anastrozole profile

ID Source	ID
PubMed CID	2187
CHEMBL ID	1399
CHEBI ID	2704
SCHEMBL ID	9726
MeSH ID	M0238999

Synonym
AC-4234
HY-14274
HMS3394M11
AB00639929-10
AB00639929-08
AB00639929-09
zd1033
arimidex (astrazeneca)
.alpha.,.alpha.',.alpha.'-tetramethyl-5(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile
ici-d1033
2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)benzene-1,3-diyl]bis(2-methylpropanenitrile)
anastrazole
zd-1033
arimidex
2,2'-(5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene)bis(2-methylpropionitrile)
1,3-benzenediacetonitrile, alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-
alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile
zd 1033
hsdb 7462
ici-d 1033
MLS001424217
C08159
120511-73-1
anastrozole ,
MLS000759396
smr000466301
anastrozol
2-[3-(1-cyano-1-methylethyl)-5-(1h-1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile
bdbm10015
chembl1399 ,
DB01217
2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methyl-propanenitrile
nsc719344
nsc-719344
1,.alpha.,alpha.,alpha.',.alpha.'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-
ici d1033
D00960
anastrozole (jan/usp/inn)
arimidex (tn)
NCGC00164619-01
HMS2089N10
HMS2052M11
CHEBI:2704 ,
2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene]bis(2-methylpropanenitrile)
nsc-759855
rvg-106400
2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropanenitrile
A804526
2,2'-(5-((1h-1,2,4-triazol-1-yl)methyl)-1,3-phenylene)bis(2-methylpropanenitrile)
alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile
dtxcid202607
dtxsid9022607 ,
cas-120511-73-1
NCGC00257356-01
tox21_303568
tox21_112238
BCP9000301
pharmakon1600-01502278
nsc759855
HMS2235M06
CCG-101109
anastrozole [usan:usp:inn:ban]
asiolex
unii-2z07myw1az
nsc 719344
nsc 759855
2z07myw1az ,
ccris 9352
BCPP000401
NCGC00164619-04
anastrozole [inn]
anastrozole [ep monograph]
anastrozole [who-dd]
anastrozole [usp monograph]
anastrozole [usp-rs]
anastrozole [mart.]
anastrozole [orange book]
1,3-benzenediacetonitrile,.alpha.,.alpha.,.alpha.',.alpha.'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-
.alpha.,.alpha.,.alpha.',.alpha.'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile
anastrozole [usan]
anastrozole [mi]
anastrozole [usp impurity]
anastrozole [hsdb]
anastrozole [jan]
CS-0716
S1188
AKOS015894980
gtpl5137
HMS3369K05
AB00639929-06
NC00359
SCHEMBL9726
NCGC00164619-02
tox21_112238_1
KS-5052
2,2'-[5-(1h-1,2,4-triazol-1-yl-methyl)-1,3-phenylene]-di(2-methyl propionitrile)
2,2'-[5-(1h-1,2,4-triazole-1-yl-methyl)-1,3-phenylene]di(2-methyl propionitrile)
2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene]di(2-methylpropiononitrile)
MLS006011961
?1,?1,?3,?3-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile
AB00639929_13
AB00639929_11
STL451008
alpha1,alpha1,alpha3,alpha3-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile
mfcd00866298
sr-01000759390
SR-01000759390-5
SR-01000759390-4
HMS3654I18
anastrozole; 2,2'-[5-(1h-1,2,4-triazol-1-ylmethyl)benzene-1,3-diyl]bis(2-methylpropanenitrile)
HMS3715B05
SW197739-4
Q419143
Z1515385077
BCP02090
3-amino-3-(4-diethylamino-2-hydroxy-phenyl)-propionicacid
SB17304
HMS3866K03
AMY42020
HMS3742O21
2-[3-(2-cyano-2-propyl)-5-(1,2,4-triazol-1-ylmethyl)phenyl]-2-methylpropiononitrile
2-[3-(1-cyano-1-methylethyl)-5-[(1h-1,2,4-triazol-1-yl)methyl]phenyl]-2-methylpropanenitrile
EN300-118709
BT164176
anastrozole- bio-x
l02bg03
2,2'-(5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene)bis(2-methylpropanenitrile)
alpha, alpha, alpha', alpha'-tetramethylyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile
anastrozolum
ici-d-1033
anastrozole (usp monograph)
1,3-benzenediacetonitrile,alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-
2-(3-(1-cyano-1-methylethyl)-5-(1h-1,2,4-triazol-1-ylmethyl)phenyl)-2-methylpropanenitrile
anastrozole (mart.)
anastrozole (usan:usp:inn:ban)
anastrozole (usp-rs)
alpha,alpha,alpha', alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile
2,2'-(5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene)di(2-methylpropionitrile)
anastrozole tablets
anastrozole (ep monograph)
anastrozole (usp impurity)

Excerpt	Reference	Relevance
"Anastrozole (ATZ) is a selective non-steroidal inhibitor widely used for the treatment of breast cancer in post-menopausal women. "	( Simultaneous Method Development and Validation of Anastrozole Along with Piperine: Degradation Studies and Degradants Characterization Using LC-QTOF-ESI-MS Along with In-silico ADMET Predictions. Alexander, A; Gajbhiye, R; Kumar, P; Mehta, P; Murty, US; Pawar, SD; Ravichandiran, V; Sarmah, B; Susanna, KJ, 2022)	2.42
"Anastrozole (ANA), is an inhibitor of non-steroidal aromatase, widely employed for the treatment of breast cancer. "	( Anastrozole and related glucuronic acid conjugate are electrophilic species. Chen, Y; Ding, S; Liu, S; Peng, Y; Zheng, J, 2022)	3.61
"Anastrozole is an infertility inhibitor of aromatase."	( The effect of aromatase inhibitors against possible testis toxicity in pembrolizumab treated rats. Aydın, M; Çiftçi, O; Eke, BC; Taşlıdere, A; Türkmen, NB, 2022)	1.44
"Anastrozole is an aromatase inhibitor that has been used more frequently over the last decade especially for oestrogen receptor-positive breast cancer. "	( Anastrozole-induced liver injury after a prolonged latency: a very rare complication of a commonly prescribed medication. Abdallah, M; Abdullah, HMA; Niazi, M; Quist, E; Xie, C, 2019)	3.4
"Anastrozole (ANZ) is a breast cancer drug that was introduced onto the pharmaceutical market in the 1990s and is still one of the most widely consumed cytotoxic compounds. "	( Solar photo-Fenton treatment of the anti-cancer drug anastrozole in different aqueous matrices at near-neutral pH: Transformation products identification, pathways proposal, and in silico (Q)SAR risk assessment. Lüdtke, DS; Sanabria, P; Scunderlick, D; Sirtori, C; Wilde, ML, 2021)	2.31
"Anastrozole is a nonsteroidal compound and a potent selective inhibitor of the aromatase enzyme."	( Use of anastrozole in the chemoprevention and treatment of breast cancer: A literature review. Andrade, DB; Barros-Oliveira, MDC; Borges, RS; Borges, US; Costa-Silva, DR; Silva, BBD; Silva, JM; Tavares, CB, 2017)	1.63
"Anastrozole (ANS) is an aromatase inhibitor that is widely used as a treatment for breast cancer in postmenopausal women. "	( Preparation of anastrozole loaded PEG-PLA nanoparticles: evaluation of apoptotic response of breast cancer cell lines. Alaamery, M; Alghamdi, B; Almutairi, MS; Alomran, N; Alyafee, YA; Bawazeer, S; Daghestani, M; Massadeh, S; Sheereen, A, 2018)	2.28
"Anastrozole is a well-established active pharmaceutical ingredient (API) used for the treatment of hormone-sensitive breast cancer (BC) in postmenopausal women. "	( Pharmacokinetic evaluation of a transdermal anastrozole-in-adhesive formulation. Abraham, G; Aigner, A; Baumann, F; Brätter, C; Regenthal, R; Teichert, J; Voskanian, M, 2018)	2.18
"Anastrozole is a widely prescribed aromatase inhibitor for the therapy of estrogen receptor positive (ER+) breast cancer. "	( Anastrozole Aromatase Inhibitor Plasma Drug Concentration Genome-Wide Association Study: Functional Epistatic Interaction Between SLC38A7 and ALPPL2. Barman, P; Batzler, A; Buzdar, AU; Cairns, J; Carlson, EE; Desta, Z; Devarajan, S; Dudenkov, TM; Goetz, MP; Ingle, JN; Jenkins, GD; Kalari, KR; Kubo, M; Liu, D; Moreno-Aspitia, A; Northfelt, DW; Reid, JM; Robson, ME; Wang, L; Weinshilboum, RM; Zhuang, Y, 2019)	3.4
"Anastrozole (AZ) is an aromatase inhibitor that has been used off-label for the treatment of male hypogonadism."	( Coadministration of anastrozole sustains therapeutic testosterone levels in hypogonadal men undergoing testosterone pellet insertion. Frankel, J; McCullough, A; Mechlin, CW, 2014)	1.45
"Anastrozole is an effective superovulator, but has not been well researched."	( Anastrozole is a dose-specific superovulator and favors implantation in rats: a prospective study. Hosie, MJ; Mwakikunga, A, 2016)	2.6
"Anastrozole is a selective aromatase inhibitor and is used for the hormonal treatment of postmenopausal breast cancer. "	( Anastrozole-associated sclerosing glomerulonephritis in a patient with breast cancer. Akgul, B; Camci, C; Kalender, ME; Karakok, M; Sevinc, A; Turk, HM, 2007)	3.23
"Anastrozole (Arimidex) is an aromatase inhibitor approved in the EU, the US and in other countries worldwide for use as an adjuvant treatment in postmenopausal women with early-stage, hormone receptor-positive breast cancer. "	( Anastrozole: a review of its use in postmenopausal women with early-stage breast cancer. Plosker, GL; Sanford, M, 2008)	3.23
"Anastrozole therapy is a useful treatment for postmenopausal woman with ER-positive recurrent breast cancer."	( [A case of recurrent breast cancer with multiple lung metastases responding to anastrozole monotherapy]. Hashida, S; Hirano, Y; Iga, K; Inukai, M; Ito, M; Kanaya, Y; Maruyama, S; Shimo, T; Yokoyama, N, 2008)	1.29
"Anastrozole (Arimidex) is a potent and selective reversible inhibitor of the aromatase enzyme in females."	( Pharmacokinetics and pharmacodynamics of anastrozole in pubertal boys with recent-onset gynecomastia. Agbo, F; Bishop, K; Emeribe, U; Lowe, E; Mauras, N; Merinbaum, D, 2009)	1.34
"Anastrozole is a potent aromatase inhibitor in adolescent males, with rapid absorption and slow elimination kinetics after oral dosing. "	( Pharmacokinetics and pharmacodynamics of anastrozole in pubertal boys with recent-onset gynecomastia. Agbo, F; Bishop, K; Emeribe, U; Lowe, E; Mauras, N; Merinbaum, D, 2009)	2.06
"Anastrozole is a safe and tolerable drug especially used to suppress estrogen action."	( Treatment of autonomous ovarian follicular cyst with long-term anastrozole therapy. Berberoglu, M; Bilir, P; Engiz, O; Ocal, G; Siklar, Z, 2009)	1.31
"Anastrozole is a potent aromatase inhibitor and there is a need for an alternative to the oral method of administration to target cancer tissues. "	( Transdermal patches for site-specific delivery of anastrozole: In vitro and local tissue disposition evaluation. Fang, L; He, Z; Liu, J; Mu, L; Sun, L; Xi, H; Yang, Y; Zhao, D; Zhao, N; Zhao, Y; Zheng, N, 2010)	2.06
