participants (Anticipated)Interventional2001-12-31Completed
A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer [NCT00193024]Phase 290 participants Interventional2001-09-30Terminated
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemotherapy in Refractory Germ Cell Tumors [NCT00198172]Phase 237 participants Interventional2000-10-31Terminated(stopped due to Accrual Goal Met)
Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer [NCT00559845]Phase 256 participants (Actual)Interventional2008-02-29Completed
Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer [NCT02535221]Phase 3234 participants (Anticipated)Interventional2015-07-29Recruiting
Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy [NCT04771871]Phase 242 participants (Anticipated)Interventional2021-11-29Recruiting
Asia-wide, Multicenter Open-label, Phase II Non-randomised Study Involving Children With Down Syndrome Under 21 Year-old With Newly Diagnosed, Treatment naïve Acute Lymphoblastic Leukemia [NCT03286634]Phase 260 participants (Anticipated)Interventional2017-04-18Recruiting
Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer [NCT01276769]Phase 280 participants (Anticipated)Interventional2008-01-31Recruiting
A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer [NCT00176488]Phase 231 participants (Actual)Interventional2003-06-30Terminated(stopped due to Competing studies)
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" [NCT01641406]Phase 260 participants (Anticipated)Interventional2011-03-31Recruiting
A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer [NCT00288002]Phase 31,500 participants (Anticipated)Interventional2005-01-31Completed
An Adaptive Randomized Neoadjuvant Two Arm Trial in Triple-negative Breast Cancer Comparing a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (neoMono) [NCT04770272]Phase 2416 participants (Actual)Interventional2021-03-01Active, not recruiting
A Prospective, Randomized, Multicenter, Open-label Comparison of Pre-surgical Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy Given for Twelve Weeks With a Quality of Life Assessment of Trastuzumab, Pertu [NCT03272477]Phase 2257 participants (Actual)Interventional2017-10-05Active, not recruiting
Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2) [NCT00301925]Phase 34,400 participants (Anticipated)Interventional2005-12-16Active, not recruiting
A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients [NCT00309569]Phase 3429 participants (Actual)Interventional1991-10-31Completed
Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE] [NCT00311636]Phase 3280 participants (Anticipated)Interventional2003-09-30Completed
Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopa [NCT01503905]600 participants (Anticipated)Interventional2011-12-31Recruiting
[NCT01624025]Phase 222 participants (Actual)Interventional2012-06-30Completed
A Phase 1 Study With Dose Expansion of Dinaciclib (SCH 727965) in Combination With Epirubicin in Patients With Metastatic Triple Negative Breast Cancer [NCT01624441]Phase 140 participants (Actual)Interventional2012-08-21Completed
A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX (Epirubicin, Oxaliplatin, Capecitabine) Regimen as First-Line Treatment of Patients With CLDN18.2-Positive Advanced Adenocarcinom [NCT01630083]Phase 2252 participants (Actual)Interventional2012-07-19Completed
Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery [NCT01633203]61 participants (Actual)Observational2010-08-31Completed
A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer [NCT01642771]Phase 3636 participants (Anticipated)Interventional2012-06-30Active, not recruiting
Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer [NCT00003893]Phase 32,250 participants (Anticipated)Interventional1998-07-31Completed
Comparison the Safety and Efficacy of Epirubicin Plus Cyclophosphamide (EC)Versus Docetaxel Plus Cyclophosphamide (TC) in Lymph Node Negative, ER Positive, Her2 Negative Breast Cancer Patients as Adjuvant Chemotherapy [NCT02549677]Phase 4294 participants (Actual)Interventional2015-10-31Completed
Molecular Imaging for Response Assessment of Bevacizumab + Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer [NCT01690325]Phase 221 participants (Actual)Interventional2012-09-30Terminated(stopped due to Therapy of HER2+ patients according to protocol was no longer appropriate. Patient enrolment behind planned schedule and challenges of site performance)
Neo-/Adjuvant Phase III Trial to Compare Intense Dose-dense Chemotherapy to Tailored Dose-dense Chemotherapy in Patients With High-risk Early Breast Cancer (GAIN-2) [NCT01690702]Phase 32,886 participants (Actual)Interventional2012-09-30Completed
Molecular Markers Predictive Response to Dose Dense Chemotherapy With Epirubicin and Docetaxel in Sequences for Locally Advanced Breast Cancer. [NCT00496795]Phase 2100 participants (Anticipated)Interventional2007-09-30Active, not recruiting
A Phase II Study of Sorafenib With Chemotherapy, Radiation, and Surgery for High-Risk Soft Tissue Sarcomas [NCT02050919]Phase 220 participants (Actual)Interventional2013-12-03Completed
A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer [NCT01710592]Phase 235 participants (Actual)Interventional2007-05-31Completed
Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study. [NCT01830270]Phase 230 participants (Actual)Interventional2011-05-31Terminated
Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study [NCT03006614]Phase 3320 participants (Anticipated)Interventional2016-04-30Recruiting
A Multicenter, Single-arm Prospective Phase II Study of Chidamide in Combination With Chemotherapy for Neoadjuvant Treatment of HR-positive/HER2-negative Breast Cancer [NCT05400993]Phase 259 participants (Anticipated)Interventional2022-05-23Recruiting
Prospective Study To Validate The Predictive Value Of Mammostrat Score, DDR Score And TLE3 Gene When A Taxane-Based Chemo Agents Or Anthracycline-Based Chemo Agent Is Used In The Neo-Adjuvant Setting [NCT02067416]Phase 20 participants (Actual)Interventional2012-07-31Withdrawn(stopped due to Funding agent withdrew funding)
A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Re [NCT03725059]Phase 31,240 participants (Anticipated)Interventional2018-12-27Active, not recruiting
Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone. [NCT00002529]Phase 3452 participants (Actual)Interventional1993-05-31Completed
Treatment With the Combination of Epirubicin and Paclitaxel Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer. A Multicenter, Randomized Phase III Study [NCT01433614]Phase 3304 participants (Actual)Interventional2002-12-31Completed
A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors [NCT05887726]Phase 230 participants (Anticipated)Interventional2023-08-01Not yet recruiting
A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer [NCT03498716]Phase 32,203 participants (Actual)Interventional2018-08-02Completed
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N) [NCT05582499]Phase 1/Phase 2716 participants (Anticipated)Interventional2022-11-01Recruiting
A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer [NCT03609047]Phase 2366 participants (Anticipated)Interventional2019-06-14Active, not recruiting
A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer [NCT01924819]Phase 2/Phase 3574 participants (Actual)Interventional2009-09-30Active, not recruiting
Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer [NCT05983094]Phase 2181 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Double-Blind Randomized Trial of Tamoxifen Versus Placebo in Patients With Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy [NCT00002542]Phase 3672 participants (Actual)Interventional1993-07-20Completed
A Phase I/II Study of Docetaxel and Epirubicin as First-Line Therapy for Metastatic Breast Cancer [NCT00002866]Phase 150 participants (Anticipated)Interventional1996-08-12Completed
"Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: Stanford V Regimen For Low Risk Patients, EBVP Regimen For High Risk Patients" [NCT00003262]Phase 230 participants (Anticipated)Interventional1997-05-31Active, not recruiting
A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery [NCT00014222]Phase 32,104 participants (Actual)Interventional2000-12-04Completed
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma [NCT00052910]Phase 3546 participants (Actual)Interventional2002-12-31Completed
Phase III Randomized Trial of Immediate Adjuvant Chemotherapy or Delayed Salvage Chemotherapy in Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA [NCT02363400]Phase 3147 participants (Anticipated)Interventional2014-11-30Enrolling by invitation
Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients [NCT00129935]Phase 31,384 participants (Actual)Interventional2004-02-29Completed
A Randomized, Open-label, Single-center, Phase III Trial Comparing Docetaxel Plus Carboplatin (TCb) Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel (EC-T) Regimen as Adjuvant Chemotherapy in Patients With LN≥4 Estrogen Receptor Positive and [NCT05901428]Phase 31,736 participants (Anticipated)Interventional2023-06-01Recruiting
A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma [NCT04899570]Phase 220 participants (Anticipated)Interventional2021-04-01Recruiting
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients [NCT04836156]Phase 1/Phase 246 participants (Anticipated)Interventional2021-04-02Recruiting
A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc) [NCT02980965]Phase 3249 participants (Actual)Interventional2013-05-31Completed
A Prospective, Multicenter, Randomized Controlled Clinical Study of Blue Laser-5ALA-photodynamic Therapy (PDT) in the Prevention of Postoperative Tumor Recurrence in High-risk Non-muscle-invasive Bladder Cancer [NCT05547516]140 participants (Anticipated)Interventional2022-09-13Not yet recruiting
Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Azacitidine and Chidamide Combined With CHOP (AC-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma With T-follicular Helper Phenotype (PTCL-TFH) [NCT05678933]Phase 3200 participants (Anticipated)Interventional2023-01-01Enrolling by invitation
Efficacy and Safety of Pyrotinib in Combination With Neoadjuvant Chemotherapy in Stage II-III HR+/HER2-, HER4 High Expression Breast Cancer Patients: A Phase II, Single-center, Randomized, Double-Blinded, Placebo-Controlled Trial [NCT04872985]Phase 2140 participants (Anticipated)Interventional2021-04-20Recruiting
Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy [NCT01594177]Phase 265 participants (Actual)Interventional2012-05-31Completed
Neoadjuvant Docetaxel + Carboplatin Versus Epirubicin+Cyclophosphamide Followed by Docetaxel in Triple-Negative, Early-Stage Breast Cancer (NeoCART): Study Protocol for a Multicenter, Randomized Controlled, Open-Label, Phase 2 Trial [NCT03154749]Phase 293 participants (Actual)Interventional2016-09-01Completed
Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer [NCT00379015]Phase 238 participants (Actual)Interventional2006-01-31Completed
A RANDOMIZED, MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY [NCT00002870]Phase 3180 participants (Anticipated)Interventional1994-12-31Completed
A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer [NCT00004934]Phase 30 participants Interventional1999-08-31Completed
A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer [NCT00002953]Phase 3704 participants (Anticipated)Interventional1996-12-31Completed
A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer [NCT02132949]Phase 2401 participants (Actual)Interventional2014-07-14Completed
National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy [NCT00003577]Phase 32,000 participants (Anticipated)Interventional1996-03-31Completed
A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer [NCT00004237]Phase 20 participants Interventional1998-10-31Completed
Taxotere-Cisplatin-5FU (TCF) Versus Taxotere-Cisplatin (TC) Versus Epirubicin-Cisplatin-5FU (ECF) as Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial [NCT00004873]Phase 20 participants Interventional1999-08-31Completed
Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study [NCT00005581]Phase 31,000 participants (Anticipated)Interventional2000-06-30Active, not recruiting
Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer [NCT01855828]Phase 250 participants (Actual)Interventional2013-09-30Completed
A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER [NCT00002615]Phase 3500 participants (Anticipated)Interventional1994-06-30Completed
A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carb [NCT05883852]Phase 31,406 participants (Anticipated)Interventional2023-06-07Recruiting
A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma [NCT00005583]Phase 3400 participants (Anticipated)Interventional2000-01-31Completed
Clinical Study Comparing the Efficacy and Safety of Traditional Herbal Medicine for Cancer Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy in Patients With Stage II-III Breast Cancer. [NCT05483439]Phase 2100 participants (Anticipated)Interventional2021-10-20Recruiting
Randomized Open-label, Multicentric, Phase II Clinical Trial to Evaluate the Efficacy of a Neoadjuvant Chemotherapy Scheme Customized by Levels of BRCA1 in Women With Primary HER2 Negative Breast Cancer (The BERNAQ Clinical Trial) [NCT02365805]Phase 230 participants (Actual)Interventional2014-04-30Completed
A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE [NCT05900206]Phase 2370 participants (Anticipated)Interventional2023-10-09Recruiting
A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Respons [NCT00773695]Phase 2150 participants (Actual)Interventional2008-11-07Completed
Epirubicin for the Treatment of Sepsis & Septic Shock [NCT05033808]Phase 245 participants (Anticipated)Interventional2022-10-19Recruiting
A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer [NCT05914753]200 participants (Anticipated)Interventional2023-07-01Not yet recruiting
Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study [NCT05128617]20 participants (Actual)Observational2021-11-04Completed
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer [NCT06121570]Phase 124 participants (Anticipated)Interventional2023-11-01Recruiting
Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer [NCT03025477]Phase 284 participants (Anticipated)Interventional2016-10-31Recruiting
Randomized Phase II Open-Label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-line Treatment in Subjects With Metastatic Esophago-Gastric Adenocarcinoma [NCT00215644]Phase 272 participants (Actual)Interventional2005-08-31Completed
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial [NCT05165225]Phase 248 participants (Anticipated)Interventional2021-07-13Active, not recruiting
A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Ca [NCT00513292]Phase 3280 participants (Actual)Interventional2007-07-31Completed
Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients [NCT02338518]Phase 3297 participants (Actual)Interventional2015-01-04Active, not recruiting
A Multicentre, Randomised Phase II to Compare Epirubicin (E) & Cyclophosphamide (C) Treatment Plus Docetaxel (D) & Trastuzumab vs. E & C Treatment Plus D & Lapatinib in Women With Primary Resectable or Locally Advanced HER2+ Breast Cancer [NCT00841828]Phase 2102 participants (Actual)Interventional2009-02-28Completed
A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2 [NCT01593020]Phase 254 participants (Actual)Interventional2012-08-03Completed
Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer:A Prospective, Randomized, Phase III Trial [NCT02455141]Phase 3970 participants (Anticipated)Interventional2015-07-31Recruiting
Differential Gene Regulation During Neoadjuvant Therapy Trial of Epirubicin/Cyclophosphamide (EC) vs Docetaxel/Capecitabine (DX) Regimens in Patients With Large ER-positive and ER-negative Breast Cancers: A Randomized Phase II Trial. [NCT01869192]Phase 272 participants (Actual)Interventional2003-03-05Completed
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line T [NCT05121350]Phase 3256 participants (Anticipated)Interventional2022-03-31Recruiting
Adjuvant Six Cycles of Docetaxel and Cyclophosphamide or Three Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by Three Cycles of Docetaxel Versus Four Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast [NCT04127019]Phase 32,079 participants (Actual)Interventional2010-06-01Completed
TCH (Docetaxel/Carboplatin/Trastuzumab) Versus EC -TH(Epirubicin/Cyclophosphamide Followed by Docetaxe/Trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer [NCT03140553]Phase 2140 participants (Actual)Interventional2016-09-01Completed
Antitumor Immune Responses in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: a Phase II Study With Trastuzumab and Concomitant Weekly Paclitaxel in Patients With HER2+ Tumors or Epirubicin + Taxotere in HER2- Tumors. [NCT02307227]Phase 246 participants (Actual)Interventional2006-04-30Completed
Pathological Complete Response Rate in Locally Advanced Breast Cancer With Neoadjuvant Fluorourcil/Epirubicin/Cyclophosphamide, Epirubicin/Cyclophosphamide Followed by Docetaxel, or Docetaxel/Cyclophosphamide as Neoadjuvant Chemotherapy [NCT03349177]Phase 2/Phase 3200 participants (Anticipated)Interventional2017-11-27Not yet recruiting
Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial [NCT05131893]300 participants (Anticipated)Observational [Patient Registry]2022-03-31Not yet recruiting
An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer(NeoSACT) [NCT04877821]Phase 231 participants (Anticipated)Interventional2021-09-15Recruiting
Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel (EC-T) Verses Paclitaxel Combined With Carboplatin (PCb) in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer [NCT04193059]Phase 31,560 participants (Anticipated)Interventional2018-08-01Recruiting
The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma [NCT03022123]270 participants (Anticipated)Interventional2016-11-30Recruiting
A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer [NCT05978648]Phase 2116 participants (Anticipated)Interventional2023-09-20Recruiting
PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer [NCT02299999]Phase 21,460 participants (Actual)Interventional2014-04-07Active, not recruiting
A Phase II One-arm Open-label Neoadjuvant Study of Pembrolizumab in Combination With Nab-paclitaxel Followed by Pembrolizumab in Combination With Epirubicin and Cyclophosphamide in Patients With Triple Negative Breast Cancer [NCT03289819]Phase 253 participants (Actual)Interventional2018-03-23Completed
A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma [NCT02358863]13 participants (Actual)Interventional2015-02-28Terminated(stopped due to Issues with recruitment.)
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as Perioperative Treatment in Participants With HER2 Negative Breast Cancer [NCT04498793]Phase 255 participants (Anticipated)Interventional2020-09-30Not yet recruiting
Fluorouracil, Epirubicin and Cyclophosphamide Versus Concurrent Epirubicin and Paclitaxel in Node Positive Early Breast Cancer Patients: a Randomized, Phase III Trial of Gruppo Oncologico Nord-Ovest - Mammella Intergruppo Group [NCT02450058]Phase 31,055 participants (Actual)Interventional1996-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00014222 (2) [back to overview]Overall Survival