"Anastrozole is a third-generation aromatase inhibitor used in the adjuvant setting for the treatment of hormone receptor-positive breast cancer. "	( Anastrozole. Buzdar, AU; Kelly, CM, 2010)	3.25
"Anastrozole is an aromatase inhibitor used to treat advanced breast cancer in postmenopausal women. "	( Pharmacokinetic comparison of 2 formulations of anastrozole (1 mg) in healthy Korean male volunteers: a randomized, single-dose, 2-period, 2-sequence, crossover study. Bae, KS; Cho, SH; Choe, S; Ghim, JL; Jin, SJ; Jung, JA; Kim, UJ; Ko, YJ; Lim, HS; Noh, YH; Park, HJ; Song, GS, 2012)	2.08
"Anastrozole is a selective aromatase inhibitor as it does not modify serum levels of androgens and 17OH-PGR. "	( Biological activity of anastrozole in postmenopausal patients with advanced breast cancer: effects on estrogens and bone metabolism. Bajetta, E; Bombardieri, E; Ferrari, L; La Torre, I; Longarini, R; Martinetti, A; Pozzi, P; Salvucci, G; Seregni, E; Zilembo, N, 2002)	2.07
"Anastrozole is an orally active, non-steroidal aromatase inhibitor which appears effective as neoadjuvant treatment of breast cancer. "	( Effect of neoadjuvant treatment with anastrozole on tumour histology in postmenopausal women with large operable breast cancer. Anderson, TJ; Dixon, JM; Miller, WR; Sahmoud, T; Stuart, M, 2002)	2.03
"Anastrozole therapy is a useful treatment for postmenopausal women with ER positive advanced breast cancer."	( [Advanced breast cancer with lung and pleural metastases responsive to anastrozole--a case report]. Enomoto, K; Kinoshita, T; Nishimura, M; Okamura, Y; Oura, S; Sakurai, T; Yokochi, H, 2002)	1.27
"Anastrozole is a third-generation non-steroidal aromatase inhibitor."	( Focus on anastrozole and breast cancer. Mokbel, K, 2003)	1.46
"Anastrozole appears to be an interesting new modality for the treatment of endometrial hyperplasia in obese postmenopausal women."	( Aromatase inhibitor anastrozole for treating endometrial hyperplasia in obese postmenopausal women. Agorastos, T; Bontis, JN; Efstathiadis, E; Pantazis, K; Vaitsi, V; Vavilis, D, 2005)	1.37
"Anastrozole is an oral aromatase inhibitor that normalizes serum testosterone levels and decreases oestradiol levels modestly in elderly men with mild hypogonadism. "	( Effect of aromatase inhibition on lipids and inflammatory markers of cardiovascular disease in elderly men with low testosterone levels. Dougherty, RH; Hayden, D; Leder, BZ; Rohrer, JL; Rubin, SD, 2005)	1.77
"Anastrozole is an oral aromatase inhibitor that decreases estrogen production and increases androgen production in men."	( Effect of aromatase inhibition on bone metabolism in elderly hypogonadal men. Finkelstein, JS; Leder, BZ, 2005)	1.05
"Anastrozole is an effective and well-tolerated preoperative therapy, producing clinically beneficial tumor downstaging and reductions in tumor volume. "	( Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Bines, J; Buzdar, AU; Cataliotti, L; de Oliveira, CT; Dube, P; Noguchi, S; Petrakova, K; Takatsuka, Y, 2006)	2.14
"Anastrozole is a nonsteroidal, third-generation aromatase inhibitor, which is heralded as an effective alternative endocrine therapy to tamoxifen in postmenopausal women with hormone-responsive breast cancer. "	( The adjuvant endocrine treatment revolution: focus on anastrozole. Jakesz, R, 2006)	2.02
"Anastrozole is a cost-effective alternative to tamoxifen for the primary adjuvant treatment of postmenopausal women with HR+ EBC."	( Cost-effectiveness analysis of anastrozole versus tamoxifen as primary adjuvant therapy for postmenopausal women with early breast cancer: a US healthcare system perspective. The 5-year completed treatment analysis of the ATAC ('Arimidex', Tamoxifen Alone Cella, D; Dobrez, D; Gandhi, SK; Locker, GY; Mansel, R; Sorensen, S, 2007)	2.07
"Anastrozole is a third-generation aromatase inhibitor with an extensive evidence base to preferentially support its use in multiple scenarios in endocrine-responsive breast cancer. "	( Anastrozole for malignant and benign conditions: present applications and future therapeutic integrations. Graham, PH, 2007)	3.23
"Anastrozole is a third-generation nonsteroidal aromatase inhibitor which is used in the treatment of breast cancers. "	( The effects of anastrozole on neonatal rat skin. Akcali, C; Demirtas, OC; Inaloz, S; Karakok, M; Kirtak, N, 2007)	2.14
"Anastrozole is a new potent and highly selective non-steroidal aromatase inhibitor."	( A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancer. Azab, M; Blomqvist, C; Eiermann, W; Hellmund, R; Howell, A; Jonat, W; Lundgren, S; Mauriac, L; Roche, H; Tyrrell, C; Winblad, G, 1996)	1.24
"Anastrozole is a comparatively simple, achiral benzyltriazole derivative, 2,2'-[5-(1H-1,2,4-triazol-1-ylmethyl)-1,3-phenylene]bis(2-++ +methylpropiononitrile), that inhibits human placental aromatase with an IC50 of 15 nM and elicits maximal activity in vivo in rats (inhibition of ovulation and androstenedione-induced uterine hypertrophy) and monkeys (lowering of plasma oestradiol) at 0.1 mg/kg p.o. "	( The preclinical pharmacology of "Arimidex" (anastrozole; ZD1033)--a potent, selective aromatase inhibitor. Boyle, T; Dukes, M; Edwards, PN; Large, M; Smith, IK, 1996)	2
"Anastrozole is a new oral aromatase inhibitor with highly potent and selective activity for the aromatase enzyme. "	( A phase III trial comparing anastrozole (1 and 10 milligrams), a potent and selective aromatase inhibitor, with megestrol acetate in postmenopausal women with advanced breast carcinoma. Arimidex Study Group. Buzdar, AU; Jones, SE; Plourde, P; Vogel, CL; Webster, A; Wolter, J, 1997)	2.03
"Anastrozole is a new, highly selective, nonsteroidal aromatase inhibitor capable of maximal estrogen depletion with fewer side effects than other hormonal therapies."	( Anastrozole: a new addition to the armamentarium against advanced breast cancer. Buzdar, AU, 1998)	2.46
"Anastrozole is a new oral nonsteroidal aromatase inhibitor indicated for the second-line endocrine treatment of postmenopausal women with advanced breast cancer. "	( Anastrozole. A review of its use in the management of postmenopausal women with advanced breast cancer. Adkins, JC; Wiseman, LR, 1998)	3.19
"Anastrozole (Arimidex) is an oral nonsteroidal aromatase inhibitor which is active in recurrent breast cancer."	( A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Bell, J; Brunetto, VL; Lee, RB; Rose, PG; VanLe, L; Walker, JL, 2000)	1.35
"Anastrozole (Arimidex) is a novel, selective, and potent aromatase inhibitor used for the treatment of postmenopausal breast cancer. "	( Influence of neoadjuvant anastrozole (Arimidex) on intratumoral estrogen levels and proliferation markers in patients with locally advanced breast cancer. Berntsen, H; Detre, S; Dowsett, M; Einstein Lønning, P; Geisler, J; Lindtjørn, B; Ottestad, L, 2001)	2.06
"Anastrozole (Arimidex) is a third-generation aromatase inhibitor which has been shown to possess superior efficacy and tolerability over established endocrine agents in advanced breast cancer. "	( Anastrozole (Arimidex)--an aromatase inhibitor for the adjuvant setting? Buzdar, AU, 2001)	3.2
"Anastrozole is an effective and well tolerated endocrine option for the treatment of postmenopausal patients with hormone-sensitive early breast cancer. "	( Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Baum, M; Budzar, AU; Cuzick, J; Forbes, J; Houghton, JH; Klijn, JG; Sahmoud, T, 2002)	3.2

Excerpt	Reference	Relevance
"Anastrozole has a high affinity for aromatase, a CYP enzyme involved in estrogen synthesis, and provides effective estrogen suppression with little, if any, impact on other CYP enzymes, lipid profiles or steroidogenesis."	( The adjuvant endocrine treatment revolution: focus on anastrozole. Jakesz, R, 2006)	1.3
"Anastrozole has a high pregnancy rate, although it induces fewer ovulatory follicles compared with clomiphene citrate. "	( A randomized comparison of ovulation induction and hormone profile between the aromatase inhibitor anastrozole and clomiphene citrate in women with infertility. Cheng, ML; Hsieh, JN; Wang, NM; Wu, HH, 2007)	2
"Anastrozole has a better therapeutic index (fewer side-effects) and has recently been approved by the FDA and a number of other regulatory agencies around the world for the treatment of advanced breast cancer."	( ARIMIDEX: a potent and selective aromatase inhibitor for the treatment of advanced breast cancer. Buzdar, AU; Howell, A; Jonat, W; Plourde, PV, 1997)	1.02
"Anastrozole has been associated with substantial accelerated bone mineral density (BMD) loss during active treatment."	( Off-treatment bone mineral density changes in postmenopausal women receiving anastrozole for 5 years: 7-year results from the IBIS-II prevention trial. Blake, G; Coleman, R; Cuzick, J; Eastell, R; Howell, A; Patel, R; Sestak, I, 2021)	2.29
"Anastrozole has shown promising results in the adjuvant treatment of early-stage breast cancer in postmenopausal women."	( Use of anastrozole in the chemoprevention and treatment of breast cancer: A literature review. Andrade, DB; Barros-Oliveira, MDC; Borges, RS; Borges, US; Costa-Silva, DR; Silva, BBD; Silva, JM; Tavares, CB, 2017)	1.63
"Anastrozole has been shown to prevent breast cancer in postmenopausal women at high risk of the disease, but has been associated with substantial accelerated loss of bone mineral density (BMD) and increased fractures. "	( Comparison of risedronate versus placebo in preventing anastrozole-induced bone loss in women at high risk of developing breast cancer with osteopenia. Blake, GM; Coleman, RE; Cuzick, J; Eastell, R; Patel, R; Sestak, I, 2019)	2.2
"Anastrozole has also been shown to be a potent suppressor of intratumoural oestrogens, with responses comparable to those in serum."	( Anastrozole in the management of breast cancer. Nabholtz, JM; Reese, D, 2002)	2.48
"Anastrozole treatment has no impact on plasma lipid levels, whereas both letrozole and exemestane have an unfavorable effect."	( Pharmacology and pharmacokinetics of the newer generation aromatase inhibitors. Buzdar, AU, 2003)	1.04
"Anastrozole has a high affinity for aromatase, a CYP enzyme involved in estrogen synthesis, and provides effective estrogen suppression with little, if any, impact on other CYP enzymes, lipid profiles or steroidogenesis."	( The adjuvant endocrine treatment revolution: focus on anastrozole. Jakesz, R, 2006)	1.3
"Anastrozole has a high pregnancy rate, although it induces fewer ovulatory follicles compared with clomiphene citrate. "	( A randomized comparison of ovulation induction and hormone profile between the aromatase inhibitor anastrozole and clomiphene citrate in women with infertility. Cheng, ML; Hsieh, JN; Wang, NM; Wu, HH, 2007)	2
"Anastrozole has been applied to the management of a number of endocrine conditions other than breast cancer."	( Anastrozole for malignant and benign conditions: present applications and future therapeutic integrations. Graham, PH, 2007)	2.5
"Anastrozole has also been used in the treatment of dermatomyositis skin eruptions but its direct effects on skin have not been well documented."	( The effects of anastrozole on neonatal rat skin. Akcali, C; Demirtas, OC; Inaloz, S; Karakok, M; Kirtak, N, 2007)	1.41
"Anastrozole has a better therapeutic index (fewer side-effects) and has recently been approved by the FDA and a number of other regulatory agencies around the world for the treatment of advanced breast cancer."	( ARIMIDEX: a potent and selective aromatase inhibitor for the treatment of advanced breast cancer. Buzdar, AU; Howell, A; Jonat, W; Plourde, PV, 1997)	1.02
"Anastrozole has minimal activity in an unselected population of patients with recurrent endometrial cancer."	( A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Bell, J; Brunetto, VL; Lee, RB; Rose, PG; VanLe, L; Walker, JL, 2000)	2.07
"Anastrozole has shown to be at least as effective as tamoxifen, standard endocrine therapy for breast cancer, with good safety profiles."	( [Development of a novel aromatase inhibitor, anastrozole (Arimidex)--its basic and clinical studies]. Tsukagoshi, S, 2001)	1.29
"Anastrozole has excellent antitumor activity in postmenopausal women, but no data exist on its efficacy in men."	( Efficacy of anastrozole in male breast cancer. Buzdar, AU; Giordano, SH; Hortobagyi, GN; Valero, V, 2002)	1.41

Excerpt	Reference	Relevance
"Anastrozole and letrozole produce similar effects on bone metabolism and turnover."	( A study of the effects of the aromatase inhibitors anastrozole and letrozole on bone metabolism in postmenopausal women with estrogen receptor-positive breast cancer. Dixon, JM; Hannon, R; Macaskill, EJ; McCaig, FM; McHugh, M; Murray, J; Renshaw, L; Williams, L; Young, O, 2010)	1.33
"Anastrozole induced an increase in bone remodelling: osteocalcin (+36.6%, p<0.0001) and CTX (+34%, p<0.0001)."	( Estrogen-dependent increase in bone turnover and bone loss in postmenopausal women with breast cancer treated with anastrozole. Prevention with bisphosphonates. Brun, J; Confavreux, CB; Delmas, PD; Fontana, A; Guastalla, JP; Munoz, F, 2007)	1.27

Excerpt	Reference	Relevance
"For anastrozole-treated patients, predictive factors included baseline body mass index (BMI) and longitudinal patient-reported symptoms such as insomnia, joint pain, hot flashes, headaches, gynecologic symptoms, and vaginal discharge, all collected up to 12 months [Brier score, 0.039; AUC, 0.76; 95% confidence interval (CI), 0.57-0.95]."	( Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial. Calsavara, VF; Cecchini, RS; Diniz, MA; Ganz, PA; Gresham, G; Hays, RD; Henry, NL; Kim, S; Luu, M; Rogatko, A; Tighiouart, M; Yothers, G, 2023)	1.39
"Anastrozole treatment in compliant patients leads to a decrease in BMD (g/cm(2)) at lumbar spine and total hip from baseline to 12 and 24 months (-2.57 % P = 0.004; -2.02 % P = 0.05; -2.57 % P = 0.001 and -4.18 % P = 0.003, respectively) compared to non-compliant patients (-1.71 % P = 0.050; -2.00 % P = 0.085; -1.65 % P = 0.055 and -3.20 % P = 0.005, respectively)."	( Influence of compliance on bone mineral density changes in postmenopausal women with early breast cancer on Anastrozole. Hadji, P; Hars, O; Kalder, M; Knöll, D; Kyvernitakis, I; Ziller, V, 2013)	2.05
"Anastrozole treatment in compliant patients with breast cancer resulted in a larger, increase in bone loss at 12 and 24 months compared to non-compliant patients. "	( Influence of compliance on bone mineral density changes in postmenopausal women with early breast cancer on Anastrozole. Hadji, P; Hars, O; Kalder, M; Knöll, D; Kyvernitakis, I; Ziller, V, 2013)	2.05
"Anastrozole treatment led to decreases of 92.1% for estradiol and 11.1% for LH over the observation period (p < 0.001)."	( Effect of anastrozole on hormone levels in postmenopausal women with early breast cancer. Albert, US; Hadji, P; Hars, O; Kalder, M; Kyvernitakis, I; Winarno, AS, 2015)	1.54
"Anastrozole treatment reversed the impaired bone morphogenetic protein receptor 2 pathway in females."	( Sex-dependent influence of endogenous estrogen in pulmonary hypertension. Duggan, N; Fullerton, J; Hussey, MJ; Loughlin, L; MacLean, MR; Mair, KM; Nilsen, M; Roberts, S; Rowlands, DJ; Thomas, M; Wright, AF, 2014)	1.12
"Anastrozole treatment blocked ARO activity in hippocampal and ovarian microsomes, indicating that the assay is specific for ARO."	( A microsomal based method to detect aromatase activity in different brain regions of the rat using ultra performance liquid chromatography-mass spectrometry. Gibbs, RB; Li, J; Oberly, PJ; Poloyac, SM, 2016)	1.16
"Anastrozole treatment significantly reduced Ki-67 expression in the mammary epithelium of rats in persistent estrus."	( Ki-67 antigen expression in the mammary epithelium of female rats in persistent estrus treated with anastrozole. Alencar, AP; Andrade, DB; Barros-Oliveira, MDC; Borges, RS; Borges, US; Costa-Silva, DR; da Silva, BB; Lopes-Costa, PV; Silva, VC, 2017)	2.11
"Anastrozole treatment is associated with a risk of thromboembolic events and retinal vascular side effects."	( Hemicentral retinal artery occlusion in a breast cancer patient using anastrozole. Ayata, A; Bilgi, O; Kandemir, EG; Karagöz, B; Ozgün, A; Türken, O; Unal, M; Uzun, G, 2009)	1.31
"Anastrozole treatment was started after surgery, adjuvant chemotherapy, and radiotherapy."	( Hemicentral retinal artery occlusion in a breast cancer patient using anastrozole. Ayata, A; Bilgi, O; Kandemir, EG; Karagöz, B; Ozgün, A; Türken, O; Unal, M; Uzun, G, 2009)	1.31
"anastrozole in treatment-naïve patients and in patients already receiving letrozole."	( Cost effectiveness of letrozole versus anastrozole in postmenopausal women with HR+ early-stage breast cancer. Delea, TE; Guo, A; Lipsitz, M, 2010)	1.35
"Anastrozole treatment-related bone loss did not continue into the off-treatment follow-up period. "	( Long-term effects of anastrozole on bone mineral density: 7-year results from the ATAC trial. Adams, J; Beckmann, MW; Clack, G; Coleman, RE; Cuzick, J; Eastell, R; Howell, A; Mackey, J, 2011)	2.13
"Anastrozole-treated mice gained significantly more weight despite consuming significantly less hydration gel compared to vehicle treated mice."	( A novel approach for long-term oral drug administration in animal research. Borgia, JA; Mufson, EJ; Overk, CR, 2011)	1.09
"Anastrozole treatment increases bone turnover more in younger postmenopausal women with breast cancer than in older women compared to healthy controls."	( Does anastrozole affect bone resorption similarly in early and late postmenopausal women? Cochrane, RA; Davie, MW; Powell, DE, 2011)	1.6
"Anastrozole treatment also attenuated urine albumin excretion by 42%, glomerulosclerosis by 30%, tubulointerstitial fibrosis by 32%, along with a decrease in the density of renal cortical CD68-positive cells by 50%, and protein expression of transforming growth factor-β by 20%, collagen type IV by 29%, tumor necrosis factor-α by 28%, and interleukin-6 by 25%."	( Inhibition of estradiol synthesis attenuates renal injury in male streptozotocin-induced diabetic rats. Flynn, ER; Manigrasso, MB; Marbury, DC; Maric, C; Sawyer, RT, 2011)	1.09
"Anastrozole treatment had no impact on plasma lipid levels, whereas both letrozole and exemestane had an unfavorable effect on plasma lipid levels."	( An overview of the pharmacology and pharmacokinetics of the newer generation aromatase inhibitors anastrozole, letrozole, and exemestane. Buzdar, AU; Eiermann, W; Nabholtz, JM; Robertson, JF, 2002)	1.25
"Anastrozole treatment has no impact on plasma lipid levels, whereas both letrozole and exemestane have an unfavorable effect."	( Pharmacology and pharmacokinetics of the newer generation aromatase inhibitors. Buzdar, AU, 2003)	1.04
"Anastrozole treatment was well tolerated."	( Safety and efficacy of anastrozole for the treatment of pubertal gynecomastia: a randomized, double-blind, placebo-controlled trial. Backeljauw, PF; Bercu, BB; Desrochers, PE; Diamond, FB; Jou, HC; Plourde, PV; Reiter, EO; Rubin, SD, 2004)	1.36
"Anastrozole treatment potently decreases estrogen concentrations in adolescent males with GHD while allowing normal virilization, without deleterious effects on body composition, plasma lipids, bone metabolism or the tempo of puberty. "	( An open label 12-month pilot trial on the effects of the aromatase inhibitor anastrozole in growth hormone (GH)-treated GH deficient adolescent boys. Klein, KO; Mauras, N; Rini, A; Welch, S, 2004)	2
"The anastrozole-treated patients were projected to experience a 5.6% absolute risk reduction of first breast cancer recurrence and a 2.8% absolute risk reduction in breast cancer death."	( Anastrozole is cost-effective vs tamoxifen as initial adjuvant therapy in early breast cancer: Canadian perspectives on the ATAC completed-treatment analysis. Rocchi, A; Verma, S, 2006)	2.26
"Treatment with anastrozole increased the ITT/ITE2 ratio and decreased aromatase expression."	( Testicular Testosterone and Estradiol Concentrations and Aromatase Expression in Men with Nonobstructive Azoospermia. Matsuyama, H; Oka, S; Shiraishi, K, 2021)	0.96
"Treatment with anastrozole was stopped after 5.6 years (4.0-6.8)."	( Long-term Effect of Aromatase Inhibition in Aromatase Excess Syndrome. Binder, G; Fukami, M; Nagasaki, K; Nakamura, A; Ogata, T; Schweizer, R, 2021)	0.96