NCT00014222 (2) [back to overview]Disease Free Survival
NCT00052910 (2) [back to overview]Overall Survival
NCT00052910 (2) [back to overview]Disease Free Survival
NCT00087178 (8) [back to overview]Adverse Events
NCT00087178 (8) [back to overview]Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation
NCT00087178 (8) [back to overview]Disease Free Survival
NCT00087178 (8) [back to overview]Distant Recurrence-free Interval
NCT00087178 (8) [back to overview]Post Chemotherapy Amenorrhea
NCT00087178 (8) [back to overview]Recurrence-free Interval
NCT00087178 (8) [back to overview]Survival
NCT00087178 (8) [back to overview]Quality of Life-Functional Assessment of Cancer Therapy
NCT00129935 (4) [back to overview]The Number of Participants Who Experienced Adverse Events (AE)
NCT00129935 (4) [back to overview]Quality of Life Questionnaire: Time to Taking Off the Wig
NCT00129935 (4) [back to overview]Number of Participants With Overall Survival (OS) Event
NCT00129935 (4) [back to overview]Number of Participants With Disease-free Survival (DFS) Event
NCT00193050 (3) [back to overview]Time to Treatment Failure (TTF)
NCT00193050 (3) [back to overview]Pathologic Complete Response (pCR)
NCT00193050 (3) [back to overview]Overall Survival (OS)
NCT00193206 (4) [back to overview]Time to Disease Progression
NCT00193206 (4) [back to overview]Rates of Breast Preservation
NCT00193206 (4) [back to overview]Pathologic Complete Response
NCT00193206 (4) [back to overview]Clinical Response Rates
NCT00215644 (5) [back to overview]Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score
NCT00215644 (5) [back to overview]Progression-Free Survival
NCT00215644 (5) [back to overview]Percentage of Participants With Objective Response Assessed by Independent Review Committee
NCT00215644 (5) [back to overview]Overall Survival (OS)
NCT00215644 (5) [back to overview]Duration of Objective Response Assessed by Independent Review Committee
NCT00270894 (7) [back to overview]Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
NCT00270894 (7) [back to overview]Pathologic Response
NCT00270894 (7) [back to overview]Left Ventricular Ejection Fraction (LVEF)
NCT00270894 (7) [back to overview]Overall Survival (OS)
NCT00270894 (7) [back to overview]Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
NCT00270894 (7) [back to overview]Progression-free Survival (PFS)
NCT00270894 (7) [back to overview]Clinical Response Prior to Surgery
NCT00322374 (16) [back to overview]Epirubicin CLT
NCT00322374 (16) [back to overview]Terminal Half-life (T-Half) of Single-dose Ixabepilone
NCT00322374 (16) [back to overview]Epirubicin Vss
NCT00322374 (16) [back to overview]Number Of Participants With Tumor Response by Duration of Response Category
NCT00322374 (16) [back to overview]Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
NCT00322374 (16) [back to overview]Epirubicin T-Half
NCT00322374 (16) [back to overview]Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation
NCT00322374 (16) [back to overview]Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone
NCT00322374 (16) [back to overview]Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease
NCT00322374 (16) [back to overview]Epirubicin Cmax
NCT00322374 (16) [back to overview]Number of Participants With a Dose Limiting Toxicity (DLT)
NCT00322374 (16) [back to overview]Epirubicin AUC(INF)
NCT00322374 (16) [back to overview]Duration of Tumor Response
NCT00322374 (16) [back to overview]Clearance (CLT) of Single-dose Ixabepilone
NCT00322374 (16) [back to overview]Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone
NCT00322374 (16) [back to overview]Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone
NCT00375999 (1) [back to overview]Overall Survival
NCT00381706 (5) [back to overview]Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
NCT00381706 (5) [back to overview]Time to Treatment Failure in Patients With Adenocarcinoma
NCT00381706 (5) [back to overview]Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
NCT00381706 (5) [back to overview]Progression-free Survival in Patients With Adenocarcinoma
NCT00381706 (5) [back to overview]Overall Survival in Patients With Adenocarcinoma
NCT00429299 (8) [back to overview]Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography
NCT00429299 (8) [back to overview]Number of Variations/Somatic Mutation in PI3KCA at Baseline
NCT00429299 (8) [back to overview]Number of Participants With Treatment Failure
NCT00429299 (8) [back to overview]Time to Treatment Failure From the Start of Primary Therapy
NCT00429299 (8) [back to overview]Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS
NCT00429299 (8) [back to overview]Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment
NCT00429299 (8) [back to overview]Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants
NCT00429299 (8) [back to overview]Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes
NCT00432172 (1) [back to overview]Clinical Response Rate
NCT00454636 (6) [back to overview]Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
NCT00454636 (6) [back to overview]Overall Survival (OS)
NCT00454636 (6) [back to overview]Overall Response Rate (ORR)
NCT00454636 (6) [back to overview]Duration of Response
NCT00454636 (6) [back to overview]Time to Response
NCT00454636 (6) [back to overview]Progression-Free Survival (PFS)
NCT00464646 (8) [back to overview]Recurrence-free Survival
NCT00464646 (8) [back to overview]Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)
NCT00464646 (8) [back to overview]Overall Survival
NCT00464646 (8) [back to overview]Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)
NCT00464646 (8) [back to overview]Clinical Complete Response (cCR)
NCT00464646 (8) [back to overview]Number of Participants With Cardiac Events
NCT00464646 (8) [back to overview]Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)
NCT00464646 (8) [back to overview]Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen.
NCT00499603 (3) [back to overview]Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours
NCT00499603 (3) [back to overview]Participant Responses Per Treatment Arm at 12 Weeks
NCT00499603 (3) [back to overview]Participant Responses Per Treatment Arm at 24 Weeks
NCT00513292 (9) [back to overview]Asymptomatic Decreases From Baseline in LVEF at Week 24
NCT00513292 (9) [back to overview]Breast Conservation
NCT00513292 (9) [back to overview]Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week
NCT00513292 (9) [back to overview]Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy
NCT00513292 (9) [back to overview]Disease-free Survival (DFS)
NCT00513292 (9) [back to overview]LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week
NCT00513292 (9) [back to overview]Overall Survival (OS)
NCT00513292 (9) [back to overview]pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy
NCT00513292 (9) [back to overview]Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
NCT00559845 (5) [back to overview]Percentage of Participants With Breast-Conserving Surgery
NCT00559845 (5) [back to overview]Percentage of Participants With Disease-Free Interval
NCT00559845 (5) [back to overview]Objective Response Rate
NCT00559845 (5) [back to overview]Percentage of Participants Experiencing Any Adverse Event
NCT00559845 (5) [back to overview]Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
NCT00601705 (6) [back to overview]Overall Survival
NCT00601705 (6) [back to overview]Postoperative Adjuvant Chemoradiotherapy Feasibility
NCT00601705 (6) [back to overview]Locoregional Control and Distant Metastatic Control
NCT00601705 (6) [back to overview]Pathological Response Rate
NCT00601705 (6) [back to overview]Feasibility of Induction Chemoradiotherapy as Measured by Resectability Rate
NCT00601705 (6) [back to overview]Clinical Response Rate
NCT00630032 (6) [back to overview]Number of Disease-free Survival Events for Triple-negative Subgroup
NCT00630032 (6) [back to overview]Number of Distant Metastasis-free Survival Events for the Whole Population
NCT00630032 (6) [back to overview]Number of Event-free Survival
NCT00630032 (6) [back to overview]Overall Survival
NCT00630032 (6) [back to overview]Percentage of Participants With Disease-free Survival (DFS)
NCT00630032 (6) [back to overview]Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup
NCT00667420 (5) [back to overview]Overall Survival
NCT00667420 (5) [back to overview]Pathologic Complete Response Rate
NCT00667420 (5) [back to overview]Progression-Free Survival
NCT00667420 (5) [back to overview]R0 Resection Rate
NCT00667420 (5) [back to overview]Safety and Tolerability
NCT00737438 (1) [back to overview]Overall Response Will be Characterized by the Patient's FDG-PET Scan
NCT00756470 (2) [back to overview]Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
NCT00756470 (2) [back to overview]Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
NCT00841828 (2) [back to overview]Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).
NCT00841828 (2) [back to overview]Overall Clinical Response Rate (ORR)
NCT00950300 (22) [back to overview]Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline
NCT00950300 (22) [back to overview]Percentage of Participants Who Experienced a Protocol-Defined Event
NCT00950300 (22) [back to overview]Percentage of Participants Who Died
NCT00950300 (22) [back to overview]Overall Survival (OS)
NCT00950300 (22) [back to overview]Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery
NCT00950300 (22) [back to overview]Observed Ctrough of Trastuzumab After Surgery
NCT00950300 (22) [back to overview]Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery
NCT00950300 (22) [back to overview]Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery
NCT00950300 (22) [back to overview]Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery
NCT00950300 (22) [back to overview]Event-Free Survival (EFS)
NCT00950300 (22) [back to overview]Cmax of Trastuzumab After Surgery
NCT00950300 (22) [back to overview]AUC21d of Trastuzumab After Surgery
NCT00950300 (22) [back to overview]Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery
NCT00950300 (22) [back to overview]Predicted Ctrough of Trastuzumab Prior to Surgery
NCT00950300 (22) [back to overview]Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab
NCT00950300 (22) [back to overview]Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)
NCT00950300 (22) [back to overview]Tmax of Trastuzumab After Surgery
NCT00950300 (22) [back to overview]Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline
NCT00950300 (22) [back to overview]Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery
NCT00950300 (22) [back to overview]Predicted Ctrough of Trastuzumab After Surgery
NCT00950300 (22) [back to overview]Percentage of Participants With Total Pathological Complete Response (tpCR)
NCT00950300 (22) [back to overview]Percentage of Participants With Pathological Complete Response (pCR)
NCT00954512 (2) [back to overview]Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
NCT00954512 (2) [back to overview]Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
NCT01036087 (2) [back to overview]Number of Participants With Treatment-related Adverse Events (AEs)
NCT01036087 (2) [back to overview]Number of Participants That Achieved Pathologic Complete Response (CR)
NCT01061359 (1) [back to overview]Percentage of Participants With Disease Free Survival (DFS)
NCT01220128 (28) [back to overview]Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported
NCT01220128 (28) [back to overview]Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported
NCT01220128 (28) [back to overview]Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported
NCT01220128 (28) [back to overview]Number of Patients With Adverse Events (AEs)
NCT01220128 (28) [back to overview]Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response
NCT01220128 (28) [back to overview]Number of Subjects With Serious Adverse Events SAE(s)
NCT01220128 (28) [back to overview]Number of Subjects With Severe Toxicities
NCT01220128 (28) [back to overview]Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported
NCT01220128 (28) [back to overview]Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Anemia, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Breast Cancer Pathological Response
NCT01220128 (28) [back to overview]Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade
NCT01220128 (28) [back to overview]Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade
NCT01358877 (30) [back to overview]Percentage of Participants With Secondary Cardiac Event
NCT01358877 (30) [back to overview]Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Percentage of Participants Who Died
NCT01358877 (30) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Trough Serum Concentration (Cmin) of Pertuzumab
NCT01358877 (30) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
NCT01358877 (30) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
NCT01358877 (30) [back to overview]Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
NCT01358877 (30) [back to overview]Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
NCT01358877 (30) [back to overview]Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
NCT01358877 (30) [back to overview]Percentage of Participants With Primary Cardiac Event
NCT01358877 (30) [back to overview]Peak Serum Concentration (Cmax) of Pertuzumab
NCT01358877 (30) [back to overview]Cmin of Trastuzumab
NCT01358877 (30) [back to overview]Cmax of Trastuzumab
NCT01358877 (30) [back to overview]Change From Baseline in LVEF to Worst Post-Baseline Value
NCT01358877 (30) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
NCT01358877 (30) [back to overview]Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
NCT01358877 (30) [back to overview]Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
NCT01358877 (30) [back to overview]Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
NCT01358877 (30) [back to overview]Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
NCT01358877 (30) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
NCT01358877 (30) [back to overview]Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
NCT01358877 (30) [back to overview]Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
NCT01593020 (3) [back to overview]Overall Survival (OS)
NCT01593020 (3) [back to overview]5 Year Event Free Survival (EFS)
NCT01593020 (3) [back to overview]Pathologic Complete Response (pCR)
NCT01779050 (2) [back to overview]Death Rate
NCT01779050 (2) [back to overview]Number of Participants With Disease Recurrence
NCT01855828 (4) [back to overview]Residual Cancer Burden Score
NCT01855828 (4) [back to overview]Count of Patients With Clinical Response
NCT01855828 (4) [back to overview]Proportion of Participants With a Pathologic Complete Response Rate
NCT01855828 (4) [back to overview]Cardiac Safety
NCT01869192 (2) [back to overview]Pathological Response
NCT01869192 (2) [back to overview]Overall Response Rate
NCT01966471 (12) [back to overview]IDFS Plus Second Primary Non-Breast Cancer
NCT01966471 (12) [back to overview]Percentage of Participants With Adverse Events
NCT01966471 (12) [back to overview]Overall Survival (OS)
NCT01966471 (12) [back to overview]Invasive Disease-Free Survival (IDFS) in the Overall Population
NCT01966471 (12) [back to overview]Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
NCT01966471 (12) [back to overview]Disease-Free Survival (DFS)
NCT01966471 (12) [back to overview]European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
NCT01966471 (12) [back to overview]Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
NCT01966471 (12) [back to overview]Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
NCT01966471 (12) [back to overview]European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
NCT01966471 (12) [back to overview]EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
NCT01966471 (12) [back to overview]Distant Recurrence-Free Interval (DRFI)
NCT02050919 (7) [back to overview]Pathologic Response Rate, Defined as the Percentage of Participants With Greater Than or Equal to 95% Necrosis.
NCT02050919 (7) [back to overview]Overall Survival at 2 Years
NCT02050919 (7) [back to overview]Number of Participants With Wound Complications
NCT02050919 (7) [back to overview]Number of Grade 3-4 Adverse Events
NCT02050919 (7) [back to overview]Overall Disease-free Survival (Stage IIB-III Patients)
NCT02050919 (7) [back to overview]Distant Disease-free Survival (Stage IIB-III Patients)
NCT02050919 (7) [back to overview]Number of Participants With Local Recurrence
NCT02132949 (15) [back to overview]Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery
NCT02132949 (15) [back to overview]Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period
NCT02132949 (15) [back to overview]Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period
NCT02132949 (15) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years
NCT02132949 (15) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1
NCT02132949 (15) [back to overview]Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1
NCT02132949 (15) [back to overview]Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period
NCT02132949 (15) [back to overview]Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period
NCT02132949 (15) [back to overview]Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period
NCT02132949 (15) [back to overview]Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period
NCT02132949 (15) [back to overview]Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period
NCT02132949 (15) [back to overview]Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period
NCT02132949 (15) [back to overview]Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline
NCT02132949 (15) [back to overview]Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period
NCT02132949 (15) [back to overview]Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period
NCT02315196 (1) [back to overview]Rate of Pathologic Complete Response (pCR) Based on Response Evaluation Criteria in Solid Tumors Criteria
NCT02358863 (1) [back to overview]The Number of Patients With Tumor Size Reduction (Objective Response Rate)
NCT03113955 (8) [back to overview]Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
NCT03113955 (8) [back to overview]Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
NCT03113955 (8) [back to overview]Number of Participants With Objective Tumor Response at 3 Months
NCT03113955 (8) [back to overview]Number of Participants With Objective Tumor Response at 30-day
NCT03113955 (8) [back to overview]Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
NCT03113955 (8) [back to overview]Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
NCT03113955 (8) [back to overview]Kaplan-Meier Analyses the Percent of Participants for Overall Survival
NCT03113955 (8) [back to overview]Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
NCT03556358 (2) [back to overview]Objective Response Rate (ORR)
NCT03556358 (2) [back to overview]Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)

Overall Survival

Overall survival was defined as the time from randomization to the time of death from any cause, with censoring at longest follow-up. (NCT00014222)
Timeframe: 13 years

,,
InterventionParticipants (Count of Participants)
DeathAlive
Arm 1: CEF123578
Arm 2: EC/T107594
Arm 3: AC/T146556

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Disease Free Survival

Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence. (NCT00014222)
Timeframe: 13 years

,,
InterventionParticipants (Count of Participants)
Disease RecurrenceNo recurrence
Arm 1: CEF141560
Arm 2: EC/T135566
Arm 3: AC/T191511

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Overall Survival

Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT00052910)
Timeframe: From study enrollment until death from any cause; up to 3 years

Interventionyears (Median)
Arm I (5-FU/LV)3.6
Arm II (ECF)3.5

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Disease Free Survival

Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier. (NCT00052910)
Timeframe: From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years

Interventionyears (Median)
Arm I (5-FU/LV)2.7
Arm II (ECF)2.3

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Adverse Events

Percentage of patients with at least one grade 2 or higher adverse event reported (NCT00087178)
Timeframe: 9 years

Interventionpercentage of participants (Number)
Arm 1: Adriamycin + Cyclophosphamide28.5
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide45.0

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Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation

Change in LVEF from randomization to 12 months (NCT00087178)
Timeframe: 12 months

InterventionChange in percent ejection fraction (Mean)
Arm 1: Adriamycin + Cyclophosphamide-2.61
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide-2.65

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Disease Free Survival

Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer (NCT00087178)
Timeframe: 9 years

Interventionpercentage of participants (Number)
Arm 1: Adriamycin + Cyclophosphamide80.1
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide79.4

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Distant Recurrence-free Interval

Percentage of patients with distant recurrence (NCT00087178)
Timeframe: 9 years

Interventionpercentage of participants (Number)
Arm 1: Adriamycin + Cyclophosphamide8.3
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide7.2

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Post Chemotherapy Amenorrhea

Percent with post chemotherapy amenorrhea (NCT00087178)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Arm 1: Adriamycin + Cyclophosphamide59.1
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide67.4

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Recurrence-free Interval

Percentage of patients with local-regional recurrence or distant recurrence (NCT00087178)
Timeframe: 9 years

Interventionpercentage of participants (Number)
Arm 1: Adriamycin + Cyclophosphamide10.8
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide10.4

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Survival

Percentage of patients alive (NCT00087178)
Timeframe: 9 years

Interventionpercentage of participants alive (Number)
Arm 1: Adriamycin + Cyclophosphamide89.8
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide89.9

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Quality of Life-Functional Assessment of Cancer Therapy

Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL. (NCT00087178)
Timeframe: 12 months

,
Interventionscore on a scale (Least Squares Mean)
Score day 1 cycle 4Score 6 monthsScore 12 months
Arm 1: Adriamycin + Cyclophosphamide61.769.271.7
Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide60.366.971.1

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The Number of Participants Who Experienced Adverse Events (AE)

Safety was assessed by standard clinical and laboratory tests, and were evaluated using NCI-CTC criteria v2.0 (NCT00129935)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Arm A: EC-T665
Arm B: ET-X699

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Quality of Life Questionnaire: Time to Taking Off the Wig

"Time to taking off the wig was assessed by a specific Hair Toxicity Questionnaire were patients answered when they stop to use the wig.~The questionnaire was evaluated up to two years after the end of chemotherapy." (NCT00129935)
Timeframe: Up to 30 months

InterventionMonths (Median)
Arm A: EC-T8.35
Arm B: ET-X6.03

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Number of Participants With Overall Survival (OS) Event

A participant was considered to have had a OS event if patient died from any cause. (NCT00129935)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Arm A: EC-T70
Arm B: ET-X83

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Number of Participants With Disease-free Survival (DFS) Event

A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason. (NCT00129935)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Arm A: EC-T127
Arm B: ET-X170

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Time to Treatment Failure (TTF)

"Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates:~disease progression date (RECIST or clinical)~death date~treatment discontinuation" (NCT00193050)
Timeframe: 69 months

Interventionmonths (Median)
Intervention13

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Pathologic Complete Response (pCR)

For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported. (NCT00193050)
Timeframe: 18 Months

Interventionpercentage of participants (Number)
Intervention18

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Overall Survival (OS)

Number of participants that are alive at 48th months (NCT00193050)
Timeframe: 48 months

InterventionParticipants (Count of Participants)
Intervention72

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Time to Disease Progression

Time to progression is the length of time from the start of treatment until the disease progressed. Progressive disease is defined as an increase of >25% in the total calculated product of the tumor's measurements or development of a new lesion. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST) (NCT00193206)
Timeframe: 36 months

Interventionmonths (Median)
Intervention13.7

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Rates of Breast Preservation

Number of patients who underwent breast conservation after neo adjuvant chemotherapy (NCT00193206)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Intervention26

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Pathologic Complete Response

For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported. (NCT00193206)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Intervention23

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Clinical Response Rates

Clinical response rate is defined as percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment). Clinical tumor response was defined as complete if there was no clinical evidence of palpable tumor in either the breast or axilla at the time of surgery. Reduction of total tumor size >50 % at the time surgery was considered a clinical partial response. Evaluations are based on Response Evaluation Criteria in Solid Tumors (RECIST) (NCT00193206)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Intervention109

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Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score

EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported. (NCT00215644)
Timeframe: Baseline (Day 1), Post Baseline (Up to 3 Years)

,
Interventionunits on a scale (Mean)
BaselinePost-Baseline
ECX Only67.9-10.0
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab53.30.0

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Progression-Free Survival

PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis. (NCT00215644)
Timeframe: Baseline up to PD or death due to any cause (up to approximately 3 years)

Interventionmonths (Median)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab4.8
ECX Only7.1

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Percentage of Participants With Objective Response Assessed by Independent Review Committee

Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. (NCT00215644)
Timeframe: Baseline up to PD or death due to any cause (up to approximately 3 years)

Interventionpercentage of participants (Number)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab31
ECX Only58

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Overall Survival (OS)

OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis. (NCT00215644)
Timeframe: Baseline until death due to any cause (up to approximately 3 years)

Interventionmonths (Median)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab9.4
ECX Only12.2

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Duration of Objective Response Assessed by Independent Review Committee

Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis. (NCT00215644)
Timeframe: From first documented objective response to PD or death due to any cause (up to approximately 3 years)

Interventionmonths (Median)
Epirubicin, Cisplatin, Capecitabine (ECX)+MatuzumabNA
ECX OnlyNA

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Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities

Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE. (NCT00270894)
Timeframe: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.

InterventionEvents (Number)
CTCAE grade 3 hematologic eventsCTCAE grade 3 non-hematologic eventsCTCAE grade 4 hematologic eventsCTCAE grade 4 non-hematologic events
Neoadjuvant Therapy21100

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Pathologic Response

Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters. (NCT00270894)
Timeframe: At completion of neoadjuvant treatment period, up to 24 weeks.

InterventionParticipants (Number)
Pathologic complete response (pCR)Pathologic partial response (pPR)Stable disease (SD)
Neoadjuvant Therapy1693

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Left Ventricular Ejection Fraction (LVEF)

LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up. (NCT00270894)
Timeframe: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36

InterventionLVEF percent (Mean)
ScreeningAfter Epirubicin/CyclophosphamidePre-SurgeryFollow-up Month 6Follow-up Month 12Follow-up Month 24Follow-up Month 36
Neoadjuvant Therapy63.5561.9456.8857.6858.1559.3855.00

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Overall Survival (OS)

Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. (NCT00270894)
Timeframe: Measured from day 1 of treatment until time of death, assessed up to 48 months.

InterventionMonths (Median)
Neoadjuvant TherapyNA

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Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule

Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose. (NCT00270894)
Timeframe: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)

Interventionpercentage of participants (Number)
Neoadjuvant Therapy60

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Progression-free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. (NCT00270894)
Timeframe: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.

InterventionMonths (Median)
Neoadjuvant TherapyNA

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Clinical Response Prior to Surgery

Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters. (NCT00270894)
Timeframe: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.

InterventionParticipants (Number)
Clinical complete responseClinical partial responseClinical stable disease
Neoadjuvant Therapy2052

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Epirubicin CLT

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.

InterventionL/h (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m281.33
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m253.85
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m258.00

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Terminal Half-life (T-Half) of Single-dose Ixabepilone

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

Interventionhours (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m251.82
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m234.07
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m244.15

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Epirubicin Vss

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.

Interventionliters (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2912.83
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2750.24
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2522.45

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Number Of Participants With Tumor Response by Duration of Response Category

Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions. (NCT00322374)
Timeframe: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.

,
Interventionparticipants (Number)
Response Duration < 4 MonthsResponse Duration ≥4 MonthsResponse Duration ≥6 Months
All Participants With Measurable Disease and Tumor Response51311
All Response-evaluable Participants186

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Epirubicin T-Half

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.

Interventionhours (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m213.61
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m219.41
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m215.55

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Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation

AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (NCT00322374)
Timeframe: Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.

,,
Interventionparticipants (Number)
Deaths (total)Deaths within 30 days of last doseAEsSAEsGrade 3/4 AEsAEs leading to discontinuation of study treatment
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2006264
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2003082812
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2006161

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Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone

Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

Interventionng/ml (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2169.00
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2217.86
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2251.83

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Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease

Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria. (NCT00322374)
Timeframe: From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2

,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
All Participants With Measurable Disease018113
All Response-evaluable Participants09103

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Epirubicin Cmax

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.

Interventionng/ml (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m23306.53
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m24139.00
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m24533.08

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Number of Participants With a Dose Limiting Toxicity (DLT)

DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks (NCT00322374)
Timeframe: From Baseline to the end of Cycle 1 (Day 21)

,,
InterventionParticipants (Number)
Participants with DLT:Grade 4 (severe) neutropeniaTotal Participants with DLTParticipants without DLT
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2115
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2115
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2224

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Epirubicin AUC(INF)

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.

Interventionng·h/mL (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m22489.37
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m23132.67
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m22595.44

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Duration of Tumor Response

Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions. (NCT00322374)
Timeframe: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.

Interventionmonths (Median)
All Participants With Measurable Disease and Tumor Response6.45
All Response-evaluable Participants6.4

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Clearance (CLT) of Single-dose Ixabepilone

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

InterventionL/h (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m226.03
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m224.62
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m226.68

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Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

Interventionng·h/mL (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m21760.42
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m22072.43
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m22100.56

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Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone

PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data. (NCT00322374)
Timeframe: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

Interventionliters (Mean)
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m21331.65
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2803.21
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m21001.70

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Overall Survival

(NCT00375999)
Timeframe: One year

Interventionmonth (Median)
Treatment Group13.4

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Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionpercentage of participants (Number)
Arm A: Adenocarcinoma (ECF + Cetuximab)61
Arm B: Adenocarcinoma (IC + Cetuximab)45
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)54

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Time to Treatment Failure in Patients With Adenocarcinoma

Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionmonths (Median)
Arm A: Adenocarcinoma (ECF + Cetuximab)5.6
Arm B: Adenocarcinoma (IC + Cetuximab)4.3
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)6.7

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Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionpercentage of participants (Number)
Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)67
Arm B: Squamous Cell Carcinoma (IC + Cetuximab)13
Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)60

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Progression-free Survival in Patients With Adenocarcinoma

Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionmonths (Median)
Arm A: Adenocarcinoma (ECF + Cetuximab)7.1
Arm B: Adenocarcinoma (IC + Cetuximab)4.9
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)6.8

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Overall Survival in Patients With Adenocarcinoma

Overall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00381706)
Timeframe: Up to 2 years post-treatment

Interventionmonths (Median)
Arm A: Adenocarcinoma (ECF + Cetuximab)11.6
Arm B: Adenocarcinoma (IC + Cetuximab)8.6
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)11.8

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Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography

The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value. (NCT00429299)
Timeframe: At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27)

,,
InterventionPercentage of participants (Number)
Complete Response (CR)Partial Response (PR)Stable DiseaseProgressive DiseaseNot Evaluable
CT Plus Lapatinib 1500 mg15.844.713.12.623.7
CT Plus Trastuzumab30.541.75.52.819.4
CT Plus Trastuzumab and Lapatinib 1000 mg42.228.90028.9

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Number of Variations/Somatic Mutation in PI3KCA at Baseline

Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots). (NCT00429299)
Timeframe: Baseline

,,
InterventionVariations/Somatic mutations (Number)
PIK3CA Exon 9 Wild-TypePIK3CA Exon 9 MutationPIK3CA Exon 20 Wild-typePIK3CA Exon 20 Mutation
CT Plus Lapatinib 1500 mg352316
CT Plus Trastuzumab291255
CT Plus Trastuzumab and Lapatinib 1000 mg393375

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Number of Participants With Treatment Failure

Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause. (NCT00429299)
Timeframe: From randomization up to 29 weeks

InterventionParticipants (Number)
CT Plus Trastuzumab7
CT Plus Lapatinib 1500 mg9
CT Plus Trastuzumab and Lapatinib 1000 mg7

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Time to Treatment Failure From the Start of Primary Therapy

Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments. (NCT00429299)
Timeframe: From randomization up to Study Week 307

InterventionMonths (Median)
CT Plus Trastuzumab28.2
CT Plus Lapatinib 1500 mg39.6
CT Plus Trastuzumab and Lapatinib 1000 mg39.6

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Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS

The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported. (NCT00429299)
Timeframe: At Baseline and at surgery (up to Study Week 29)

,,
InterventionPercentage of participants (Number)
BCSMastectomyConversion from mastectomy to BCS
CT Plus Lapatinib 1500 mg57.939.542.8
CT Plus Trastuzumab66.733.361.9
CT Plus Trastuzumab and Lapatinib 1000 mg68.931.160

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Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment

The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal). (NCT00429299)
Timeframe: At Baseline and Withdrawal (assessed up to Study Week 29)

,,
InterventionPercentage of inhibition (Median)
Ki67, Baseline, n=34, 37, 42Ki67, Post-treatment, n=22, 21, 18pAKT, Baseline, n=34, 37, 42pAKT, Post-treatment, 18, 20, 17pMAPK, Baseline, n=9, 5, 7pMAPK, Post-treatment, n=0, 1, 2Tunel test, Baseline, n=25, 27, 31Tunel test, Post-treatment, n=7, 12, 11PTEN, Baseline, n=27, 35, 37PTEN, Post-treatment, n=14, 17, 15pEGFR, Baseline, n=21, 24, 28pEGFR, Post-treatment, n=5, 10, 11
CT Plus Lapatinib 1500 mg251510010700.580.1808000
CT Plus Trastuzumab25192.500NA0.40.18010000
CT Plus Trastuzumab and Lapatinib 1000 mg301000050.80.05908000

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Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment had been exercised in deciding whether reporting was appropriate in other situations. (NCT00429299)
Timeframe: From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29)

InterventionParticipants (Number)
CT Plus Trastuzumab35
CT Plus Lapatinib 1500 mg38
CT Plus Trastuzumab and Lapatinib 1000 mg46

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Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes

Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery. (NCT00429299)
Timeframe: At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)

InterventionPercentage of participants (Number)
CT Plus Trastuzumab25
CT Plus Lapatinib 1500 mg26.3
CT Plus Trastuzumab and Lapatinib 1000 mg46.7

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Clinical Response Rate

Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00432172)
Timeframe: Up to week 24

InterventionParticipants (Count of Participants)
Group 1 (Luminal A) Standard Treatment31
Group 1 (Luminal A) Selective Treatment23
Group 2 (Basal) Standard Treatment32
Group 2 (Basal) Selective Treatment36

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Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)

(NCT00454636)
Timeframe: Approximately 3.25 years

Interventionpercentage of participants (Number)
Cisplatin / Capecitabine2.4
Epirubicin / Cisplatin / Capecitabine6.3
Epirubicin / Oxaliplatin / Capecitabine3.7
Docetaxel / Cisplatin / Capecitabine5.2

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Overall Survival (OS)

OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventionmonths (Median)
Cisplatin / Capecitabine10.23
Epirubicin / Cisplatin / Capecitabine8.87
Epirubicin / Oxaliplatin / Capecitabine13.87
Docetaxel / Cisplatin / Capecitabine12.43

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Overall Response Rate (ORR)

ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventionpercentage of participants (Number)
Cisplatin / Capecitabine43.3
Epirubicin / Cisplatin / Capecitabine40.7
Epirubicin / Oxaliplatin / Capecitabine69.6
Docetaxel / Cisplatin / Capecitabine59.6

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Duration of Response

Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventiondays (Mean)
Cisplatin / Capecitabine308.92
Epirubicin / Cisplatin / Capecitabine154.09
Epirubicin / Oxaliplatin / Capecitabine203.06
Docetaxel / Cisplatin / Capecitabine205.52

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Time to Response

Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventiondays (Mean)
Cisplatin / Capecitabine132.92
Epirubicin / Cisplatin / Capecitabine126.64
Epirubicin / Oxaliplatin / Capecitabine123.50
Docetaxel / Cisplatin / Capecitabine138.16

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Progression-Free Survival (PFS)

PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00454636)
Timeframe: Approximately 3.25 years

Interventionmonths (Median)
Cisplatin / Capecitabine4.43
Epirubicin / Cisplatin / Capecitabine5.17
Epirubicin / Oxaliplatin / Capecitabine7.07
Docetaxel / Cisplatin / Capecitabine7.87

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Recurrence-free Survival

To determine the five-year RFS. (NCT00464646)
Timeframe: From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry

Interventionpercentage of patients (Number)
Cohort A75.97
Cohort B89.66

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Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)

The percentage of patients with surgical complications (from mastectomy, lumpectomy, and axillary staging procedures). (NCT00464646)
Timeframe: 2-4 weeks after surgery and at 9 and 12 months from study entry

InterventionParticipants (Count of Participants)
Cohort A37

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Overall Survival

Death from any cause during the 5 years from study entry. (NCT00464646)
Timeframe: From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry

InterventionParticipants (Count of Participants)
Cohort A12
Cohort B0

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Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)

The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy. (NCT00464646)
Timeframe: Assessed at time of surgery on average at 8 months

Interventionparticipants (Number)
Cohort A34

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Clinical Complete Response (cCR)

cCR following the last dose of docetaxel (Cohort A). cCR is detemined by tumor measurement by physical exam at baseline: target lesions greater than or equal to 2.0 cm; non-target lesions greater than or equal to 2.0 cm. cCR assessment at other timepoints: resolution of all target and non-target lesions identified at baseline, and no new lesions or other signs of disease progression. (NCT00464646)
Timeframe: Determined at baseline, 2-3 weeks after the last EC dose, 2-4 weeks after last Docetaxel dose-before surgery.