"Treatment with anastrozole caused a significant decrease in proliferation as demonstrated by decreased ki-67 expression. "	( Neoadjuvant treatment of endometrial cancer using anastrozole: a randomised pilot study. Duffy, SR; Hewitt, MJ; Quinton, ND; Thangavelu, A, 2013)	1
"Treatment with anastrozole or letrozole was started on either postoperative day 1 or 28 and continued for 4 weeks."	( Effect of aromatase inhibitors on ectopic endometrial growth and peritoneal environment in a mouse model of endometriosis. Barañao, RI; Bilotas, M; Meresman, G; Stella, I; Sueldo, C, 2010)	0.7
"Treatment with anastrozole was associated with a decreased expression of genes relating to cell proliferation and an increased expression of genes relating to inflammatory processes."	( Gene expression profiling and prediction of response to hormonal neoadjuvant treatment with anastrozole in surgically resectable breast cancer. Baiardi, P; Chiorino, G; Costa, A; Da Prada, GA; Fregoni, V; Ghimenti, C; Grosso, E; Marsoni, S; Mello-Grand, M; Miller, WR; Regolo, L; Scatolini, M; Singh, V; Villani, L; Zambelli, A, 2010)	0.92
"Treatment with anastrozole reduced diabetes-associated increases in plasma estradiol by 39% and increased plasma testosterone levels by 187%."	( Inhibition of estradiol synthesis attenuates renal injury in male streptozotocin-induced diabetic rats. Flynn, ER; Manigrasso, MB; Marbury, DC; Maric, C; Sawyer, RT, 2011)	0.71
"Treatment with anastrozole did not significantly affect fasting lipids, inflammatory markers (IL-6, CRP), adhesion molecules (ICAM-1, VCAM-1) or insulin sensitivity (HOMA). "	( Effect of aromatase inhibition on lipids and inflammatory markers of cardiovascular disease in elderly men with low testosterone levels. Dougherty, RH; Hayden, D; Leder, BZ; Rohrer, JL; Rubin, SD, 2005)	0.68
"Treatment with anastrozole and tamoxifen resulted in differential effects on serum angiogenic markers. "	( The effects of neoadjuvant anastrozole and tamoxifen on circulating vascular endothelial growth factor and soluble vascular endothelial growth factor receptor 1 in breast cancer. A'hern, R; Banerjee, S; Dowsett, M; Ghazoui, Z; Martin, LA; Pancholi, S; Smith, IE, 2008)	1
"Treatment with anastrozole 1 and 10 mg reduced the percentage aromatisation from 2.25% to 0.074% and 0.043% (mean suppression of 96.7% and 98.1% from baseline) and suppressed plasma levels of oestrone, oestradiol and oestrone sulphate by > or = 86.5%, > or = 83.5% and > or = 93.5% respectively, irrespective of dose."	( Influence of anastrozole (Arimidex), a selective, non-steroidal aromatase inhibitor, on in vivo aromatisation and plasma oestrogen levels in postmenopausal women with breast cancer. Dowsett, M; Geisler, J; King, N; Kormeset, PO; Lundgren, S; Lønning, PE; Ottestad, L; Walton, P, 1996)	1
"Treatment with anastrozole suppressed tissue E(2), E(1), and E(1)S levels by 89.0% (73.2--95.5%), 83.4% (63.2--92.5%), and 72.9% (47.3--86.1%), respectively, compared with baseline levels, with no significant difference between responders and nonresponders."	( Influence of neoadjuvant anastrozole (Arimidex) on intratumoral estrogen levels and proliferation markers in patients with locally advanced breast cancer. Berntsen, H; Detre, S; Dowsett, M; Einstein Lønning, P; Geisler, J; Lindtjørn, B; Ottestad, L, 2001)	0.95
"Treatment with anastrozole suppressed plasma levels of E(1), E(2), and E(1)S by a mean of 81.0%, 84.9%, and 93.5%, respectively, whereas treatment with letrozole caused a corresponding decrease of 84.3%, 87.8% and 98.0%, respectively."	( Influence of letrozole and anastrozole on total body aromatization and plasma estrogen levels in postmenopausal breast cancer patients evaluated in a randomized, cross-over study. Anker, G; Dowsett, M; Geisler, J; Haynes, B; Lønning, PE, 2002)	0.95

Excerpt	Reference	Relevance
" Although published information about the side effects of AIs is scarce, it is likely that they will have adverse effects on bone and possibly also on lipid metabolism."	( Safety issues surrounding the use of aromatase inhibitors in breast cancer. Dixon, JM; Jackson, J; Miller, WR, 2003)	0.32
" Safety was determined from adverse event reports and laboratory parameters."	( A phase I study of the pharmacokinetics, pharmacodynamics, and safety of single- and multiple-dose anastrozole in healthy, premenopausal female volunteers. Buraglio, M; Denton, G; Hemsey, G; Tredway, DR, 2004)	0.54
" Clinical trials have begun to define the role of these agents and their unique side-effect profiles."	( Advances in endocrine therapy for breast cancer: considering efficacy, safety, and quality of life. Harwood, KV, 2004)	0.32
" The AIs have differing pharmacological profiles, which may translate into dissimilar adverse event profiles in the adjuvant treatment setting, but patient follow-up in most trials is relatively short to make a valid comparison."	( Safety considerations of adjuvant therapy in early breast cancer in postmenopausal women. Gradishar, WJ, 2005)	0.33
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."	( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004)	0.32
" We calculated a risk-benefit analysis using the two global indices for the Women's Health Initiative and for Disease-Free Survival and Serious Adverse Events."	( Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Buzdar, A; Cuzick, J; Distler, W; Hoctin-Boes, G; Houghton, J; Howell, A; Locker, GY; Nabholtz, JM; Wale, C, 2006)	0.61
"At median follow-up of 68 months (range 1-93), treatment-related adverse events occurred significantly less often with anastrozole than with tamoxifen (1884 [61%] vs 2117 [68%]; p<0."	( Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Buzdar, A; Cuzick, J; Distler, W; Hoctin-Boes, G; Houghton, J; Howell, A; Locker, GY; Nabholtz, JM; Wale, C, 2006)	0.82
"Anastrozole is tolerated better than tamoxifen by postmenopausal women with early-stage breast cancer, and results in fewer serious adverse events."	( Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Buzdar, A; Cuzick, J; Distler, W; Hoctin-Boes, G; Houghton, J; Howell, A; Locker, GY; Nabholtz, JM; Wale, C, 2006)	2.05
"Bone loss may be a potential side effect of implementing aromatase inhibitors in the adjuvant setting."	( Bone safety of aromatase inhibitors versus tamoxifen. Lønning, PE, 2006)	0.33
" Tamoxifen treatment is limited to 5 years because of the development of de novo and acquired resistance, and an ongoing risk of adverse events, including endometrial cancer, thromboembolic events, and gynecological symptoms with long-term use."	( Aromatase inhibitors in the adjuvant treatment of postmenopausal women with early breast cancer: Putting safety issues into perspective. Conte, P; Frassoldati, A, )	0.13
" Generally, adverse events with AIs are predictable and manageable, whereas tamoxifen may be associated with life-threatening events in a minority of patients."	( Safety of aromatase inhibitors in the adjuvant setting. Perez, EA, 2007)	0.34
"Results of the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial have shown that tamoxifen is associated with a significantly higher incidence of gynecologic adverse events than anastrozole."	( A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. Baum, M; Cuzick, J; Distler, W; Duffy, SR; Howell, A, 2009)	0.78
"This was a retrospective analysis of all gynecologic adverse events and interventions conducted in patients receiving anastrozole or tamoxifen in the main ATAC trial database."	( A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. Baum, M; Cuzick, J; Distler, W; Duffy, SR; Howell, A, 2009)	0.79
"Women taking tamoxifen experienced significantly more gynecologic adverse events than those taking anastrozole (34."	( A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. Baum, M; Cuzick, J; Distler, W; Duffy, SR; Howell, A, 2009)	0.8
"The lower incidence of gynecologic adverse events and interventions with anastrozole and the early occurrence of these events provide further support for using anastrozole as the initial adjuvant treatment for early hormone receptor-positive breast cancer."	( A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. Baum, M; Cuzick, J; Distler, W; Duffy, SR; Howell, A, 2009)	0.82
"The main focus of this study was to determine the optimal administration period in terms of toxic effects on ovarian morphological changes."	( Collaborative work on evaluation of ovarian toxicity. 8) Two- or four-week repeated-dose studies and fertility study of Anastrozole in female rats. Furukawa, T; Manabe, S; Matsuyama, T; Saitoh, W; Sakurai, K; Sanbuissho, A; Shirai, M; Teranishi, M, 2009)	0.56
"Although anastrozole (ANA), an aromatase inhibitor (AI), has been widely used for breast cancer patients; adverse events during ANA therapy in Japanese patients have not been reported."	( Adverse events and bone health during anastrozole therapy in postmenopausal Japanese breast cancer patients. Ando, M; Baba, S; Dokiya, F; Douchi, T; Kosha, S; Matsuyama, Y; Ohi, Y; Rai, Y; Sagara, Y; Tamada, S, 2010)	1.05
" Adverse events during ANA therapy, such as musculoskeletal effects and cerebro- and cardiovascular accidents, were investigated over a 5-year period."	( Adverse events and bone health during anastrozole therapy in postmenopausal Japanese breast cancer patients. Ando, M; Baba, S; Dokiya, F; Douchi, T; Kosha, S; Matsuyama, Y; Ohi, Y; Rai, Y; Sagara, Y; Tamada, S, 2010)	0.63
"Incidence of adverse events during AI therapy in this Japanese postmenopausal population appears to be lower than that of the ATAC trial."	( Adverse events and bone health during anastrozole therapy in postmenopausal Japanese breast cancer patients. Ando, M; Baba, S; Dokiya, F; Douchi, T; Kosha, S; Matsuyama, Y; Ohi, Y; Rai, Y; Sagara, Y; Tamada, S, 2010)	0.63
" Our results confirmed that longterm postoperative therapy with UFT alone was feasible, provided that early adverse events are carefully monitored."	( [Safety and compliance with UFT (tegafur and uracil) alone and in combination with hormone therapy in patients with breast cancer]. Noguchi, S; Taguchi, T, 2009)	0.35