Interventionpercentage of patients (Number)
Cohort A61.43

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Number of Participants With Cardiac Events

The number of cardiac events defined as NYHA Class III/IV CHF and cardiac death.To determine the rate of cardiac events (NYHA Class III/IV CHF and cardiac death) of a regimen of EC followed by THA when administered to: Cohort A as neoadjuvant therapy for HER-2 positive locally advanced (clinical stage IIIA, IIIB or IIIC breast cancer or Cohort B as adjuvant therapy for resected HER2-positive pN2 or pN3 (pathologic stage III) breast cancer. The number of participants with one or more cardiac events are being reported. (NCT00464646)
Timeframe: Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.

InterventionParticipants (Count of Participants)
Cohort A4
Cohort B0

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Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)

(NCT00464646)
Timeframe: Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry

InterventionParticipants (Count of Participants)
Cohort A55
Cohort B22

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Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen.

The determination of pCR will be performed by the local pathologist following examination of tissue (breast and nodes) removed at the time of surgery. (NCT00464646)
Timeframe: Assessed at the time of surgery

InterventionParticipants (Count of Participants)
Cohort A36
Cohort B0

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Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours

Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present. (NCT00499603)
Timeframe: 48 hours after start of treatment

Interventionparticipants (Number)
Paclitaxel + FEC27
Paclitaxel + RAD001 + FEC22

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Participant Responses Per Treatment Arm at 12 Weeks

Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound. (NCT00499603)
Timeframe: 12 weeks

,
Interventionparticipants (Number)
CRPRSDPD
Paclitaxel + FEC35163
Paclitaxel + RAD001 + FEC011111

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Participant Responses Per Treatment Arm at 24 Weeks

Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound. (NCT00499603)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
CRPRSDPD
Paclitaxel + FEC41670
Paclitaxel + RAD001 + FEC21173

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Asymptomatic Decreases From Baseline in LVEF at Week 24

The summary of asymptomatic changed in LVEF. (NCT00513292)
Timeframe: Baseline, at 24 week

,
InterventionPercentage of Participants (Number)
no decrease or decrease < 10%, still above LLNdecrease < 10%, below lower limit of normal (LLN)decrease 10-15%, still above lower limit of normaldecrease 10-15%, below lower limit of normal (LLN)decrease > 15%, still above lower limit of normaldecrease > 15%, below lower limit of normal (LLN)
FEC-75 Then Paclitaxel/Trastuzumab83.30.87.92.41.64.0
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7573.13.115.40.86.90.8

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Breast Conservation

"Surgery was categorized as breast conserving surgery (Partial Mastectomy) or non-conserving surgery (Total Mastectomy or Modified Radical Mastectomy). Reported below is the percentage of patients receiving Partial Mastectomy. This was calculated by dividing the number of patients receiving Partial Mastectomy by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage)." (NCT00513292)
Timeframe: From time surgery to up to 5 years

Interventionpercentage of participants (Number)
FEC-75 Then Paclitaxel/Trastuzumab37.7
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7539.1

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Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week

Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)]. (NCT00513292)
Timeframe: Baseline, at 24 week

Interventionpercent (Median)
FEC-75 Then Paclitaxel/Trastuzumab-3
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75-4

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Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy

pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease). (NCT00513292)
Timeframe: Up to 5 years

InterventionPercentage (95% confidence Interval) (Number)
FEC-75 Then Paclitaxel/Trastuzumab48.3
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7546.7

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Disease-free Survival (DFS)

DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. (NCT00513292)
Timeframe: From time to registration to time of event, assessed up to 5 years

Interventionmonths (Median)
FEC-75 Then Paclitaxel/TrastuzumabNA
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75NA

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LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week

All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)]. (NCT00513292)
Timeframe: At 12 week

Interventionpercent (Median)
FEC-75 Then Paclitaxel/Trastuzumab2
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75-3

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Overall Survival (OS)

OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. (NCT00513292)
Timeframe: From time to registration to death, assessed up to 5 years

Interventionmonths (Median)
FEC-75 Then Paclitaxel/TrastuzumabNA
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75NA

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pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy

Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates. (NCT00513292)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
FEC-75 Then Paclitaxel/Trastuzumab56.5
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7554.2

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Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12

The summary of asymptomatic decrease in LVEF. (NCT00513292)
Timeframe: Baseline, at 12 week

,
InterventionPercentage of participants (Number)
no decrease or decrease < 10%, still above LLNdecrease < 10%, below lower limit of normal (LLN)decrease 10-15%, still above lower limit of normaldecrease 10-15%, below lower limit of normal (LLN)decrease > 15%, still above lower limit of normdecrease > 15%, below lower limit of normal
FEC-75 Then Paclitaxel/Trastuzumab92.30.86.200.80
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-7582.5011.702.92.9

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Percentage of Participants With Breast-Conserving Surgery

Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment. (NCT00559845)
Timeframe: Up to 7.5 years

Interventionpercentage of participants (Number)
Breast-conservingBreast-conserving Plus Axillary Dissection
Bevacizumab17.013.2

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Percentage of Participants With Disease-Free Interval

Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented. (NCT00559845)
Timeframe: Months 12, 24, 36, 48, and 60

Interventionpercentage of participants (Number)
12 Months24 Months36 Months48 Months60 Months
Bevacizumab92.284.380.476.576.5

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Objective Response Rate

Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions. (NCT00559845)
Timeframe: Up to 7.5 years

Interventionpercentage of participants (Number)
Bevacizumab59.0

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Percentage of Participants Experiencing Any Adverse Event

An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT00559845)
Timeframe: Up to 7.5 years

Interventionpercentage of participants (Number)
Bevacizumab100.0

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Percentage of Participants With Pathological Complete Response Following Principle Investigator Review

Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. (NCT00559845)
Timeframe: Up to 7.5 years

Interventionpercentage of participants (Number)
Bevacizumab23.2

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Overall Survival

Percent of participants with a 3-year survival. A survival rate greater than 50% would suggest efficacy and justify further study. (NCT00601705)
Timeframe: at 3 years from on study

Interventionpercentage of participants (Number)
Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery47

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Postoperative Adjuvant Chemoradiotherapy Feasibility

Ability to complete postoperative chemoradiotherapy. A threshold level of 65% was set and if less than this percentage completed the phase, it would be deemed unacceptable. The anticipation was that 53-patients would be evaluable for this end point. (NCT00601705)
Timeframe: Between 6 to 10 weeks postoperatively

InterventionParticipants (Count of Participants)
Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery48

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Locoregional Control and Distant Metastatic Control

A distant metastatic control rate of greater than 55 % would suggest efficacy for this treatment protocol. A locoregional control rate of less than 75% would suggest inefficacy. Locoregional control (LRC) defined by recurrence at the primary site or in regional lymph nodes and distant metastatic control (DMC), defined by recurrence in a distant site. (NCT00601705)
Timeframe: at 3 years from on study

InterventionParticipants (Count of Participants)
Locoregional ControlDistant Metastatic Control
Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery429

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Pathological Response Rate

"Percent of participants with a clinical response:~Complete pathologic response is defined as the complete disappearance of all viable tumor in the surgical specimen.~Partial pathologic response is defined as any improvement in the pathologically determined T or N stage (without reciprocal deterioration in N or T) or a resolution of M1a disease, when compared to the pretreatment esophageal ultrasound-determined clinical stage. A partial response will not be defined based only on shrinkage of a measurable lesion unless there is improvement in the TNM stage.~Stable pathologic disease is defined as no change in the pathologically determined TNM stage when compared to the pretreatment esophageal ultrasound.~Progressive pathologic disease is defined as any increase in the T or N stage irrespective of any reciprocal improvement in N or T, or as the development of new areas of malignancy or metastases." (NCT00601705)
Timeframe: after completion of study at 35 weeks

Interventionparticipants (Number)
Complete responsePartial responseStable diseaseProgressive disease
Epirubicin, Oxaliplatin and Fluorouracil3211420

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Feasibility of Induction Chemoradiotherapy as Measured by Resectability Rate

Feasibility of induction chemoradiotherapy as measured by resectability in greater than 75% of participants. The number of participants that were resectable. (NCT00601705)
Timeframe: at 12 weeks from on study

InterventionParticipants (Count of Participants)
Epirubicin, Oxaliplatin, 5-fluorouracil, and Surgery54

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Clinical Response Rate

"Percent of participants with a clinical response:~Complete clinical response is defined as the complete disappearance of all clinical evidence of tumor.~Partial clinical response is defined as any improvement in the clinically determined T or N stage (without reciprocal deterioration in N or T) or a resolution of M1a disease, when compared to the pretreatment clinical stage. A partial response will not be defined based only on shrinkage of a measurable lesion unless there is improvement in the TNM stage.~Stable clinical disease is defined as no change in the clinical TNM stage when compared to the pretreatment clinical stage.~Progressive clinical disease is defined as any increase in the T or N stage irrespective of any reciprocal improvement in N or T, or as the development of new areas of malignancy or metastases." (NCT00601705)
Timeframe: at 12 weeks from on study

Interventionpercentage of participants (Number)
Complete responsePartial responseStable diseaseProgressive disease
Epirubicin, Oxaliplatin and Fluorouracil0483319

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Number of Disease-free Survival Events for Triple-negative Subgroup

DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only. (NCT00630032)
Timeframe: At 5 years

InterventionEvents (Number)
Docetaxel69
Ixabepilone50

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Number of Distant Metastasis-free Survival Events for the Whole Population

The distant metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body. (NCT00630032)
Timeframe: At 5 years

InterventionEvents (Number)
Docetaxel82.3
Ixabepilone87.7

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Number of Event-free Survival

The Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first. (NCT00630032)
Timeframe: At 5 years

InterventionEvents (Number)
Docetaxel77.46
Ixabepilone81.53

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Overall Survival

The overall survival is the length of time from randomization that patients enrolled in the study are still alive. (NCT00630032)
Timeframe: At 5 years

Interventionpercentage of participants (Number)
Docetaxel87.00
Ixabepilone87.60

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Percentage of Participants With Disease-free Survival (DFS)

DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first (NCT00630032)
Timeframe: At 5 years

InterventionPercentage of participants (Number)
Docetaxel78.97
Ixabepilone83.37

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Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup

DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only. (NCT00630032)
Timeframe: At 5 years

InterventionEvents (Number)
Docetaxel21
Ixabepilone17

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Overall Survival

Overall survival (OS) is the duration from start of treatment to time of death from any cause. (NCT00667420)
Timeframe: duration from enrollment to death (up to 6 years)

Interventionmonths (Median)
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab TreatmentNA

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Pathologic Complete Response Rate

For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined. (NCT00667420)
Timeframe: at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)

Interventionparticipants (Number)
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment0

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Progression-Free Survival

measured from the first day of treatment to the day when conclusive evidence of new disease is found (NCT00667420)
Timeframe: up to 72 months

Interventionmonths (Mean)
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment27.2

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R0 Resection Rate

percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection (NCT00667420)
Timeframe: time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy

Interventionpercentage of participants (Number)
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment52.9

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Safety and Tolerability

Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy (NCT00667420)
Timeframe: after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)

Interventionparticipants (Number)
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment14

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Overall Response Will be Characterized by the Patient's FDG-PET Scan

A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline. (NCT00737438)
Timeframe: 2 years

Interventionparticipants (Number)
Metabolic ResponderNon-Metabolic Responder
All Patients119

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Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy. (NCT00756470)
Timeframe: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)

InterventionPercentage of Participants (Number)
Neoadjuvant Lapatinib Plus Chemotherapy6.6

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Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)

Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery. (NCT00756470)
Timeframe: Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)

Interventionparticipants (Number)
RCB Class 0 (pCR)RCB Class IRCB Class IIRCB Class III
Neoadjuvant Lapatinib Plus Chemotherapy1090

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Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).

Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D. (NCT00841828)
Timeframe: Up to 16 weeks

Interventionpercentage of participants with pCR (Number)
Arm 1: EC -> D + Lapatinib23.5
Arm 2: EC -> D + Trastuzumab47.9

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Overall Clinical Response Rate (ORR)

"Overall clinical response was evaluated according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria (Therasse et al, 2000). Is defined as the sum of Complete responses plus Partial responses.~It was evaluated after the fourth EC cycle and before surgery using ultrasound, mammography, or MRI." (NCT00841828)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
Arm 1: EC -> D + Lapatinib62.7
Arm 2: EC -> D + Trastuzumab77.1

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Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline

Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter (SD) of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method. (NCT00950300)
Timeframe: Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)

Interventionpercentage of participants (Number)
Herceptin IV + Chemotherapy88.8
Herceptin SC + Chemotherapy87.2

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Percentage of Participants Who Experienced a Protocol-Defined Event

Protocol-defined events included disease recurrence/progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. The percentage of participants who experienced a protocol-defined event at any time during the study was reported. (NCT00950300)
Timeframe: Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)

Interventionpercentage of participants (Number)
Herceptin IV + Chemotherapy33.3
Herceptin SC + Chemotherapy32.7

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Percentage of Participants Who Died

The percentage of participants who died at any time during the study was reported. (NCT00950300)
Timeframe: Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)

Interventionpercentage of participants (Number)
Herceptin IV + Chemotherapy14.5
Herceptin SC + Chemotherapy13.6

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Overall Survival (OS)

OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause. (NCT00950300)
Timeframe: Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)

Interventionmonths (Median)
Herceptin IV + ChemotherapyNA
Herceptin SC + ChemotherapyNA

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Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery

Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL). (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)

Interventionμg/mL (Mean)
Herceptin IV + Chemotherapy57.8
Herceptin SC + Chemotherapy78.7

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Observed Ctrough of Trastuzumab After Surgery

Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)

Interventionμg/mL (Mean)
Herceptin IV + Chemotherapy62.1
Herceptin SC + Chemotherapy90.4

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Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery

Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough >20 μg/mL was reported. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)

Interventionparticipants (Number)
Herceptin IV + Chemotherapy232
Herceptin SC + Chemotherapy227

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Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery

Pre-dose samples were obtained after surgery (Cycle 13). The number of participants who had an observed Ctrough >20 μg/mL was reported. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)

Interventionparticipants (Number)
Herceptin IV + Chemotherapy216
Herceptin SC + Chemotherapy227

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Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery

PK samples were obtained prior to surgery (Cycle 7). The Cmax during Cycle 7 was recorded, averaged among all participants, and expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)

Interventionμg/mL (Mean)
Herceptin IV + Chemotherapy221
Herceptin SC + Chemotherapy149

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Event-Free Survival (EFS)

Protocol-defined events included disease recurrence or progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event. (NCT00950300)
Timeframe: Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)

Interventionmonths (Median)
Herceptin IV + ChemotherapyNA
Herceptin SC + ChemotherapyNA

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Cmax of Trastuzumab After Surgery

PK samples were obtained after surgery (Cycle 12). The Cmax during Cycle 12 was recorded, averaged among all participants, and expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)

Interventionμg/mL (Mean)
Herceptin IV + Chemotherapy230
Herceptin SC + Chemotherapy166

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AUC21d of Trastuzumab After Surgery

PK samples were obtained after surgery (Cycle 12). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 12 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in d*μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)

Interventiond*μg/mL (Mean)
Herceptin IV + Chemotherapy2179
Herceptin SC + Chemotherapy2610

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Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery

PK samples were obtained prior to surgery (Cycle 7). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 7 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in days multiplied by micrograms per milliliters (d*μg/mL). (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)

Interventiond*μg/mL (Mean)
Herceptin IV + Chemotherapy2056
Herceptin SC + Chemotherapy2268

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Predicted Ctrough of Trastuzumab Prior to Surgery

Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)

Interventionμg/mL (Mean)
Herceptin IV + Chemotherapy51.4
Herceptin SC + Chemotherapy80.3

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Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab

"Participants provided PK samples for evaluation of anti-trastuzumab antibodies. The number of participants with Treatment-induced ADAs and Treatment-enhanced ADA against trastuzumab at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer)." (NCT00950300)
Timeframe: Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18

,
Interventionparticipants (Number)
Treatment-induced ADAsTreatment-enhanced ADA
Herceptin IV + Chemotherapy282
Herceptin SC + Chemotherapy461

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Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)

"Participants in the Herceptin SC arm provided PK samples for evaluation of anti-rHuPH20 antibodies. The number of participants with Treatment-induced ADAs and Treatment-enhanced ADA against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer)." (NCT00950300)
Timeframe: Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18

Interventionparticipants (Number)
Treatment-induced ADATreatment-enhanced ADA
Herceptin SC + Chemotherapy4913

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Tmax of Trastuzumab After Surgery

PK samples were obtained after surgery (Cycle 12). The Tmax during Cycle 12 was recorded, averaged among all participants, and expressed in days. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)

Interventiondays (Mean)
Herceptin IV + Chemotherapy0.06
Herceptin SC + Chemotherapy4.08

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Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline

Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm with no prior assessment of PD. PR was defined as ≥30% decrease from Baseline in SD of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. Time to response was defined as the time from first dose of study medication to the first assessment of CR or PR, which was the date the response was first documented by objective evidence, among participants with an overall response of CR or PR. (NCT00950300)
Timeframe: Tumor assessments at Baseline; on Day 1 Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of chemotherapy (approximately 6 months overall)

Interventionweeks (Median)
Herceptin IV + Chemotherapy6.14
Herceptin SC + Chemotherapy6.14

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Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery

PK samples were obtained prior to surgery (Cycle 7). The Tmax during Cycle 7 was recorded, averaged among all participants, and expressed in days. (NCT00950300)
Timeframe: Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)

Interventiondays (Mean)
Herceptin IV + Chemotherapy0.05
Herceptin SC + Chemotherapy4.12

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Predicted Ctrough of Trastuzumab After Surgery

Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL. (NCT00950300)
Timeframe: Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)

Interventionμg/mL (Mean)
Herceptin IV + Chemotherapy51.7
Herceptin SC + Chemotherapy80.6

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Percentage of Participants With Total Pathological Complete Response (tpCR)

Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method. (NCT00950300)
Timeframe: After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)

Interventionpercentage of participants (Number)
Herceptin IV + Chemotherapy34.2
Herceptin SC + Chemotherapy39.2

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Percentage of Participants With Pathological Complete Response (pCR)

Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method. (NCT00950300)
Timeframe: After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)

Interventionpercentage of participants (Number)
Herceptin IV + Chemotherapy40.7
Herceptin SC + Chemotherapy45.4

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Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response

Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD). (NCT00954512)
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)

,,,,
InterventionParticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Assessable (NA)Incomplete Response/Stable Disease (IR/SD)
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab000200
Regimen B: Carboplatin + Paclitaxel + Robatumumab002100
Regimen D: Trastuzumab + Robatumumab001100
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab002100
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab001100

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Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. (NCT00954512)
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)

InterventionParticipants (Number)
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab2
Regimen B: Carboplatin + Paclitaxel + Robatumumab3
Regimen D: Trastuzumab + Robatumumab2
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab4
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab4

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Number of Participants That Achieved Pathologic Complete Response (CR)

Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field. (NCT01036087)
Timeframe: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).

InterventionParticipants (Count of Participants)
PNC + FEC11

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Percentage of Participants With Disease Free Survival (DFS)

Percentage of participants with DFS who completed 5 year follow-up visit. (NCT01061359)
Timeframe: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

InterventionPercentage of participants (Number)
Epirubicin83.7

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Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1410000
Cohort A-Placebo Group420001
Cohort B-GSK2302024A Group900000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1001000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1311000
Cohort A-Placebo Group600001
Cohort B-GSK2302024A Group900000
Cohort B-Placebo Group510000
Cohort C-GSK2302024A Group920000
Cohort C-Placebo Group310000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1230000
Cohort A-Placebo Group600001
Cohort B-GSK2302024A Group531000
Cohort B-Placebo Group411000
Cohort C-GSK2302024A Group1010000
Cohort C-Placebo Group310000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1500000
Cohort A-Placebo Group600001
Cohort B-GSK2302024A Group901000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1010000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and post 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1500000
Cohort A-Placebo Group600001
Cohort B-GSK2302024A Group540000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1100000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group951000
Cohort A-Placebo Group421000
Cohort B-GSK2302024A Group035100
Cohort B-Placebo Group022200
Cohort C-GSK2302024A Group235100
Cohort C-Placebo Group111100
Cohort D-GSK2302024A-D14 Group112004

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Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1500000
Cohort A-Placebo Group700000
Cohort B-GSK2302024A Group900000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1100000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group400004

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Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1230000
Cohort A-Placebo Group601000
Cohort B-GSK2302024A Group711000
Cohort B-Placebo Group510000
Cohort C-GSK2302024A Group1010000
Cohort C-Placebo Group300100
Cohort D-GSK2302024A-D14 Group001034

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Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1410000
Cohort A-Placebo Group610000
Cohort B-GSK2302024A Group810000
Cohort B-Placebo Group510000
Cohort C-GSK2302024A Group551000
Cohort C-Placebo Group220000
Cohort D-GSK2302024A-D14 Group220004

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Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Any SAE(s) Grade 1Any SAE(s) Grade 2Any SAE(s) Grade 3Any SAE(s) Grade 4Any SAE(s) Grade 5Any SAE(s)
Cohort A-GSK2302024A Group012003
Cohort A-Placebo Group000000
Cohort B-GSK2302024A Group010214
Cohort B-Placebo Group001102
Cohort C-GSK2302024A Group001405
Cohort C-Placebo Group000101
Cohort D-GSK2302024A-D14 Group001405

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Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1320000
Cohort A-Placebo Group700000
Cohort B-GSK2302024A Group621000
Cohort B-Placebo Group321000
Cohort C-GSK2302024A Group740000
Cohort C-Placebo Group211000
Cohort D-GSK2302024A-D14 Group010304

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Number of Patients With Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

InterventionSubjects (Number)
Cohort A-GSK2302024A Group15
Cohort A-Placebo Group5
Cohort B-GSK2302024A Group9
Cohort B-Placebo Group6
Cohort C-GSK2302024A Group11
Cohort C-Placebo Group4
Cohort D-GSK2302024A-D14 Group7

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Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response

For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-administration antibody concentration. (NCT01220128)
Timeframe: At post-GSK2302024A/placebo Dose 4 (Week 13)

InterventionSubjects (Number)
Cohort A-GSK2302024A Group10
Cohort A-Placebo Group0
Cohort B-GSK2302024A Group0
Cohort B-Placebo Group0
Cohort C-GSK2302024A Group6
Cohort C-Placebo Group0
Cohort D-GSK2302024A-D14 Group2

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Number of Subjects With Serious Adverse Events SAE(s)

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE. (NCT01220128)
Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)

InterventionSubjects (Number)
Cohort A-GSK2302024A Group3
Cohort A-Placebo Group0
Cohort B-GSK2302024A Group4
Cohort B-Placebo Group2
Cohort C-GSK2302024A Group5
Cohort C-Placebo Group1
Cohort D-GSK2302024A-D14 Group5

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Number of Subjects With Severe Toxicities

Severe toxicity was defined as follows: - A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo - A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks. - A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo. - A Grade 2 or higher allergic reaction occurring within 24 hours following the administration. - A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration. - A decrease in renal function at the time of administration that was considered as related or possibly related. (NCT01220128)
Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)

InterventionSubjects (Number)
Cohort A-GSK2302024A Group0
Cohort A-Placebo Group0
Cohort B-GSK2302024A Group1
Cohort B-Placebo Group0
Cohort C-GSK2302024A Group1
Cohort C-Placebo Group0
Cohort D-GSK2302024A-D14 Group0

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Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Any AE(s) Grade 1Any AE(s) Grade 2Any AE(s) Grade 3Any AE(s) Grade 4Any AE(s) Grade 5Any AE(s)
Cohort A-GSK2302024A Group6630015
Cohort A-Placebo Group140005
Cohort B-GSK2302024A Group060219
Cohort B-Placebo Group005106
Cohort C-GSK2302024A Group0434011
Cohort C-Placebo Group030104
Cohort D-GSK2302024A-D14 Group021407

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Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1220001
Cohort A-Placebo Group510001
Cohort B-GSK2302024A Group810000
Cohort B-Placebo Group420000
Cohort C-GSK2302024A Group650000
Cohort C-Placebo Group220000
Cohort D-GSK2302024A-D14 Group120005

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Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1050000
Cohort A-Placebo Group510001
Cohort B-GSK2302024A Group810000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group740000
Cohort C-Placebo Group310000
Cohort D-GSK2302024A-D14 Group120005

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Number of Subjects With Anemia, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1221000
Cohort A-Placebo Group700000
Cohort B-GSK2302024A Group170100
Cohort B-Placebo Group040000
Cohort C-GSK2302024A Group074000
Cohort C-Placebo Group031000
Cohort D-GSK2302024A-D14 Group220004

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Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1231000
Cohort A-Placebo Group420001
Cohort B-GSK2302024A Group810000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group740000
Cohort C-Placebo Group130000
Cohort D-GSK2302024A-D14 Group210005

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Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1500000
Cohort A-Placebo Group510001
Cohort B-GSK2302024A Group900000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1100000
Cohort C-Placebo Group201100
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Breast Cancer Pathological Response

The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present. (NCT01220128)
Timeframe: During the treatment period, up to Week 26/32

,,,,,,
InterventionSubjects (Number)
Partial resposeComplete response
Cohort A-GSK2302024A Group40
Cohort A-Placebo Group30
Cohort B-GSK2302024A Group50
Cohort B-Placebo Group32
Cohort C-GSK2302024A Group36
Cohort C-Placebo Group13
Cohort D-GSK2302024A-D14 Group31

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Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1140004
Cohort A-Placebo Group420001
Cohort B-GSK2302024A Group810000
Cohort B-Placebo Group510000
Cohort C-GSK2302024A Group1010000
Cohort C-Placebo Group310000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1500000
Cohort A-Placebo Group610000
Cohort B-GSK2302024A Group900000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1100000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group400004

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Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1410003
Cohort A-Placebo Group330001
Cohort B-GSK2302024A Group810000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1100000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group300005

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Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5). (NCT01220128)
Timeframe: During the treatment period and up to 30 days post last administration

,,,,,,
InterventionSubjects (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade Unknown
Cohort A-GSK2302024A Group1500000
Cohort A-Placebo Group510001
Cohort B-GSK2302024A Group711000
Cohort B-Placebo Group600000
Cohort C-GSK2302024A Group1010000
Cohort C-Placebo Group400000
Cohort D-GSK2302024A-D14 Group300005

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Percentage of Participants With Secondary Cardiac Event

Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB). (NCT01358877)
Timeframe: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy2.7
Placebo + Trastuzumab + Chemotherapy2.8

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Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence. (NCT01358877)
Timeframe: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy5.8
Placebo + Trastuzumab + Chemotherapy7.2

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Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event. (NCT01358877)
Timeframe: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy7.1
Placebo + Trastuzumab + Chemotherapy8.7

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Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). (NCT01358877)
Timeframe: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy7.9
Placebo + Trastuzumab + Chemotherapy9.6

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Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence. (NCT01358877)
Timeframe: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy5.0
Placebo + Trastuzumab + Chemotherapy6.0

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Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. (NCT01358877)
Timeframe: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy8.0
Placebo + Trastuzumab + Chemotherapy9.8

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Percentage of Participants Who Died

Percentage of participants who died due to any cause is reported. (NCT01358877)
Timeframe: Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy3.3
Placebo + Trastuzumab + Chemotherapy3.7

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Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence. (NCT01358877)
Timeframe: 3 years

InterventionEstimate of percentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy95.18
Placebo + Trastuzumab + Chemotherapy94.27

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Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). (NCT01358877)
Timeframe: 3 years

InterventionEstimate of percentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy93.50
Placebo + Trastuzumab + Chemotherapy92.51

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Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. (NCT01358877)
Timeframe: 3 years

InterventionEstimate of percentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy94.06
Placebo + Trastuzumab + Chemotherapy93.24

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Trough Serum Concentration (Cmin) of Pertuzumab

(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cycle 1Cycle 10Cycle 15
Pertuzumab + Trastuzumab + Chemotherapy68.088.195.5

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Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence. (NCT01358877)
Timeframe: 3 years

InterventionEstimate of percentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy95.70
Placebo + Trastuzumab + Chemotherapy95.13

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Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. (NCT01358877)
Timeframe: 3 years

InterventionEstimate of percentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy93.42
Placebo + Trastuzumab + Chemotherapy92.29

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Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3

The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. (NCT01358877)
Timeframe: 3 years

InterventionEstimate of percentage of participants (Number)
Pertuzumab + Trastuzumab + Chemotherapy97.65
Placebo + Trastuzumab + Chemotherapy97.67

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Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionpercentage of participants (Number)
Baseline: No pain/discomfortBaseline: Moderate pain/discomfortBaseline: Extreme pain/discomfortWeek 13: No pain/discomfortWeek 13: Moderate pain/discomfortWeek 13: Extreme pain/discomfortWeek 25: No pain/discomfortWeek 25: Moderate pain/discomfortWeek 25: Extreme pain/discomfortEOT: No pain/discomfortEOT: Moderate pain/discomfortEOT: Extreme pain/discomfortFU Month 18: No pain/discomfortFU Month 18: Moderate pain/discomfortFU Month 18: Extreme pain/discomfortFU Month 24: No pain/discomfortFU Month 24: Moderate pain/discomfortFU Month 24: Extreme pain/discomfortFU Month 36: No pain/discomfortFU Month 36: Moderate pain/discomfortFU Month 36: Extreme pain/discomfort
Pertuzumab + Trastuzumab + Chemotherapy49.050.01.044.652.72.744.353.32.449.348.52.251.346.62.156.741.31.959.538.91.6
Placebo + Trastuzumab + Chemotherapy49.049.71.340.556.53.043.754.41.950.047.62.453.144.72.156.041.52.557.840.12.1

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Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionpercentage of participants (Number)
Baseline: Not anxious/depressBaseline: Moderate anxious/depressBaseline: Extreme anxious/depressWeek 13: Not anxious/depressWeek 13: Moderate anxious/depressWeek 13: Extreme anxious/depressWeek 25: No anxious/depressWeek 25: Moderate anxious/depressWeek 25: Extreme anxious/depressEOT: Not anxious/depressEOT: Moderate anxious/depressEOT: Extreme anxious/depressFU Month 18: Not anxious/depressFU Month 18: Moderate anxious/depressFU Month 18: Extreme anxious/depressFU Month 24: Not anxious/depressFU Month 24: Moderate anxious/depressFU Month 24: Extreme anxious/depressFU Month 36: Not anxious/depressFU Month 36: Moderate anxious/depressFU Month 36: Extreme anxious/depress
Pertuzumab + Trastuzumab + Chemotherapy47.149.43.553.643.43.055.541.92.558.538.92.661.436.22.463.833.82.464.033.32.6
Placebo + Trastuzumab + Chemotherapy44.750.15.252.444.03.755.541.82.758.339.12.659.937.03.161.036.22.861.635.43.0