"We performed a case-control genome-wide association study (GWAS) to identify single nucleotide polymorphisms (SNPs) associated with musculoskeletal adverse events (MS-AEs) in women treated with aromatase inhibitors (AIs) for early breast cancer."	( Genome-wide associations and functional genomic studies of musculoskeletal adverse events in women receiving aromatase inhibitors. Batzler, A; Chapman, JA; Ellis, MJ; Flockhart, DA; Goetz, MP; Goss, PE; Ingle, JN; Jenkins, GD; Kubo, M; Liu, M; Mushiroda, T; Nakamura, Y; Pater, J; Pritchard, KI; Rohrer, DC; Schaid, DJ; Shepherd, L; Stearns, V; Wang, L; Weinshilboum, RM, 2010)	0.36
" Cases were matched to two controls and were defined as patients with grade 3 or 4 MS-AEs (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events v3."	( Genome-wide associations and functional genomic studies of musculoskeletal adverse events in women receiving aromatase inhibitors. Batzler, A; Chapman, JA; Ellis, MJ; Flockhart, DA; Goetz, MP; Goss, PE; Ingle, JN; Jenkins, GD; Kubo, M; Liu, M; Mushiroda, T; Nakamura, Y; Pater, J; Pritchard, KI; Rohrer, DC; Schaid, DJ; Shepherd, L; Stearns, V; Wang, L; Weinshilboum, RM, 2010)	0.36
" These findings provide a focus for further research to identify patients at risk for MS-AEs and to explore the mechanisms for these adverse events."	( Genome-wide associations and functional genomic studies of musculoskeletal adverse events in women receiving aromatase inhibitors. Batzler, A; Chapman, JA; Ellis, MJ; Flockhart, DA; Goetz, MP; Goss, PE; Ingle, JN; Jenkins, GD; Kubo, M; Liu, M; Mushiroda, T; Nakamura, Y; Pater, J; Pritchard, KI; Rohrer, DC; Schaid, DJ; Shepherd, L; Stearns, V; Wang, L; Weinshilboum, RM, 2010)	0.36
"Health-related quality of life (HRQOL), symptoms of depression, and adverse events (AEs) were compared between Japanese postmenopausal patients with hormone-sensitive breast cancer (BC) who received adjuvant tamoxifen, exemestane, or anastrozole in an open-labeled, randomized, multicenter trial designated as the National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04 substudy of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial."	( Health-related quality of life, psychological distress, and adverse events in postmenopausal women with breast cancer who receive tamoxifen, exemestane, or anastrozole as adjuvant endocrine therapy: National Surgical Adjuvant Study of Breast Cancer 04 (N- Hozumi, Y; Ohashi, Y; Ohsumi, S; Shimozuma, K; Suemasu, K; Takehara, M; Takei, H, 2012)	0.76
" However, the use of both anastrozole and letrozole appears to be safe with concomitant RT, without increasing the risk of pulmonary fibrosis."	( Comparison of the effects of aromatase inhibitors and tamoxifen on radiation-induced lung toxicity: results of an experimental study. Acar, H; Ata, O; Toy, H; Yavas, C; Yavas, G; Yuce, D, 2013)	0.69
"02) and grade III-IV adverse events."	( Efficacy and safety of Trastuzumab added to standard treatments for HER2-positive metastatic breast cancer patients. Chen, ML; Li, K; Zhang, J; Zhu, ZL, 2013)	0.39
" Of note, more adverse events will occur followed the use of trastuzumab, especially cardiac toxicity, with two treatment regimens."	( Efficacy and safety of Trastuzumab added to standard treatments for HER2-positive metastatic breast cancer patients. Chen, ML; Li, K; Zhang, J; Zhu, ZL, 2013)	0.39
" Cutaneous adverse reactions to these drugs have been rarely reported in the literature."	( Cutaneous adverse effects of hormonal adjuvant therapy for breast cancer: a case of localised urticarial vasculitis following anastrozole therapy and a review of the literature. Bock, VL; Friedlander, M; Kossard, S; Waring, D; Wood, GK, 2014)	0.61
"This experimental study aims to investigate whether radiotherapy (RT) plus trastuzumab (T) followed by subsequent hormonotherapy increase the cumulative toxic effect on cardiac functions in rats."	( The effects of hormonotherapy administered concurrent radiotherapy and trastuzumab on cardiac toxicity in rats. Arsav, V; Benderli Cihan, Y, 2014)	0.4
"At the end of the study, no loss and adverse effects were seen in any group."	( The effects of hormonotherapy administered concurrent radiotherapy and trastuzumab on cardiac toxicity in rats. Arsav, V; Benderli Cihan, Y, 2014)	0.4
" The most commonly reported adverse events were 'reproductive system disorders' in the tamoxifen group (17."	( A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer. Chen, D; Deng, Y; Feng, G; He, P; Hu, R; Huang, T; Li, E; Li, L; Li, Y; Liang, Z; Lin, Y; Liu, J; Lu, Y; Ma, R; Su, F; Sun, S; Tong, Z; Wang, S; Wang, X; Wu, Y; Xu, Z; Zhang, H; Zhang, X; Zhang, Y; Zhao, Y, 2014)	0.65
" Nevertheless, this approach is still associated with many challenges, ranging from the recurrence of breast cancer to considerable interindividual variability in the tolerability of anastrozole, which may cause adverse effects, such as musculoskeletal symptoms, and lead to the withdrawal of many patients from treatment."	( The influence of genetic polymorphisms on the efficacy and side effects of anastrozole in postmenopausal breast cancer patients. Abubakar, MB; Gan, SH; Wei, K, 2014)	0.82
" Most common grade 3 to 4 adverse events (> 5% of patients) reported for letrozole versus anastrozole were arthralgia (3."	( Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation Amadori, D; Burris, H; Comarella, L; De Boer, R; Dowsett, M; Ejlertsen, B; Gnant, M; Hart, L; Jonat, W; McIntyre, K; O'Shaughnessy, J; Poggio, S; Pritchard, KI; Salomon, H; Smith, I; Wamil, B; Yardley, D, 2017)	0.92
" The HCS technique also showed toxic effect towards MCF7."	( Cytotoxicity anticancer activities of anastrozole against breast, liver hepatocellular, and prostate cancer cells. Abd-Allateef, M; El-Hiti, GA; Hassan, F; Yousif, E, 2017)	0.73
" The main outcome measures included disease-free survival (DFS), recurrence-free survival (RFS), overall survival (OS), overall response rate (ORR), and adverse events."	( A meta-analysis of randomized controlled trials comparing the efficacy and safety of anastrozole versus tamoxifen for breast cancer. Pan, W; Sun, X; Tang, X; Wu, S; Yang, Y, 2017)	0.68
" Secondary outcomes were adverse events."	( Efficacy and safety of endocrine monotherapy as first-line treatment for hormone-sensitive advanced breast cancer: A network meta-analysis. He, Y; Huang, Y; Wang, C; Wu, K; Zhang, J; Zheng, S, 2017)	0.46
" We directly compared adverse events and found that tamoxifen produced more hot flash events than fulvestrant 250 mg."	( Efficacy and safety of endocrine monotherapy as first-line treatment for hormone-sensitive advanced breast cancer: A network meta-analysis. He, Y; Huang, Y; Wang, C; Wu, K; Zhang, J; Zheng, S, 2017)	0.46
" Anas-associated musculoskeletal symptoms (MS) and other adverse reactions, such as hot flashes (HF) and vaginal dryness/dyspareunia (VDD), are common and can affect the quality of life of BC patients, even sometimes leading to treatment withdrawal."	( Correlation of Serum Estradiol and Duration of Anastrazole Therapy with Treatment Related Adverse Effects Among Postmenopausal Breast Cancer Women: A Cross-sectional Study. Abubakar, MB; Gan, SH, 2017)	0.46
"Combination therapy with CC + AZ is an effective and safe alternative for patients with elevated oestradiol level or low testosterone:oestradiol ratio."	( Combination therapy with clomiphene citrate and anastrozole is a safe and effective alternative for hypoandrogenic subfertile men. Alder, NJ; Hotaling, JM; Keihani, S; Myers, JB; Stoddard, GJ, 2018)	0.74
" No significant serious adverse events were reported during the safety run-in period (n = 6 in V+A arm)."	( Safety and Efficacy of the mTOR Inhibitor, Vistusertib, Combined With Anastrozole in Patients With Hormone Receptor-Positive Recurrent or Metastatic Endometrial Cancer: The VICTORIA Multicenter, Open-label, Phase 1/2 Randomized Clinical Trial. Abdeddaim, C; Arnaud, A; Augereau, P; Bazan, F; Chakiba, C; Chevalier-Place, A; Dalban, C; Diaz, JJ; Fabbro, M; Frenel, JS; Garin, G; Heudel, P; Joly, F; Lancry-Lecomte, L; Marcel, V; Pautier, P; Pérol, D; Ray-Coquard, I; Treilleux, I; You, B, 2022)	0.96
"This multicenter, open-label, phase 1/2 randomized clinical trial demonstrated that adding vistusertib to anastrozole improved 8wk-PFR, overall response rate, and PFS for patients with endometrial cancer and had manageable adverse events."	( Safety and Efficacy of the mTOR Inhibitor, Vistusertib, Combined With Anastrozole in Patients With Hormone Receptor-Positive Recurrent or Metastatic Endometrial Cancer: The VICTORIA Multicenter, Open-label, Phase 1/2 Randomized Clinical Trial. Abdeddaim, C; Arnaud, A; Augereau, P; Bazan, F; Chakiba, C; Chevalier-Place, A; Dalban, C; Diaz, JJ; Fabbro, M; Frenel, JS; Garin, G; Heudel, P; Joly, F; Lancry-Lecomte, L; Marcel, V; Pautier, P; Pérol, D; Ray-Coquard, I; Treilleux, I; You, B, 2022)	1.17

Excerpt	Reference	Relevance
" Blood samples for pharmacokinetic and pharmacodynamic assessment were taken at frequent intervals during each treatment period."	( The effect of anastrozole on the single-dose pharmacokinetics and anticoagulant activity of warfarin in healthy volunteers. März, W; Merz, M; Nauck, M; Seiberling, M; Wong, J; Yates, RA, 2001)	0.67
" In addition, anastrozole had no clinically significant effect on the pharmacodynamic effects of warfarin, as assessed 240 h after warfarin dosing by measurement of prothrombin time (s) (glsmean, anastrozole 11."	( The effect of anastrozole on the single-dose pharmacokinetics and anticoagulant activity of warfarin in healthy volunteers. März, W; Merz, M; Nauck, M; Seiberling, M; Wong, J; Yates, RA, 2001)	1.03
" Anastrozole had no effect on clotting mechanisms or on the pharmacodynamic activity of warfarin, as assessed by prothrombin time, thrombin time, activated partial thromboplastin time, and factor VII."	( The effect of anastrozole on the single-dose pharmacokinetics and anticoagulant activity of warfarin in healthy volunteers. März, W; Merz, M; Nauck, M; Seiberling, M; Wong, J; Yates, RA, 2001)	1.58
" Patients included in the pharmacokinetic (PK) sub-protocol had been in ATAC for > or =3 months, taking their medication in the morning and were 100% compliant for the preceding 14 days."	( Pharmacokinetics of anastrozole and tamoxifen alone, and in combination, during adjuvant endocrine therapy for early breast cancer in postmenopausal women: a sub-protocol of the 'Arimidex and tamoxifen alone or in combination' (ATAC) trial. Cuzick, J; Dowsett, M; Howell, A; Jackson, I, 2001)	0.63