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Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionpercentage of participants (Number)
Baseline: No problemsBaseline: Some problemsBaseline: UnableWeek 13: No problemsWeek 13: Some problemsWeek 13: UnableWeek 25: No problemsWeek 25: Some problemsWeek 25: UnableEOT: No problemsEOT: Some problemsEOT: UnableFU Month 18: No problemsFU Month 18: Some problemsFU Month 18: UnableFU Month 24: No problemsFU Month 24: Some problemsFU Month 24: UnableFU Month 36: No problemsFU Month 36: Some problemsFU Month 36: Unable
Pertuzumab + Trastuzumab + Chemotherapy89.710.00.394.35.30.495.54.30.195.44.40.297.22.60.296.92.80.397.32.50.2
Placebo + Trastuzumab + Chemotherapy90.79.10.293.26.40.495.04.70.395.84.00.296.03.60.396.33.50.396.53.20.3

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Percentage of Participants With Primary Cardiac Event

Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. (NCT01358877)
Timeframe: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)

,
Interventionpercentage of participants (Number)
Primary Cardiac Event (Composite)Heart Failure and LVEF DeclineCardiac Death (Definite or Probable)
Pertuzumab + Trastuzumab + Chemotherapy0.70.60.1
Placebo + Trastuzumab + Chemotherapy0.30.20.1

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Peak Serum Concentration (Cmax) of Pertuzumab

(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

Interventionmcg/mL (Mean)
Cycle 1Cycle 10Cycle 15
Pertuzumab + Trastuzumab + Chemotherapy237222206

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Cmin of Trastuzumab

(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

,
Interventionmcg/mL (Mean)
Cycle 1Cycle 10Cycle 15
Pertuzumab + Trastuzumab + Chemotherapy32.165.072.9
Placebo + Trastuzumab + Chemotherapy34.168.471.0

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Cmax of Trastuzumab

(NCT01358877)
Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

,
Interventionmcg/mL (Mean)
Cycle 1Cycle 10Cycle 15
Pertuzumab + Trastuzumab + Chemotherapy180219187
Placebo + Trastuzumab + Chemotherapy190225234

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Change From Baseline in LVEF to Worst Post-Baseline Value

LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan. (NCT01358877)
Timeframe: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)

,
Interventionpercentage of blood pumped out (Mean)
BaselineChange to Worst Value
Pertuzumab + Trastuzumab + Chemotherapy65.2-7.5
Placebo + Trastuzumab + Chemotherapy65.3-7.6

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36

,
Interventionunits on a scale (Mean)
BaselineChange at Week 13Change at Week 25Change at EOTChange at FU Month 18Change at FU Month 24Change at FU Month 36
Pertuzumab + Trastuzumab + Chemotherapy72.9-11.2-4.4-3.11.92.22.8
Placebo + Trastuzumab + Chemotherapy72.5-10.2-2.9-1.11.32.41.8

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Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionunits on a scale (Mean)
Baseline: PhysicalChange at Week 13: PhysicalChange at Week 25: PhysicalChange at EOT: PhysicalChange at FU Month 18: PhysicalChange at FU Month 24: PhysicalChange at FU Month 36: PhysicalBaseline: RoleChange at Week 13: RoleChange at Week 25: RoleChange at EOT: RoleChange at FU Month 18: RoleChange at FU Month 24: RoleChange at FU Month 36: RoleBaseline: SocialChange at Week 13: SocialChange at Week 25: SocialChange at EOT: SocialChange at FU Month 18: SocialChange at FU Month 24: SocialChange at FU Month 36: SocialBaseline: CognitiveChange at Week 13: CognitiveChange at Week 25: CognitiveChange at EOT: CognitiveChange at FU Month 18: CognitiveChange at FU Month 24: CognitiveChange at FU Month 36: CognitiveBaseline: EmotionalChange at Week 13: EmotionalChange at Week 25: EmotionalChange at EOT: EmotionalChange at FU Month 18: EmotionalChange at FU Month 24: EmotionalChange at FU Month 36: Emotional
Pertuzumab + Trastuzumab + Chemotherapy89.6-10.7-4.6-4.1-0.9-0.4-0.379.8-8.0-0.70.46.17.37.981.9-8.7-2.20.05.05.56.688.8-9.1-7.6-7.7-6.1-6.2-5.472.83.35.15.67.77.87.8
Placebo + Trastuzumab + Chemotherapy89.1-10.6-4.3-3.2-0.9-0.3-0.179.4-8.50.42.35.76.97.680.6-7.8-0.71.24.86.57.187.9-9.0-7.0-7.2-5.8-5.5-4.971.32.95.96.27.68.58.4

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Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionunits on a scale (Mean)
BaselineChange at Week 13Change at Week 25Change at EOTChange at FU Month 18Change at FU Month 24Change at FU Month 36
Pertuzumab + Trastuzumab + Chemotherapy20.33.12.3-0.2-4.1-5.2-7.1
Placebo + Trastuzumab + Chemotherapy22.11.7-0.3-1.5-5.1-6.9-8.3

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Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionunits on a scale (Mean)
Baseline:Systemic SEChange at Week 13: Systemic SEChange at Week 25: Systemic SEChange at EOT: Systemic SEChange at FU Month 18: Systemic SEChange at FU Month 24: Systemic SEChange at FU Month 36: Systemic SEBaseline: Hair LossChange at Week 13: Hair LossChange at Week 25: Hair LossChange at EOT: Hair LossChange at FU Month 18: Hair LossChange at FU Month 24: Hair LossChange at FU Month 36: Hair LossBaseline: Arm SymptomsChange at Week 13: Arm SymptomsChange at Week 25: Arm SymptomsChange at EOT: Arm SymptomsChange at FU Month 18: Arm SymptomsChange at FU Month 24: Arm SymptomsChange at FU Month 36: Arm SymptomsBaseline: Breast SymptomsChange at Week 13: Breast SymptomsChange at Week 25: Breast SymptomsChange at EOT: Breast SymptomsChange at FU Month 18: Breast SymptomsChange at FU Month 24: Breast SymptomsChange at FU Month 36: Breast Symptoms
Pertuzumab + Trastuzumab + Chemotherapy9.521.19.28.34.44.14.526.417.38.310.9-7.0-4.1-5.621.6-4.7-2.9-3.5-4.0-5.1-5.919.5-5.01.9-0.6-3.0-6.4-7.3
Placebo + Trastuzumab + Chemotherapy10.221.78.27.55.54.95.222.121.214.517.93.20.72.421.7-2.1-2.3-3.4-3.9-5.0-4.720.4-5.2-0.4-3.8-5.9-7.3-7.9

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Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionunits on a scale (Mean)
Baseline: Body ImageChange at Week 13: Body ImageChange at Week 25: Body ImageChange at EOT: Body ImageChange at FU Month 18: Body ImageChange at FU Month 24: Body ImageChange at FU Month 36: Body ImageBaseline: Sexual EnjoymentChange at Week 13: Sexual EnjoymentChange at Week 25: Sexual EnjoymentChange at EOT: Sexual EnjoymentChange at FU Month 18: Sexual EnjoymentChange at FU Month 24: Sexual EnjoymentChange at FU Month 36: Sexual EnjoymentBaseline: Sexual FunctionChange at Week 13: Sexual FunctionChange at Week 25: Sexual FunctionChange at EOT: Sexual FunctionChange at FU Month 18: Sexual FunctionChange at FU Month 24: Sexual FunctionChange at FU Month 36: Sexual FunctionBaseline: FPChange at Week 13: FPChange at Week 25: FPChange at EOT: FPChange at FU Month 18: FPChange at FU Month 24 : FPChange at FU Month 36: FP
Pertuzumab + Trastuzumab + Chemotherapy79.7-12.9-7.6-4.9-0.10.51.754.0-16.5-11.9-10.7-4.2-6.0-5.319.6-5.6-2.6-1.02.52.82.651.33.16.37.712.913.714.7
Placebo + Trastuzumab + Chemotherapy78.9-13.9-7.3-6.0-1.30.10.755.0-13.1-7.9-8.0-6.7-5.0-6.020.8-6.6-2.3-1.41.41.81.650.51.85.46.910.512.913.6

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Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionpercentage of participants (Number)
Baseline: No problemsBaseline: Some problemsBaseline: Confined to bedWeek 13: No problemsWeek 13: Some problemsWeek 13: Confined to bedWeek 25: No problemsWeek 25: Some problemsWeek 25: Confined to bedEOT: No problemsEOT: Some problemsEOT: Confined to bedFU Month 18: No problemsFU Month 18: Some problemsFU Month 18: Confined to bedFU Month 24: No problemsFU Month 24: Some problemsFU Month 24: Confined to bedFU Month 36: No problemsFU Month 36: Some problemsFU Month 36: Confined to bed
Pertuzumab + Trastuzumab + Chemotherapy93.86.20.077.522.10.483.816.10.185.114.80.188.811.20.187.812.10.188.511.50.0
Placebo + Trastuzumab + Chemotherapy92.96.90.274.824.80.482.717.20.184.914.90.287.012.80.287.712.10.187.812.10.1

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Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding. (NCT01358877)
Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

,
Interventionpercentage of participants (Number)
Baseline: No problemsBaseline: Some problemsBaseline: UnableWeek 13: No problemsWeek 13: Some problemsWeek 13: UnableWeek 25: No problemsWeek 25: Some problemsWeek 25: UnableEOT: No problemsEOT: Some problemsEOT: UnableFU Month 18: No problemsFU Month 18: Some problemsFU Month 18: UnableFU Month 24: No problemsFU Month 24: Some problemsFU Month 24: UnableFU Month 36: No problemsFU Month 36: Some problemsFU Month 36: Unable
Pertuzumab + Trastuzumab + Chemotherapy67.430.42.256.840.13.166.532.21.272.426.31.378.520.60.978.720.40.980.918.30.7
Placebo + Trastuzumab + Chemotherapy66.132.21.754.143.02.965.832.71.472.526.60.976.323.00.779.119.71.179.819.40.8

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Overall Survival (OS)

(NCT01593020)
Timeframe: from start of treatment, up to 5 years

Interventionpercentage of participants (Number)
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC100
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC84.4

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5 Year Event Free Survival (EFS)

Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay. (NCT01593020)
Timeframe: from start of treatment, up to 5 years

Interventionpercentage of participants (Number)
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC81.8
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC74

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Pathologic Complete Response (pCR)

Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response. (NCT01593020)
Timeframe: 4 -6 weeks from last dose of FAC/FEC-regimen.

InterventionParticipants (Count of Participants)
Paclitaxel Weekly for 12 Doses Followed by FAC/FEC7
Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC1

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Death Rate

(NCT01779050)
Timeframe: Up to 3 years after completion of treatment (estimated to be 4 years)

InterventionParticipants (Count of Participants)
Arm I (Definitive Therapy)1
Arm II (Definitive Therapy, Trastuzumab)0

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Number of Participants With Disease Recurrence

-Disease recurrence is defined as the documented appearance of local (breast, chest wall, axillary, supraclavicular nodes) or distant disease. (NCT01779050)
Timeframe: Up to 3 years after completion of treatment (estimated to be 4 years)

InterventionParticipants (Count of Participants)
Arm I (Definitive Therapy)1
Arm II (Definitive Therapy, Trastuzumab)0

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Residual Cancer Burden Score

To assess cancer burben, the Residual Cancer Burden (RCB) score was used. This score has a range of 0 - III, where III (3) is the worst level of burden. (NCT01855828)
Timeframe: Up to 28 weeks

InterventionParticipants (Count of Participants)
RCB = 0RCB = I (1)RCB = II (2)RCB = III (3)
Chemo Plus Pertuzumab,Trastuzumab28544

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Count of Patients With Clinical Response

To assess clinical response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, the number of patients are presented with a clinical response. (NCT01855828)
Timeframe: Up to 28 weeks

InterventionParticipants (Count of Participants)
Chemo Plus Pertuzumab,Trastuzumab HR-positive6
Chemo Plus Pertuzumab,Trastuzumab HR-negative20

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Proportion of Participants With a Pathologic Complete Response Rate

To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen. (NCT01855828)
Timeframe: 20 weeks

Interventionproportion of participants (Number)
HR PositiveHR Negative
Chemo Plus Pertuzumab,Trastuzumab.26.80

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Cardiac Safety

To assess the safety of the regimen, cardiac safety was measured by rates of clinically symptomatic congestive heart failure, asymptomatic decrease in LVEF >10%, and decrease of LVEF below normal level. This was assessed up to 1 year following surgery. (NCT01855828)
Timeframe: Up to 1 year post surgery

InterventionParticipants (Count of Participants)
Chemo Plus Pertuzumab,Trastuzumab-symptomatic Congestive Heart0
Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF14
Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level1

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Pathological Response

Pathological response (pCR or microscopic only primary) in both primary and nodes using the Miller-Payne criteria for pathologic response. (NCT01869192)
Timeframe: Up to 8 months

InterventionParticipants (Count of Participants)
Arm A2
Arm B8

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Overall Response Rate

To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01869192)
Timeframe: Up to 8 months

InterventionParticipants (Count of Participants)
Arm A25
Arm B21

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IDFS Plus Second Primary Non-Breast Cancer

IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). (NCT01966471)
Timeframe: Baseline up to approximately 70 months

InterventionPercent Probability (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane93.43
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab92.26

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Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). (NCT01966471)
Timeframe: From randomization to approximately 7.5 years

InterventionPercentage of participants (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane98.5
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab99.1

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Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. (NCT01966471)
Timeframe: First participant randomized up to approximately 7.5 years

InterventionPercent Probability (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane96.03
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab94.86

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Invasive Disease-Free Survival (IDFS) in the Overall Population

IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization. (NCT01966471)
Timeframe: First participant randomized up to approximately 7.5 years

InterventionPercent Probability (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane94.22
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab93.06

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Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation

IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization. (NCT01966471)
Timeframe: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.

InterventionPercent Probability (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane94.10
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab92.75

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Disease-Free Survival (DFS)

DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS). (NCT01966471)
Timeframe: Baseline up to approximately 70 months

InterventionPercent Probability (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane93.32
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab92.04

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European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score

The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). (NCT01966471)
Timeframe: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18

InterventionUnits on a Scale (Mean)
Baseline: Appetite LossChange at Cycle 1: Appetite LossChange at Cycle 2: Appetite LossChange at Cycle 3: Appetite LossChange at Cycle 4: Appetite LossChange at Cycle 5: Appetite LossChange at Cycle 9: Appetite LossChange at Cycle 14: Appetite LossChange at EoT: Appetite LossChange at FU Month 6: Appetite LossChange at FU Month 12: Appetite LossChange at FU Month 18: Appetite LossBaseline: ConstipationChange at Cycle 1: ConstipationChange at Cycle 2: ConstipationChange at Cycle 3: ConstipationChange at Cycle 4: ConstipationChange at Cycle 5: ConstipationChange at Cycle 9: ConstipationChange at Cycle 14: ConstipationChange at EoT: ConstipationChange at FU Month 6: ConstipationChange at FU Month 12: ConstipationChange at FU Month 18: ConstipationBaseline: DiarrheaChange at Cycle 1: DiarrheaChange at Cycle 2: DiarrheaChange at Cycle 3: DiarrheaChange at Cycle 4: DiarrheaChange at Cycle 5: DiarrheaChange at Cycle 9: DiarrheaChange at Cycle 14: DiarrheaChange at EoT: DiarrheaChange at FU Month 6: DiarrheaChange at FU Month 12: DiarrheaChange at FU Month 18: DiarrheaBaseline: DyspneaChange at Cycle 1: DyspneaChange at Cycle 2: DyspneaChange at Cycle 3: DyspneaChange at Cycle 4: DyspneaChange at Cycle 5: DyspneaChange at Cycle 9: DyspneaChange at Cycle 14: DyspneaChange at EoT: DyspneaChange at FU Month 6: DyspneaChange at FU Month 12: DyspneaChange at FU Month 18: DyspneaBaseline: FatigueChange at Cycle 1: FatigueChange at Cycle 2: FatigueChange at Cycle 3: FatigueChange at Cycle 4: FatigueChange at Cycle 5: FatigueChange at Cycle 9: FatigueChange at Cycle 14: FatigueChange at EoT: FatigueChange at FU Month 6: FatigueChange at FU Month 12: FatigueChange at FU Month 18: FatigueBaseline: Financial DifficultiesChange at Cycle 1: Financial DifficultiesChange at Cycle 2: Financial DifficultiesChange at Cycle 3: Financial DifficultiesChange at Cycle 4: Financial DifficultiesChange at Cycle 5: Financial DifficultiesChange at Cycle 9: Financial DifficultiesChange at Cycle 14: Financial DifficultiesChange at EoT: Financial DifficultiesChange at FU Month 6: Financial DifficultiesChange at FU Month 12: Financial DifficultiesChange at FU Month 18: Financial DifficultiesBaseline: InsomniaChange at Cycle 1: InsomniaChange at Cycle 2: InsomniaChange at Cycle 3: InsomniaChange at Cycle 4: InsomniaChange at Cycle 5: InsomniaChange at Cycle 9: InsomniaChange at Cycle 14: InsomniaChange at EoT: InsomniaChange at FU Month 6: InsomniaChange at FU Month 12: InsomniaChange at FU Month 18: InsomniaBaseline: Nausea/VomitingChange at Cycle 1: Nausea/VomitingChange at Cycle 2: Nausea/VomitingChange at Cycle 3: Nausea/VomitingChange at Cycle 4: Nausea/VomitingChange at Cycle 5: Nausea/VomitingChange at Cycle 9: Nausea/VomitingChange at Cycle 14: Nausea/VomitingChange at EoT: Nausea/VomitingChange at FU Month 6: Nausea/VomitingChange at FU Month 12: Nausea/VomitingChange at FU Month 18: Nausea/VomitingBaseline: PainChange at Cycle 1: PainChange at Cycle 2: PainChange at Cycle 3: PainChange at Cycle 4: PainChange at Cycle 5: PainChange at Cycle 9: PainChange at Cycle 14: PainChange at EoT: PainChange at FU Month 6: PainChange at FU Month 12: PainChange at FU Month 18: PainBaseline: Cognitive FunctioningChange at Cycle 1: Cognitive FunctioningChange at Cycle 2: Cognitive FunctioningChange at Cycle 3: Cognitive FunctioningChange at Cycle 4: Cognitive FunctioningChange at Cycle 5: Cognitive FunctioningChange at Cycle 9: Cognitive FunctioningChange at Cycle 14: Cognitive FunctioningChange at EoT: Cognitive FunctioningChange at FU Month 6: Cognitive FunctioningChange at FU Month 12: Cognitive FunctioningChange at FU Month 18: Cognitive FunctioningBaseline: Emotional FunctioningChange at Cycle 1: Emotional FunctioningChange at Cycle 2: Emotional FunctioningChange at Cycle 3: Emotional FunctioningChange at Cycle 4: Emotional FunctioningChange at Cycle 5: Emotional FunctioningChange at Cycle 9: Emotional FunctioningChange at Cycle 14: Emotional FunctioningChange at EoT: Emotional FunctioningChange at FU Month 6: Emotional FunctioningChange at FU Month 12: Emotional FunctioningChange at FU Month 18: Emotional FunctioningBaseline: Physical FunctioningChange at Cycle 1: Physical FunctioningChange at Cycle 2: Physical FunctioningChange at Cycle 3: Physical FunctioningChange at Cycle 4: Physical FunctioningChange at Cycle 5: Physical FunctioningChange at Cycle 9: Physical FunctioningChange at Cycle 14: Physical FunctioningChange at EoT: Physical FunctioningChange at FU Month 6: Physical FunctioningChange at FU Month 12: Physical FunctioningChange at FU Month 18: Physical FunctioningBaseline: Role FunctioningChange at Cycle 1: Role FunctioningChange at Cycle 2: Role FunctioningChange at Cycle 3: Role FunctioningChange at Cycle 4: Role FunctioningChange at Cycle 5: Role FunctioningChange at Cycle 9: Role FunctioningChange at Cycle 14: Role FunctioningChange at EoT: Role FunctioningChange at FU Month 6: Role FunctioningChange at FU Month 12: Role FunctioningChange at FU Month 18: Role FunctioningBaseline: Social FunctioningChange at Cycle 1: Social FunctioningChange at Cycle 2: Social FunctioningChange at Cycle 3: Social FunctioningChange at Cycle 4: Social FunctioningChange at Cycle 5: Social FunctioningChange at Cycle 9: Social FunctioningChange at Cycle 14: Social FunctioningChange at EoT: Social FunctioningChange at FU Month 6: Social FunctioningChange at FU Month 12: Social FunctioningChange at FU Month 18: Social FunctioningBaseline: Global Health StatusChange at Cycle 1: Global Health StatusChange at Cycle 2: Global Health StatusChange at Cycle 3: Global Health StatusChange at Cycle 4: Global Health StatusChange at Cycle 5: Global Health StatusChange at Cycle 9: Global Health StatusChange at Cycle 14: Global Health StatusChange at EoT: Global Health StatusChange at FU Month 6: Global Health StatusChange at FU Month 12: Global Health StatusChange at FU Month 18: Global Health Status
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab7.610.813.110.39.49.08.26.45.6-2.4-2.3-16.79.08.00.90.2-0.6-0.43.34.24.71.52.00.04.74.216.011.310.38.84.75.13.0-1.10.0-16.76.29.27.46.55.95.67.58.18.85.35.8-16.720.614.411.28.78.28.49.810.69.33.11.8-5.619.90.3-0.6-0.4-0.20.7-0.5-1.0-1.7-5.2-6.80.024.91.80.4-0.11.11.11.12.70.9-2.3-2.9-16.72.310.57.55.23.73.22.83.01.70.10.6-8.316.41.12.82.53.13.83.95.75.11.40.5-25.088.7-6.9-6.8-6.4-6.9-7.3-7.6-8.1-8.4-6.1-6.016.775.70.01.62.22.82.62.92.53.16.16.512.589.1-5.9-4.8-4.1-3.5-3.5-3.8-4.2-4.9-1.6-0.813.383.4-5.7-5.5-2.7-3.2-3.5-3.2-4.3-3.52.43.78.383.2-5.3-4.1-3.3-3.2-2.6-3.4-2.4-1.64.06.433.373.9-7.2-7.1-5.2-5.5-5.8-6.4-6.3-4.90.31.216.7

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Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment

The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning. (NCT01966471)
Timeframe: From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.

,
Interventionmonths (Median)
GHS/QoL ScorePhysical FunctionRole FunctionCognitive Function
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab13.57NA9.929.46
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane2.7325.532.235.49

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Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time

LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans. (NCT01966471)
Timeframe: First participant randomized up to approximately 7.5 years.

,
InterventionParticipants (Count of Participants)
Decrease from baseline <10 Ejection Fraction (EF) pointsAbsolute value >= 50% and decrease from baseline >= 10 EF pointsAbsolute value < 50% and decrease from baseline >= 10 EF pointsAbsolute value < 50% and decrease from baseline >= 15 EF points
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab5222453528
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane5062547161

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European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score

The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). (NCT01966471)
Timeframe: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18

InterventionUnits on a Scale (Mean)
Baseline: Appetite LossChange at Cycle 1: Appetite LossChange at Cycle 2: Appetite LossChange at Cycle 3: Appetite LossChange at Cycle 4: Appetite LossChange at Cycle 5: Appetite LossChange at Cycle 9: Appetite LossChange at Cycle 14: Appetite LossChange at EoT: Appetite LossChange at FU Month 6: Appetite LossChange at FU Month 12: Appetite LossBaseline: ConstipationChange at Cycle 1: ConstipationChange at Cycle 2: ConstipationChange at Cycle 3: ConstipationChange at Cycle 4: ConstipationChange at Cycle 5: ConstipationChange at Cycle 9: ConstipationChange at Cycle 14: ConstipationChange at EoT: ConstipationChange at FU Month 6: ConstipationChange at FU Month 12: ConstipationBaseline: DiarrheaChange at Cycle 1: DiarrheaChange at Cycle 2: DiarrheaChange at Cycle 3: DiarrheaChange at Cycle 4: DiarrheaChange at Cycle 5: DiarrheaChange at Cycle 9: DiarrheaChange at Cycle 14: DiarrheaChange at EoT: DiarrheaChange at FU Month 6: DiarrheaChange at FU Month 12: DiarrheaBaseline: DyspneaChange at Cycle 1: DyspneaChange at Cycle 2: DyspneaChange at Cycle 3: DyspneaChange at Cycle 4: DyspneaChange at Cycle 5: DyspneaChange at Cycle 9: DyspneaChange at Cycle 14: DyspneaChange at EoT: DyspneaChange at FU Month 6: DyspneaChange at FU Month 12: DyspneaBaseline: FatigueChange at Cycle 1: FatigueChange at Cycle 2: FatigueChange at Cycle 3: FatigueChange at Cycle 4: FatigueChange at Cycle 5: FatigueChange at Cycle 9: FatigueChange at Cycle 14: FatigueChange at EoT: FatigueChange at FU Month 6: FatigueChange at FU Month 12: FatigueBaseline: Financial DifficultiesChange at Cycle 1: Financial DifficultiesChange at Cycle 2: Financial DifficultiesChange at Cycle 3: Financial DifficultiesChange at Cycle 4: Financial DifficultiesChange at Cycle 5: Financial DifficultiesChange at Cycle 9: Financial DifficultiesChange at Cycle 14: Financial DifficultiesChange at EoT: Financial DifficultiesChange at FU Month 6: Financial DifficultiesChange at FU Month 12: Financial DifficultiesBaseline: InsomniaChange at Cycle 1: InsomniaChange at Cycle 2: InsomniaChange at Cycle 3: InsomniaChange at Cycle 4: InsomniaChange at Cycle 5: InsomniaChange at Cycle 9: InsomniaChange at Cycle 14: InsomniaChange at EoT: InsomniaChange at FU Month 6: InsomniaChange at FU Month 12: InsomniaBaseline: Nausea/VomitingChange at Cycle 1: Nausea/VomitingChange at Cycle 2: Nausea/VomitingChange at Cycle 3: Nausea/VomitingChange at Cycle 4: Nausea/VomitingChange at Cycle 5: Nausea/VomitingChange at Cycle 9: Nausea/VomitingChange at Cycle 14: Nausea/VomitingChange at EoT: Nausea/VomitingChange at FU Month 6: Nausea/VomitingChange at FU Month 12: Nausea/VomitingBaseline: PainChange at Cycle 1: PainChange at Cycle 2: PainChange at Cycle 3: PainChange at Cycle 4: PainChange at Cycle 5: PainChange at Cycle 9: PainChange at Cycle 14: PainChange at EoT: PainChange at FU Month 6: PainChange at FU Month 12: PainBaseline: Cognitive FunctioningChange at Cycle 1: Cognitive FunctioningChange at Cycle 2: Cognitive FunctioningChange at Cycle 3: Cognitive FunctioningChange at Cycle 4: Cognitive FunctioningChange at Cycle 5: Cognitive FunctioningChange at Cycle 9: Cognitive FunctioningChange at Cycle 14: Cognitive FunctioningChange at EoT: Cognitive FunctioningChange at FU Month 6: Cognitive FunctioningChange at FU Month 12: Cognitive FunctioningBaseline: Emotional FunctioningChange at Cycle 1: Emotional FunctioningChange at Cycle 2: Emotional FunctioningChange at Cycle 3: Emotional FunctioningChange at Cycle 4: Emotional FunctioningChange at Cycle 5: Emotional FunctioningChange at Cycle 9: Emotional FunctioningChange at Cycle 14: Emotional FunctioningChange at EoT: Emotional FunctioningChange at FU Month 6: Emotional FunctioningChange at FU Month 12: Emotional FunctioningBaseline: Physical FunctioningChange at Cycle 1: Physical FunctioningChange at Cycle 2: Physical FunctioningChange at Cycle 3: Physical FunctioningChange at Cycle 4: Physical FunctioningChange at Cycle 5: Physical FunctioningChange at Cycle 9: Physical FunctioningChange at Cycle 14: Physical FunctioningChange at EoT: Physical FunctioningChange at FU Month 6: Physical FunctioningChange at FU Month 12: Physical FunctioningBaseline: Role FunctioningChange at Cycle 1: Role FunctioningChange at Cycle 2: Role FunctioningChange at Cycle 3: Role FunctioningChange at Cycle 4: Role FunctioningChange at Cycle 5: Role FunctioningChange at Cycle 9: Role FunctioningChange at Cycle 14: Role FunctioningChange at EoT: Role FunctioningChange at FU Month 6: Role FunctioningChange at FU Month 12: Role FunctioningBaseline: Social FunctioningChange at Cycle 1: Social FunctioningChange at Cycle 2: Social FunctioningChange at Cycle 3: Social FunctioningChange at Cycle 4: Social FunctioningChange at Cycle 5: Social FunctioningChange at Cycle 9: Social FunctioningChange at Cycle 14: Social FunctioningChange at EoT: Social FunctioningChange at FU Month 6: Social FunctioningChange at FU Month 12: Social FunctioningBaseline: Global Health StatusChange at Cycle 1: Global Health StatusChange at Cycle 2: Global Health StatusChange at Cycle 3: Global Health StatusChange at Cycle 4: Global Health StatusChange at Cycle 5: Global Health StatusChange at Cycle 9: Global Health StatusChange at Cycle 14: Global Health StatusChange at EoT: Global Health StatusChange at FU Month 6: Global Health StatusChange at FU Month 12: Global Health Status
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane8.212.215.214.316.212.05.72.20.5-1.3-2.29.68.41.12.02.50.5-0.70.60.23.42.85.24.732.528.426.523.912.612.510.3-0.3-0.35.810.411.613.414.313.77.86.87.67.06.221.513.215.415.316.014.98.46.75.52.81.920.12.22.03.93.73.40.9-1.4-1.1-3.8-5.123.93.66.06.28.65.24.32.72.50.90.02.610.46.05.04.74.01.11.10.90.20.517.41.85.03.55.45.23.42.01.90.80.088.6-9.7-9.4-10.1-11.8-10.8-8.3-8.1-8.7-8.0-7.176.0-1.1-1.0-0.9-2.5-1.23.14.13.04.75.888.4-6.0-7.8-7.1-8.4-8.3-4.0-2.7-2.2-0.6-0.183.1-5.1-9.7-8.9-10.7-9.4-3.3-0.5-0.22.22.683.0-8.0-10.1-9.5-10.3-8.7-1.7-0.10.33.34.674.3-7.5-12.4-11.7-12.7-12.1-5.9-3.9-3.5-0.6-0.2

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EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement. (NCT01966471)
Timeframe: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18