" This method has been applied to the oral pharmacokinetic study of anastrozole in healthy Chinese male volunteers."	( Rapid determination of anastrozole in plasma by gas chromatography with electron capture detection and its application to an oral pharmacokinetic study in healthy volunteers. Duan, G; Liang, J; Zuo, M, 2002)	0.86
"In the absence of data from direct clinical comparisons, the published literature was reviewed for the clinical pharmacology, pharmacokinetic characteristics, and selectivity profiles of anastrozole, letrozole, and exemestane."	( An overview of the pharmacology and pharmacokinetics of the newer generation aromatase inhibitors anastrozole, letrozole, and exemestane. Buzdar, AU; Eiermann, W; Nabholtz, JM; Robertson, JF, 2002)	0.72
" The pharmacokinetic properties of each aromatase inhibitor influences their ability to perform effectively."	( Pharmacokinetics of third-generation aromatase inhibitors. Lønning, P; Martoni, A; Pfister, C; Zamagni, C, 2003)	0.32
" This HPLC-MS-MS procedure was used to assess pharmacokinetic studies."	( Anastrozole quantification in human plasma by high-performance liquid chromatography coupled to photospray tandem mass spectrometry applied to pharmacokinetic studies. De Nucci, G; Hamamoto, D; Ilha, J; Mendes, GD; Pereira, Ados S, 2007)	1.78
"54 liters/h and a terminal half-life of 46."	( Pharmacokinetics and pharmacodynamics of anastrozole in pubertal boys with recent-onset gynecomastia. Agbo, F; Bishop, K; Emeribe, U; Lowe, E; Mauras, N; Merinbaum, D, 2009)	0.62
"A fast, selective and sensitive ultraperformance liquid chromatography-tandem mass spectrometry method was developed for determination and pharmacokinetic study of anastrozole in human plasma."	( An ultraperformance liquid chromatography-tandem mass spectrometry method for determination of anastrozole in human plasma and its application to a pharmacokinetic study. He, J; Li, F; Qin, F; Xiong, Z; Yu, J; Zhang, Y, 2011)	0.78
" The present method was applied successfully to the pharmacokinetic study of anastrozole after oral administration of 1 mg anastrozole tablet to healthy male volunteers."	( Hydrophilic interaction chromatography-electrospray ionization tandem mass spectrometric analysis of anastrozole in human plasma and its application to a pharmacokinetic study. Ji, HY; Lee, HS; Sohn, JH, 2012)	0.82
" Pharmacokinetic results suggest that simvastatin is not likely to compromise the activity of anastrozole."	( Effect of simvastatin on the pharmacokinetics of anastrozole. Bao, T; Blackford, AL; Stearns, V, 2012)	0.85
" Subjects were randomized to receive 1 mg of the test or reference formulation, and pharmacokinetic (PK) parameters were measured."	( Pharmacokinetic comparison of 2 formulations of anastrozole (1 mg) in healthy Korean male volunteers: a randomized, single-dose, 2-period, 2-sequence, crossover study. Bae, KS; Cho, SH; Choe, S; Ghim, JL; Jin, SJ; Jung, JA; Kim, UJ; Ko, YJ; Lim, HS; Noh, YH; Park, HJ; Song, GS, 2012)	0.63
" The method was successfully applied to a pharmacokinetic study of 40 mg anaprazole enteric-coated tablets in 14 Chinese healthy volunteers under fasting or high fat diet conditions."	( [Determination of anaprazole in human plasma by LC-MS/MS in pharmacokinetic study]. Chen, XY; Cheng, DX; Dai, XJ; Li, J; Ma, XF; Shi, CT; Wu, YQ; Zhang, YF; Zhong, DF, 2016)	0.43
" This phase I study assessed the safety and pharmacokinetic (PK) profiles of olaparib combined with tamoxifen, anastrozole or letrozole in patients with advanced solid tumours."	( Pharmacokinetic Effects and Safety of Olaparib Administered with Endocrine Therapy: A Phase I Study in Patients with Advanced Solid Tumours. Bailey, C; Birkett, J; De Grève, J; De Vos, FYFL; Dean, E; Dirix, L; Goessl, C; Grundtvig-Sørensen, P; Italiano, A; Jerusalem, G; Learoyd, M; Leunen, K; Molife, LR; Plummer, R; Rolfo, C; Rottey, S; Spencer, S; Spicer, J; Verheul, HM, 2018)	0.69
" This paper has compared the pharmacokinetic parameters with oral tablets (Aida®) in mini pigs and evaluated the uterine targeted effect and mucosal irritation of the ring."	( A novel anastrozole intravaginal ring for endometriosis: Pharmacokinetic characteristics and mucosal irritation. Dong, J; Ma, B; Ning, M; Wu, S; Yang, Z, 2023)	1.34

Excerpt	Reference	Relevance
"The Immediate Preoperative Anastrozole, Tamoxifen, or Combined With Tamoxifen (IMPACT) trial was designed to test the hypothesis that the clinical and/or biologic effects of neoadjuvant tamoxifen compared with anastrozole and with the combination of tamoxifen and anastrozole before surgery in postmenopausal women with estrogen receptor (ER) -positive, invasive, nonmetastatic breast cancer might predict for outcome in the Arimidex, Tamoxifen Alone or in Combination (ATAC) adjuvant therapy trial."	( Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial. Ashley, SE; Blohmer, JU; Boeddinghaus, I; Dixon, JM; Dowsett, M; Ebbs, SR; Francis, S; Skene, A; Smith, IE; Walsh, G, 2005)	0.87
" Tegafur and Uracil (UFT) have been widely used for the postoperative chemotherapy of breast cancer, and often combined with hormonal agents."	( [Safety and compliance with UFT (tegafur and uracil) alone and in combination with hormone therapy in patients with breast cancer]. Noguchi, S; Taguchi, T, 2009)	0.35
"This phase II randomized trial evaluated the efficacy and tolerability of anastrozole combined with gefitinib or anastrozole with placebo in women with hormone receptor-positive metastatic breast cancer (MBC)."	( Phase II, randomized trial to compare anastrozole combined with gefitinib or placebo in postmenopausal women with hormone receptor-positive metastatic breast cancer. Anderson, E; Arena, FP; Bacus, S; Cora, EM; Cristofanilli, M; Curcio, E; Kroener, JF; Magill, PJ; Mangalik, A; Rabinowitz, I; Royce, M; Valero, V; Watkins, C, 2010)	0.86
"This small randomized study showed that anastrozole in combination with gefitinib is associated with a marked advantage in PFS compared with anastrozole plus placebo, and that the combination was tolerated in postmenopausal women with hormone receptor-positive MBC."	( Phase II, randomized trial to compare anastrozole combined with gefitinib or placebo in postmenopausal women with hormone receptor-positive metastatic breast cancer. Anderson, E; Arena, FP; Bacus, S; Cora, EM; Cristofanilli, M; Curcio, E; Kroener, JF; Magill, PJ; Mangalik, A; Rabinowitz, I; Royce, M; Valero, V; Watkins, C, 2010)	0.9
"To review the clinical effectiveness and cost-effectiveness evidence base for lapatinib (LAP) in combination with an aromatase inhibitor (AI) and trastuzumab (TRA) in combination with an AI for the first-line treatment of patients who have hormone receptor-positive (HR+)/human epidermal growth factor 2-positive (HER2+) mBC."	( Lapatinib and trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor-positive breast cancer which over-expresses human epidermal growth factor 2 (HER2): a systematic review and economic analysis. Armstrong, A; Bagust, A; Blundell, M; Boland, A; Davis, H; Dickson, R; Dundar, Y; Fleeman, N; Moonan, M; Oyee, J; Thorp, N, 2011)	0.37
"Three trials were included in the systematic review [the patient populations of the efficacy and safety of lapatinib combined with letrozole (EGF30008) trial, the efficacy and safety of trastuzumab combined with anastrozole (TAnDEM) trial and the efficacy and safety of letrozole combined with trastuzumab (eLEcTRA) trial]."	( Lapatinib and trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor-positive breast cancer which over-expresses human epidermal growth factor 2 (HER2): a systematic review and economic analysis. Armstrong, A; Bagust, A; Blundell, M; Boland, A; Davis, H; Dickson, R; Dundar, Y; Fleeman, N; Moonan, M; Oyee, J; Thorp, N, 2011)	0.56
" Preclinical work suggested potential synergy of fulvestrant in combination with aromatase inhibitor therapy and delayed development of endocrine resistance."	( A meta-analysis of anastrozole in combination with fulvestrant in the first line treatment of hormone receptor positive advanced breast cancer. Haaland, B; Lopes, G; Montero, AJ; Tan, PS, 2013)	0.72
"To evaluate the inhibitory effect of genistin combined with anastrozole on the growth and apoptosis of breast tumor tissue, and to study their anti-cancer mechanism by using the model of 7,12-dimethylbenz [alpha] anthracene (DMBA)-induced mammary tumors following ovariectomy in Sprague-Dawley (SD) rats."	( [Effect of genistein combined with anastrozole on mammary tumors in ovariectomized rats]. Kang, XM; Ma, WJ; Song, Y; Wang, L; Zhang, QY; Zhao, H, 2014)	0.92
"The DMBA induced postmenopausal SD rats were randomly divided into the control group, the genistein group, the anastrozole group, and the genistein combined with anastrozole group."	( [Effect of genistein combined with anastrozole on mammary tumors in ovariectomized rats]. Kang, XM; Ma, WJ; Song, Y; Wang, L; Zhang, QY; Zhao, H, 2014)	0.89
" It showed synergistic effect when combined with anastrozole, which resulted in reduced levels of E2 and 17beta-HSD1 mRNA."	( [Effect of genistein combined with anastrozole on mammary tumors in ovariectomized rats]. Kang, XM; Ma, WJ; Song, Y; Wang, L; Zhang, QY; Zhao, H, 2014)	0.93
" Subsequently, the effects of mSGLXD alone or in combination with anastrozole on osteoblastic MC3T3‑E1 cell proliferation and differentiation were investigated."	( Effects of modified Shu-Gan-Liang-Xue decoction combined with anastrozole on osteoblastic proliferation and differentiation of MC3T3-E1 cells. Han, S; Li, P; Zheng, W; Zhou, F; Zhou, N, 2015)	0.89
" After promising preclinical modeling of MK-2206, an allosteric pan-AKT inhibitor, with either estrogen deprivation or fulvestrant, we conducted a phase I trial in patients with metastatic ER(+)HER2(-) breast cancer to determine the recommended phase II treatment dose (RPTD) of MK-2206 when combined with either anastrozole, fulvestrant, or anastrozole/fulvestrant."	( A Phase I Study of the AKT Inhibitor MK-2206 in Combination with Hormonal Therapy in Postmenopausal Women with Estrogen Receptor-Positive Metastatic Breast Cancer. Creekmore, A; Crowder, R; Doyle, A; Ellis, MJ; Erlichman, C; Gao, F; Guo, Z; Hoog, J; Lockhart, AC; Ma, CX; Naughton, M; Pluard, T; Sanchez, C, 2016)	0.61