,
InterventionUnits on a Scale (Mean)
Baseline: Arm SymptomsChange at Cycle 1: Arm SymptomsChange at Cycle 2: Arm SymptomsChange at Cycle 3: Arm SymptomsChange at Cycle 4: Arm SymptomsChange at Cycle 5: Arm SymptomsChange at Cycle 9: Arm SymptomsChange at Cycle 14: Arm SymptomsChange at EoT: Arm SymptomsChange at FU Month 6: Arm SymptomsChange at FU Month 12: Arm SymptomsBaseline: Breast SymptomsChange at Cycle 1: Breast SymptomsChange at Cycle 2: Breast SymptomsChange at Cycle 3: Breast SymptomsChange at Cycle 4: Breast SymptomsChange at Cycle 5: Breast SymptomsChange at Cycle 9: Breast SymptomsChange at Cycle 14: Breast SymptomsChange at EoT: Breast SymptomsChange at FU Month 6: Breast SymptomsChange at FU Month 12: Breast SymptomsBaseline: Systemic Therapy Side Effects (SE)Change at Cycle 1: Systemic Therapy SEChange at Cycle 2: Systemic Therapy SEChange at Cycle 3: Systemic Therapy SEChange at Cycle 4: Systemic Therapy SEChange at Cycle 5: Systemic Therapy SEChange at Cycle 9: Systemic Therapy SEChange at Cycle 14: Systemic Therapy SEChange at EoT: Systemic Therapy SEChange at FU Month 6: Systemic Therapy SEChange at FU Month 12: Systemic Therapy SEBaseline: Upset by Hair Loss ItemChange at Cycle 1: Upset by Hair Loss ItemChange at Cycle 2: Upset by Hair Loss ItemChange at Cycle 3: Upset by Hair Loss ItemChange at Cycle 4: Upset by Hair Loss ItemChange at Cycle 5: Upset by Hair Loss ItemChange at Cycle 9: Upset by Hair Loss ItemChange at Cycle 14: Upset by Hair Loss ItemChange at EoT: Upset by Hair Loss ItemChange at FU Month 6: Upset by Hair Loss ItemChange at FU Month 12: Upset by Hair Loss ItemBaseline: Body ImageChange at Cycle 1: Body ImageChange at Cycle 2: Body ImageChange at Cycle 3: Body ImageChange at Cycle 4: Body ImageChange at Cycle 5: Body ImageChange at Cycle 9: Body ImageChange at Cycle 14: Body ImageChange at EoT: Body ImageChange at FU Month 6: Body ImageChange at FU Month 12: Body ImageBaseline: Future Perspectives (FP)Change at Cycle 1: FPChange at Cycle 2: FPChange at Cycle 3: FPChange at Cycle 4: FPChange at Cycle 5: FPChange at Cycle 9: FPChange at Cycle 14: FPChange at EoT: FPChange at FU Month 6: FPChange at FU Month 12: FPBaseline: Sexual EnjoymentChange at Cycle 1: Sexual EnjoymentChange at Cycle 2: Sexual EnjoymentChange at Cycle 3: Sexual EnjoymentChange at Cycle 4: Sexual EnjoymentChange at Cycle 5: Sexual EnjoymentChange at Cycle 9: Sexual EnjoymentChange at Cycle 14: Sexual EnjoymentChange at EoT: Sexual EnjoymentChange at FU Month 6: Sexual EnjoymentChange at FU Month 12: Sexual EnjoymentBaseline: Sexual FunctionChange at Cycle 1: Sexual FunctionChange at Cycle 2: Sexual FunctionChange at Cycle 3: Sexual FunctionChange at Cycle 4: Sexual FunctionChange at Cycle 5: Sexual FunctionChange at Cycle 9: Sexual FunctionChange at Cycle 14: Sexual FunctionChange at EoT: Sexual FunctionChange at FU Month 6: Sexual FunctionChange at FU Month 12: Sexual Function
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab19.5-3.1-3.0-3.5-2.9-2.6-1.11.30.4-1.3-2.816.8-2.5-2.9-3.1-3.3-2.60.30.50.3-1.5-3.78.723.318.315.113.211.810.49.88.54.24.214.225.221.821.419.710.06.02.50.0-3.5-2.878.9-13.3-10.1-6.6-5.9-5.0-4.2-2.4-2.90.30.749.8-0.33.76.57.89.78.47.97.612.613.146.7-8.2-10.7-8.9-9.2-8.8-7.4-9.7-9.7-3.0-2.318.3-3.5-4.4-3.3-3.4-3.0-1.8-2.8-1.70.60.9
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane19.9-1.3-2.8-3.5-2.0-0.5-0.20.30.1-0.1-0.817.5-2.3-3.3-4.0-3.9-3.11.7-0.2-1.0-2.5-4.28.524.924.123.423.120.09.57.57.25.85.413.235.128.728.828.426.411.89.317.36.22.478.5-13.7-12.7-11.5-11.4-10.5-5.9-4.5-3.3-1.30.049.3-1.31.43.24.25.98.29.58.510.515.043.4-5.9-9.5-11.4-11.9-14.2-9.4-3.9-6.5-4.6-5.716.7-2.3-4.8-5.6-6.8-5.9-3.4-1.8-1.51.60.9

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Distant Recurrence-Free Interval (DRFI)

DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence. (NCT01966471)
Timeframe: Baseline up to approximately 70 months

InterventionPercent Probability (Number)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane95.23
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab94.91

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Pathologic Response Rate, Defined as the Percentage of Participants With Greater Than or Equal to 95% Necrosis.

Descriptive statistical analysis will be conducted. The proportion with 95% confidence interval will be summarized. (NCT02050919)
Timeframe: Assessed at surgical resection

Intervention% of participants (Number)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)20

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Overall Survival at 2 Years

Percentage of patients alive at 2 years, Method of Kaplan-Meier used. (NCT02050919)
Timeframe: Time from registration until death from any cause

Interventionpercentage of patients (Number)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)82

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Number of Participants With Wound Complications

Wound complication rate, including 1) any secondary operation for wound repair, or 2) wound management without secondary operation including invasive procedures without general or regional anesthesia, readmission for wound care, or persistent deep packing for 120 days or longer. (NCT02050919)
Timeframe: At least 120 days

InterventionParticipants (Count of Participants)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)10

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Number of Grade 3-4 Adverse Events

Measured as the number of Grade 3-4 Adverse Events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (NCT02050919)
Timeframe: Up to 5 years

InterventionGrade 3-4 Adverse Events (Number)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)86

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Overall Disease-free Survival (Stage IIB-III Patients)

Time from surgical resection to local recurrence, distant metastatic disease or death, subjects with stage IV disease excluded. Method of Kaplan-Meier used. (NCT02050919)
Timeframe: Time from surgical resection to local recurrence, distant metastatic disease, or death, whichever occurs first, assessed up to 2 years

InterventionMonths (Median)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)13.3

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Distant Disease-free Survival (Stage IIB-III Patients)

Time from registration to development of distant metastatic disease or death, subjects with stage IV disease excluded. Method of Kaplan-Meier used. (NCT02050919)
Timeframe: Time from registration until development of distant metastatic disease or death, whichever occurs first, assessed up to 2 years

InterventionMonths (Median)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)16.4

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Number of Participants With Local Recurrence

Number of patients with local recurrence after surgical resection of the primary tumor (NCT02050919)
Timeframe: Time from surgical resection until primary analysis ( Median follow-up for local recurrence 17.11 months, range 6.18 - 42.8 months)

InterventionParticipants (Count of Participants)
Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)0

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Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery

Total pathologic complete response (tpCR) was the pCR based on tumor and nodal staging (i.e., histological confirmation of pCR in breast and nodes at surgery) and was defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes (i.e., ypT0/is ypN0 tpCR). Participants who did not undergo surgery or did not have a valid pCR assessment were considered non-responders in the analysis. The 95% CIs were calculated using the Clopper-Pearson method. (NCT02132949)
Timeframe: After completion of neoadjuvant treatment and surgery (up to 25 weeks)

InterventionPercentage of participants (Number)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab61.8
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab60.7

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Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period

"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms severe and serious are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs." (NCT02132949)
Timeframe: From first dose of any study drug prior to surgery through the day before the first dose of study drug after surgery (up to 25 weeks)

,
InterventionParticipants (Count of Participants)
Any Adverse Event (AE)NCI-CTCAE Grade 3-5 AESerious AEDeathsEjection Fraction Decreased (Any Grade)Heart Failure (Any Grade)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab19899450144
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab19810852070

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Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period

"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms severe and serious are not synonymous with respect to an AE. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness needed to be independently assessed for each AE that was recorded. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as an AE with the term of ejection fraction decreased). In the results table, multiple occurrences of the same AE in one individual were counted only once. Any AE includes all serious and non-serious AEs." (NCT02132949)
Timeframe: From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)

,
InterventionParticipants (Count of Participants)
Any Adverse Event (AE)NCI-CTCAE Grade 3-5 AESerious AEDeathsEjection Fraction Decreased (Any Grade)Heart Failure (Any Grade)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab17123150150
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab17140170202

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Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years

The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Overall survival (OS) was defined as the time from enrollment to death from any cause. Participants who were alive or lost to follow-up were censored at their last known date in the study. Participants with no post-baseline assessments were censored at the date of enrollment plus 1 day. (NCT02132949)
Timeframe: At 1, 2, 3, 4, and 5 years

,
InterventionEstimate of percentage of participants (Number)
1 Year2 Years3 Years4 Years5 Years
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab99.4898.9697.8697.8696.10
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab100.0097.9496.3894.8193.75

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Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1

The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Invasive disease-free survival (iDFS) was defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be alive and disease-free. Participants with no postbaseline information and participants who did not undergo surgery were excluded from the analysis. (NCT02132949)
Timeframe: At 1, 2, 3, and 4 years

,
InterventionEstimate of percentage of participants (Number)
1 Year2 Years3 Years4 Years
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab98.9195.5794.4292.60
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab96.3494.2591.0691.06

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Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1

The Kaplan-Meier method was used to estimate the percentage of participants who were event-free at landmark timepoints. Event-free survival (EFS) was defined as the time from enrollment to the first occurrence of progressive disease (PD), relapse, or death from any cause, with tumor evaluations performed by the investigator according to RECIST v1.1. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) were not counted as progressive disease or relapse. Participants who withdrew from the study without documented progression or relapse and for whom there existed evidence that evaluations had been made, were censored at the date of the last assessment at which the participant was known to be free from progressive disease or relapse. Participants with no tumor evaluations after baseline were censored at the date of enrollment plus 1 day. (NCT02132949)
Timeframe: At 1, 2, 3, 4, and 5 years

,
InterventionEstimate of percentage of participants (Number)
1 Year2 Years3 Years4 Years5 Years
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab98.4795.8093.5892.3990.84
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab97.4892.8690.7889.7389.20

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Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period

LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. (NCT02132949)
Timeframe: From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years)

,
InterventionPercentage of participants (Number)
At Least One LVEF Significant Decline Event (Confirmed+Single)At Least One Confirmed LVEF Significant DeclineAt Least One Single LVEF Significant Decline
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab6.03.03.0
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab3.51.02.5

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Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period

The clinical response rate was defined as the percentage of participants in the ITT population who achieved a complete response (CR) or partial response (PR) prior to surgery, according to RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. Participants were classified as missing or unevaluable if no assessments were measured prior to surgery on the ipsilateral breast. The 95% CIs were calculated using the Clopper-Pearson method; they were only calculated for responses (not for missing or unevaluable data). (NCT02132949)
Timeframe: From Baseline until disease progression or death due to any cause up to 24 weeks (during the neoadjuvant treatment period; assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])

,
InterventionPercentage of participants (Number)
Clinical Response Rate (CR+PR)Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Missing or Unevaluable
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab67.339.727.67.00.525.1
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab60.223.936.310.01.028.9

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Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period

Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. (NCT02132949)
Timeframe: From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)

InterventionPercentage of participants (Number)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab0
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab0.5

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Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period

Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later. (NCT02132949)
Timeframe: From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)

Interventionpercentage of participants (Number)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab1.5
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab0

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Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period

Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. (NCT02132949)
Timeframe: From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years)

InterventionPercentage of participants (Number)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab0
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab0.5

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Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period

"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms severe and serious are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once." (NCT02132949)
Timeframe: From 42 days after the last dose of study treatment until the end of treatment-free follow-up (TFFU; up to 5 years)

,
InterventionParticipants (Count of Participants)
Any Adverse Event (AE)NCI-CTCAE Grade 3-5 AESerious AEDeathsEjection Fraction Decreased (Any Grade)Heart Failure (Any Grade)
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab323710
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab7571311

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Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline

ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample. (NCT02132949)
Timeframe: Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months)

,
InterventionPercentage of participants (Number)
At BaselineAnytime Post-Baseline
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab1.64.6
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab2.13.6

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Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period

LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals were calculated using the Clopper-Pearson method. Results included events with onset from the first dose of any study drug after surgery through 42 days after the last dose of any study drug. (NCT02132949)
Timeframe: From the first dose of any study drug after surgery through 42 days after the last dose of any study drug (during the adjuvant treatment period; up to approximately 39 weeks)

,
Interventionpercentage of participants (Number)
At Least One LVEF Significant Decline Event (Confirmed+Single)At Least One Confirmed LVEF Significant DeclineAt Least One Single LVEF Significant Decline
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab7.72.85.0
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab10.53.27.4

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Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period

LVEF significant decline was defined as the decline in LVEF of >/= 10%-points from baseline to an LVEF of < 50%. A Confirmed LVEF Significant Decline was defined as at least two consecutive readings of significant declines in LVEF. A Single LVEF Significant Decline was defined as only one reading of a significant decline (no consecutive readings) in LVEF. The category of 'At Least one LVEF Significant Decline Event' was defined as the total of confirmed and single LVEF significant declines. The 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Results include events with onset from the first dose of pertuzumab or trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab or trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever is later. (NCT02132949)
Timeframe: From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)

,
Interventionpercentage of participants (Number)
At Least One LVEF Significant Decline Event (Confirmed+Single)At Least One Confirmed LVEF Significant DeclineAt Least One Single LVEF Significant Decline
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab6.51.05.5
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab2.00.51.5

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Rate of Pathologic Complete Response (pCR) Based on Response Evaluation Criteria in Solid Tumors Criteria

The pCR rate will first be determined as proportions and calculating its 95% confidence interval. To study the association between pCR response (yes/no) and the presence of gross residual disease, type and number of mutations, clinical lymph node status (positive/negative), tumor size (< 2 cm/>= 2 cm) based on p53, logistic regression analysis will be used, controlling for cancer treatment and disease stage and other covariates if numbers allow. (NCT02315196)
Timeframe: Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).

InterventionParticipants (Count of Participants)
Treatment (Doxil, Carboplatin, Surgery, Paclitaxel)16

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The Number of Patients With Tumor Size Reduction (Objective Response Rate)

Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT02358863)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Chemotherapy0

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Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months

"Kaplan-Meier analyses the percent of participants for TTP which is defined as the length of time from the treatment initiation to either the date of the first disease progression occurred, as assessed by the investigators, or the date of the subject died due to any cause, whichever comes earlier. EASL and mRECIST response assessment of target lesion for HCC. TTP (also referred as time to treatment failure) will be measured by a few data items list below:~The date of the disease progression in the Overall Response form~The date of lost-to-follow due to:~Adverse events~Progressive disease/insufficient therapeutic response~Death~Failure to return~Refusing treatment/being unwilling to cooperate/withdrawing consent~The very last date by scanning all available dates in the database~The desired cut-off days" (NCT03113955)
Timeframe: At 12 months

InterventionPercent of participants (Number)
EASLmRECIST
Single -Arm108

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Number of Adverse Events Relate to Study Device in 12 Months Post Procedure

Number and documents of adverse events relate to study device in 12 months post procedure (NCT03113955)
Timeframe: in 12 months

Interventionadverse events (Number)
SAEs of related with TANDEM MicrospheresNon-serious AEs of related with TANDEM Microspheresrate
Single -Arm17301

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Number of Participants With Objective Tumor Response at 3 Months

"The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.~Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.~Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart." (NCT03113955)
Timeframe: At 3 months

InterventionParticipants (Count of Participants)
EASL ResponsemRECIST Response
Single -Arm8485

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Number of Participants With Objective Tumor Response at 30-day

"The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.~Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.~Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart." (NCT03113955)
Timeframe: At 1month

InterventionParticipants (Count of Participants)
EASL ResponsemRECIST Response
Single -Arm8686

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Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread

"Kaplan-Meier analyses the percent of participants for Time to Extrahepatic Spread which the length of time from the treatment initiation to the development of extrahepatic spread of the disease via imaging assessment.~The data items to be considered will include:~The date of the extrahepatic spread in the Overall Response form~The very last date by scanning all available dates in the database~The desired cut-off days" (NCT03113955)
Timeframe: At 12 month

InterventionPercent of participants (Number)
Single -Arm20

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Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months

"Kaplan-Meier analyses the percent of participants for PPF which is defined as the length of time from the treatment initiation, that treated subjects are still progression-free. EASL and mRECIST response assessment of target lesion for HCC.~The data items to be captured will include:~The date of the disease progression in the Overall Response form~The very last date by scanning all available dates in the database~The desired cut-off days The proportion of any time point will be determined by the Kaplan-Meier estimates." (NCT03113955)
Timeframe: from first TACE to 12 months

InterventionPercent of participants (Number)
EASLmRECIST
Single -Arm108

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Kaplan-Meier Analyses the Percent of Participants for Overall Survival

"Kaplan-Meier analyses the percent of participants for Overall survival which is defined as the length of time from the treatment initiation, that treated subjects are still alive. The Kaplan-Meier analysis is aimed to capture the all-cause death for each subject. Subjects who are lost-to-follow will be considered being censored.~There are three critical data items to be captured:~Death date~The very last date in the database (e.g. follow-up visit date and/or site reported AE date)~The desired cut-off days (e.g. 6-month OS at 182 days, 12-month OS at 365 days) In addition to the Kaplan-Meier survival curve, the median survival time (mOS) will also be used to represent the study cohort." (NCT03113955)
Timeframe: from first TACE to 12 months

InterventionPercent of participants (Number)
Single -Arm100

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Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)

"The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.~Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.~Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart." (NCT03113955)
Timeframe: At 6 months

Interventionparticipants (Number)
6-month ORR (EASL criteria)6-month ORR (mRECIST criteria)
Single -Arm7573

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Objective Response Rate (ORR)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR. (NCT03556358)
Timeframe: End of Treatment (Week 24) or Early Termination Visit

InterventionParticipants (Count of Participants)
TX05 (Trastuzumab)332
Herceptin®340

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Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)

Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0). (NCT03556358)
Timeframe: 3-7 weeks following last dose of study treatment

,
Interventionparticipants (Number)
Subjects who do not Meet pCR CriteriaSubjects Meeting pCR Criteria
Herceptin®185153
TX05 (Trastuzumab)172164

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