" MK-2206 in combination with anastrozole is being further evaluated in a phase II neoadjuvant trial for newly diagnosed ER(+)HER2(-) breast cancer."	( A Phase I Study of the AKT Inhibitor MK-2206 in Combination with Hormonal Therapy in Postmenopausal Women with Estrogen Receptor-Positive Metastatic Breast Cancer. Creekmore, A; Crowder, R; Doyle, A; Ellis, MJ; Erlichman, C; Gao, F; Guo, Z; Hoog, J; Lockhart, AC; Ma, CX; Naughton, M; Pluard, T; Sanchez, C, 2016)	0.73
"Patients were randomized 1:1:1 to receive daily anastrozole (1 mg) in combination with AZD8931 20 mg twice daily (bid), AZD8931 40 mg bid, or placebo."	( Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naïve advanced breast cancer. Basik, M; Clemons, M; Cristofanilli, M; Dreosti, L; Grzeda, L; Hegg, R; Johnston, S; Lausoontornsiri, W; Mann, H; Stuart, M, 2016)	0.92
"At the interim analysis, 359 patients were randomized and received anastrozole in combination with AZD8931 20 mg (n = 118), 40 mg (n = 120), or placebo (n = 121); 39 % of patients (n = 141) had a progression event."	( Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naïve advanced breast cancer. Basik, M; Clemons, M; Cristofanilli, M; Dreosti, L; Grzeda, L; Hegg, R; Johnston, S; Lausoontornsiri, W; Mann, H; Stuart, M, 2016)	0.9
"AZD8931, in combination with endocrine therapy, does not appear to enhance endocrine responsiveness and is associated with greater skin and gastrointestinal toxicity."	( Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naïve advanced breast cancer. Basik, M; Clemons, M; Cristofanilli, M; Dreosti, L; Grzeda, L; Hegg, R; Johnston, S; Lausoontornsiri, W; Mann, H; Stuart, M, 2016)	0.66
" Hence, this study was conducted to investigate the comparative pharmacokinetics of anastrozole after single administration and combination with celecoxib."	( Comparative pharmacokinetics study of anastrozole after single administration and combination with celecoxib. Chen, X; Gu, L; Guo, P; Lv, M; Sun, X; Wang, B; Wang, S; Zhao, S, 2018)	0.98
"The PARP inhibitor olaparib is efficacious as monotherapy and has potential application in combination with endocrine therapy for the treatment of breast cancer."	( Pharmacokinetic Effects and Safety of Olaparib Administered with Endocrine Therapy: A Phase I Study in Patients with Advanced Solid Tumours. Bailey, C; Birkett, J; De Grève, J; De Vos, FYFL; Dean, E; Dirix, L; Goessl, C; Grundtvig-Sørensen, P; Italiano, A; Jerusalem, G; Learoyd, M; Leunen, K; Molife, LR; Plummer, R; Rolfo, C; Rottey, S; Spencer, S; Spicer, J; Verheul, HM, 2018)	0.48
" Two hundred sixteen patients were randomized to the treatment group with IVRs releasing LNG 40 μg/day alone or in combination with ATZ 300 μg/day, 600 μg/day, or 1050 μg/day for 12 weeks."	( Absence of Drug-Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial. Höchel, J; Klein, S; Mellinger, U; Nave, R; Schmitz, H, 2019)	0.79
"This post hoc analysis of MONARCH 2 and MONARCH 3 assesses the efficacy, safety, and pharmacokinetics (PK) of abemaciclib in combination with endocrine therapy (ET) in East Asian patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer."	( Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials. André, VAM; Chen, SC; Enatsu, S; Goetz, MP; Hae Park, I; Hardebeck, MC; Im, SA; Inoue, K; Iwata, H; Masuda, N; Sakaguchi, S; Sledge, GW; Sohn, J; Toi, M; Turner, PK, 2021)	0.62
" Our findings showed that antiplatelet therapies (aspirin/clopidogrel cocktail and atopaxar) combined with anastrozole failed to prevent hypercoagulation and induced evidence of a partial EMT."	( Antiplatelet Therapy Combined with Anastrozole Induces Features of Partial EMT in Breast Cancer Cells and Fails to Mitigate Breast-Cancer Induced Hypercoagulation. Augustine, TN; Xulu, KR, 2021)	1.11
"To evaluate the safety and efficacy of vistusertib in combination with anastrozole in the treatment of women with hormone receptor-positive recurrent or metastatic endometrial cancer."	( Safety and Efficacy of the mTOR Inhibitor, Vistusertib, Combined With Anastrozole in Patients With Hormone Receptor-Positive Recurrent or Metastatic Endometrial Cancer: The VICTORIA Multicenter, Open-label, Phase 1/2 Randomized Clinical Trial. Abdeddaim, C; Arnaud, A; Augereau, P; Bazan, F; Chakiba, C; Chevalier-Place, A; Dalban, C; Diaz, JJ; Fabbro, M; Frenel, JS; Garin, G; Heudel, P; Joly, F; Lancry-Lecomte, L; Marcel, V; Pautier, P; Pérol, D; Ray-Coquard, I; Treilleux, I; You, B, 2022)	1.19
" This study provides RiBi-based markers relevant for a better selection of patients with advanced endometrial carcinoma by predicting the response of endocrine therapy combined with mTOR inhibitor."	( Ribosome biogenesis-based predictive biomarkers in endocrine therapy (Anastrozole) combined with mTOR inhibitor (Vistusertib) in endometrial cancer: translational study from the VICTORIA trial in collaboration with the GINECO group. Abadie-Lacourtoisie, S; Bazan, F; Chabaud, S; Colombe-Vermorel, A; Coquan, E; Dalban, C; Diaz, JJ; Fabbro, M; Frenel, JS; Garin, G; Heudel, PE; Marcel, V; Martinez, S; Mourksi, NE; Odeyer, L; Pérol, D; Ray-Coquard, I; Simioni, V; Tabone-Eglinger, S; Treilleux, I, 2023)	1.14

Excerpt	Reference	Relevance
" Bioavailability studies have demonstrated almost complete absorption of anastrozole after oral administration."	( Anastrozole: a selective aromatase inhibitor for the treatment of breast cancer. alKhouri, N; Higa, GM, 1998)	1.97
"The choice of treatment for elderly breast cancer patients needs particular care because the presence of physiological functional impairments can modify the drug bioavailability in an unpredictable manner."	( Steroidal aromatase inhibitors in elderly patients. Bajetta, E; Bichisao, E; Pozzi, P; Toffolatti, L; Zilembo, N, 2000)	0.31
"The concurrent administration of tamoxifen and bicalutamide reduces the synthesis and bioavailability of IGF-1."	( Influence of bicalutamide with or without tamoxifen or anastrozole on insulin-like growth factor 1 and binding proteins in prostate cancer patients. Battaglia, M; Bertaccini, A; Boccardo, F; Conti, G; Romagnoli, A; Rubagotti, A; Zattoni, F, )	0.38
"Lonafarnib is an orally bioavailable farnesyltransferase inhibitor."	( Enhancement of the antitumor activity of tamoxifen and anastrozole by the farnesyltransferase inhibitor lonafarnib (SCH66336). Basso, AD; Black, S; Kirschmeier, P; Liu, G; Liu, M; Long, BJ; Marrinan, CH; Robert Bishop, W; Taylor, SA, 2007)	0.59
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."	( Hologram QSAR model for the prediction of human oral bioavailability. Andricopulo, AD; Moda, TL; Montanari, CA, 2007)	0.34
" We assessed whether the addition of a lower dose of tamoxifen influenced anastrozole bioavailability and favorably modulated biomarkers of bone fracture, breast cancer, cardiovascular disease, and endometrial cancer risk."	( Randomized biomarker trial of anastrozole or low-dose tamoxifen or their combination in subjects with breast intraepithelial neoplasia. Bonanni, B; Cassano, E; Cazzaniga, M; Decensi, A; Gandini, S; Guerrieri-Gonzaga, A; Johansson, H; Lien, EA; Luini, A; Macis, D; Oldani, S; Pelosi, G; Serrano, D, 2009)	0.87
"The addition of a weekly tamoxifen administration did not impair anastrozole bioavailability and modulated favorably its safety profile, providing the rationale for further studies."	( Randomized biomarker trial of anastrozole or low-dose tamoxifen or their combination in subjects with breast intraepithelial neoplasia. Bonanni, B; Cassano, E; Cazzaniga, M; Decensi, A; Gandini, S; Guerrieri-Gonzaga, A; Johansson, H; Lien, EA; Luini, A; Macis, D; Oldani, S; Pelosi, G; Serrano, D, 2009)	0.88
" We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers."	( Pharmacokinetic comparison of 2 formulations of anastrozole (1 mg) in healthy Korean male volunteers: a randomized, single-dose, 2-period, 2-sequence, crossover study. Bae, KS; Cho, SH; Choe, S; Ghim, JL; Jin, SJ; Jung, JA; Kim, UJ; Ko, YJ; Lim, HS; Noh, YH; Park, HJ; Song, GS, 2012)	0.63
"An early prediction of solubility in physiological media (PBS, SGF and SIF) is useful to predict qualitatively bioavailability and absorption of lead candidates."	( Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery. Bharate, SS; Vishwakarma, RA, 2015)	0.42
" Total body clearance and bioavailability were 12."	( Comparison of pharmacokinetics of newly discovered aromatase inhibitors by a cassette microdosing approach in healthy Japanese subjects. Fujii, H; Hojo, T; Hosoya, T; Inano, A; Ishii, A; Kataoka, M; Kusuhara, H; Sugiyama, Y; Takahashi, K; Takashima, T; Tanaka, M; Tazawa, S; Tokai, H; Watanabe, Y; Yamashita, S; Yano, T; Yoshida, S, 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
" The novel combination of ATZ and PIP was proposed to enhance the bioavailability of both the compounds."	( Simultaneous Method Development and Validation of Anastrozole Along with Piperine: Degradation Studies and Degradants Characterization Using LC-QTOF-ESI-MS Along with In-silico ADMET Predictions. Alexander, A; Gajbhiye, R; Kumar, P; Mehta, P; Murty, US; Pawar, SD; Ravichandiran, V; Sarmah, B; Susanna, KJ, 2022)	0.97

Excerpt	Relevance	Reference
" Volunteers in the first trial were dosed with 3 mg of ZD1033 daily over 10 days to assess the effects on endocrinology of ZD1033 and establish a pharmacokinetic profile."	( Arimidex (ZD1033): a selective, potent inhibitor of aromatase in postmenopausal female volunteers. Dowsett, M; Fisher, GV; Selen, A; Wyld, PJ; Yates, RA, 1996)	0.29
"1 mg/kg, and the clearance half-life of 7-16 h indicated that once-daily dosing would be possible in humans."	( The relevance of preclinical models to the treatment of postmenopausal breast cancer. Dukes, M, 1997)	0.3
" 75, 198-207, 1997) have suggested that dosing chemicals to newly weaned male rats for 1 month may yield a useful assay for antiandrogens."	( The weanling male rat as an assay for endocrine disruption: preliminary observations. Ashby, J; Lefevre, PA, 1997)	0.3
" The recommended dosage is 1 mg daily."	( Anastrozole: a selective aromatase inhibitor for the treatment of breast cancer. alKhouri, N; Higa, GM, 1998)	1.74
" Anastrozole is administered in a convenient, once-daily oral dosing regimen and does not require steroid replacement therapy."	( Anastrozole: a new addition to the armamentarium against advanced breast cancer. Buzdar, AU, 1998)	2.65
" The rationale for extending the use of aromatase inhibitors to the treatment of early breast cancer is based on the efficacy observed in the advanced setting, combined with good tolerability and a convenient dosing regimen."	( Aromatase inhibitors and their future role in post-menopausal women with early breast cancer. Lønning, PE, 1998)	0.3
" Dosing extended over postnatal days (pnd) 22-35, 36-50, 36-55 and 22-35, with recovery to pnd 55 or 22-55."	( The peripubertal male rat assay as an alternative to the Hershberger castrated male rat assay for the detection of anti-androgens, oestrogens and metabolic modulators. Ashby, J; Lefevre, PA, )	0.13
" First, a dose-response study of 12 males (mean age, 16."	( Estrogen suppression in males: metabolic effects. Hayes, V; Klein, KO; Mauras, N; O'Brien, KO, 2000)	0.31
"9 yr) underwent GnRH dose-response studies at baseline and after treatment with dexamethasone (0."	( Differential regulation of gonadotropin secretion by testosterone in the human male: absence of a negative feedback effect of testosterone on follicle-stimulating hormone secretion. Boepple, PA; Crowley, WF; DeCruz, S; Hayes, FJ; Seminara, SB, 2001)	0.31
" In addition, anastrozole had no clinically significant effect on the pharmacodynamic effects of warfarin, as assessed 240 h after warfarin dosing by measurement of prothrombin time (s) (glsmean, anastrozole 11."	( The effect of anastrozole on the single-dose pharmacokinetics and anticoagulant activity of warfarin in healthy volunteers. März, W; Merz, M; Nauck, M; Seiberling, M; Wong, J; Yates, RA, 2001)	1.03
" The reason is that the appropriate dosage is not identical to that of Western countries."	( [Developments of hormonal agents for breast cancer]. Tominaga, T, 2001)	0.31
" It is well tolerated and has a convenient once-daily dosing regimen, ensuring maximum patient compliance."	( Anastrozole (Arimidex)--an aromatase inhibitor for the adjuvant setting? Buzdar, AU, 2001)	1.75
" Preclinical research has demonstrated that the estrogen dose-response curve for breast cancer cells can be shifted by modification of the estrogen environment."	( Estrogen as therapy for breast cancer. Ingle, JN, 2002)	0.31
" The potent estrogen suppressive action and simple dosage regimen of anastrozole suggest it may be advantageous compared to other aromatase inhibitors such as testolactone or anti-estrogens."	( Effective aromatase inhibition by anastrozole in a patient with gonadotropin-independent precocious puberty in McCune-Albright syndrome. Albers, N; Freiberg, C; Roth, C; Zappel, H, 2002)	0.83
"To further delineate the role of estradiol in the IGF system an experiment was conducted to determine the dosage of the aromatase inhibitor, anastrozole, needed to decreases serum concentrations of estradiol-17beta (E2) in maturing boars."	( Effects of decreased estradiol-17beta on the serum and anterior pituitary IGF-I system in pigs. Clapper, JA; Hilleson-Gayne, CK, 2005)	0.53
"To compare the effect on follicular growth and endocrine parameters of follicular phase administration of anastrozole to healthy, normoovulatory women in doses of 1 or 5 mg, respectively, with the conventional dosing regimen for ovulation induction with clomiphene citrate (CC)."	( Follicular and endocrine response to anastrozole versus clomiphene citrate administered in follicular phase to normoovulatory women: a randomized comparison. Diedrich, K; Griesinger, G; Schröer, A; Schultze-Mosgau, A; von Otte, S, 2009)	0.84
" Dosing adjustment in patients with renal dysfunction is not necessary for anastrozole."	( Anastrozole-associated sclerosing glomerulonephritis in a patient with breast cancer. Akgul, B; Camci, C; Kalender, ME; Karakok, M; Sevinc, A; Turk, HM, 2007)	2.01
"We assessed PK/PD of anastrozole after 14 d daily dosing and changes in breast size (exploratory aim) by manual tape measurements (area) and ultrasound (volume) after 6 months."	( Pharmacokinetics and pharmacodynamics of anastrozole in pubertal boys with recent-onset gynecomastia. Agbo, F; Bishop, K; Emeribe, U; Lowe, E; Mauras, N; Merinbaum, D, 2009)	0.94
" Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week."	( Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial. Antonopoulou, Z; Dafni, U; Gogas, H; Kalogerakos, K; Koukouras, D; Lazarou, S; Markopoulos, C; Misitzis, J; Papadiamantis, J; Polychronis, A; Sarantopoulou, A; Siasos, N; Tzoracoleftherakis, E; Venizelos, B; Xepapadakis, G; Zobolas, V, 2010)	1.63
" After 2 years of treatment, anastrozole is still currently used at a dosage of 1 mg once daily with no side effects."	( Prepubertal gynecomastia in two monozygotic twins with Peutz-Jeghers syndrome: two years' treatment with anastrozole and genetic study. Cirillo, G; Coppola, F; del Giudice, EM; Grandone, A; Perrone, L; Santarpia, M, 2011)	0.87
" This delivery system of anastrozole is expected to reduce the side effects associated with the conventional cancer therapy by reducing dosing frequency."	( Application of multiple regression analysis in optimization of anastrozole-loaded PLGA nanoparticles. Kumar, A; Sawant, KK, 2014)	0.95
"The dosage effect of adjuvant treatments, cancer staging, genetic or environmental confounders associated with the risk of depressive disorders were not comprehensively evaluated."	( Adjuvant treatments of breast cancer increase the risk of depressive disorders: A population-based study. Chang, CH; Chen, SJ; Liu, CY, 2015)	0.42
" However, fulvestrant may be potentially more effective than current therapies when given at 500 mg, though this higher dosage was used in only one of the nine studies included in the review."	( Fulvestrant for hormone-sensitive metastatic breast cancer. Goodwin, A; Lee, CI; Wilcken, N, 2017)	0.46
" PK blood samples were taken before dosing and before IVR replacement or removal (days 28, 56, and 84)."	( Absence of Drug-Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial. Höchel, J; Klein, S; Mellinger, U; Nave, R; Schmitz, H, 2019)	0.79
" Subcutaneous anastrozole delivered simultaneously with testosterone allowed for higher dosing of testosterone and less frequent intervals of insertion."	( Subcutaneous Testosterone Anastrozole Therapy in Men: Rationale, Dosing, and Levels on Therapy. Glaser, RL; York, AE, )	0.79
" Hence, rationalizing drug dosage is important."	( Biophysical Insight into the Interaction of Human Lysozyme with Anticancer Drug Anastrozole: A Multitechnique Approach. Abdelhameed, AS; Ajmal, MR; Alawy, AIA; Almutairi, FM; Khan, RH, 2020)	0.79
" Thereafter, the steroid dosage was gradually lowered to 5 mg/day."	( [Case Report of an Elderly Patient with Interstitial Pneumonia Caused by the Administration of Trastuzumab plus Anastrozole for the Treatment of Inflammatory Breast Cancer]. Aizu, K; Fujieda, H; Furuta, M; Iwata, T; Kageyama, Y; Kobayashi, S; Sato, F; Toyoda, Y; Watanabe, S; Yamaguchi, R, 2021)	0.83

Role	Description
antineoplastic agent	A substance that inhibits or prevents the proliferation of neoplasms.
EC 1.14.14.14 (aromatase) inhibitor	An EC 1.14.14.* (oxidoreductase acting on paired donors, incorporating of 1 atom of oxygen, with reduced flavin or flavoprotein as one donor) inhibitor which interferes with the action of aromatase (EC 1.14.14.14) and so reduces production of estrogenic steroid hormones.
[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]

Class	Description
triazoles	An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms.
nitrile	A compound having the structure RC#N; thus a C-substituted derivative of hydrocyanic acid, HC#N. In systematic nomenclature, the suffix nitrile denotes the triply bound #N atom, not the carbon atom attached to it.
[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	Taxonomy	Measurement	Average (µ)	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASE	Homo sapiens (human)	Potency	0.0112	0.0032	45.4673	12,589.2998	AID2517
AR protein	Homo sapiens (human)	Potency	29.8493	0.0002	21.2231	8,912.5098	AID1259243
cytochrome P450 family 3 subfamily A polypeptide 4	Homo sapiens (human)	Potency	9.7717	0.0123	7.9835	43.2770	AID1645841
glucocorticoid receptor [Homo sapiens]	Homo sapiens (human)	Potency	2.6832	0.0002	14.3764	60.0339	AID720691
estrogen nuclear receptor alpha	Homo sapiens (human)	Potency	16.8629	0.0002	29.3054	16,493.5996	AID743075
G	Vesicular stomatitis virus	Potency	6.1655	0.0123	8.9648	39.8107	AID1645842
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_a	Homo sapiens (human)	Potency	0.2267	0.0017	23.8393	78.1014	AID743083
thyroid hormone receptor beta isoform 2	Rattus norvegicus (Norway rat)	Potency	8.3927	0.0003	23.4451	159.6830	AID743065
Interferon beta	Homo sapiens (human)	Potency	6.1655	0.0033	9.1582	39.8107	AID1645842
HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)	Potency	6.1655	0.0123	8.9648	39.8107	AID1645842
Spike glycoprotein	Severe acute respiratory syndrome-related coronavirus	Potency	39.8107	0.0096	10.5250	35.4813	AID1479145
Inositol hexakisphosphate kinase 1	Homo sapiens (human)	Potency	6.1655	0.0123	8.9648	39.8107	AID1645842
cytochrome P450 2C9, partial	Homo sapiens (human)	Potency	6.1655	0.0123	8.9648	39.8107	AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
ATP-binding cassette sub-family C member 3	Homo sapiens (human)	IC50 (µMol)	133.0000	0.6315	4.4531	9.3000	AID1473740
Multidrug resistance-associated protein 4	Homo sapiens (human)	IC50 (µMol)	133.0000	0.2000	5.6774	10.0000	AID1473741
Bile salt export pump	Homo sapiens (human)	IC50 (µMol)	133.0000	0.1100	7.1903	10.0000	AID1473738
Aromatase	Homo sapiens (human)	IC50 (µMol)	0.1443	0.0000	1.2904	10.0000	AID1249548; AID1307752; AID1390538; AID1796387; AID1799682; AID1855795; AID259894; AID282900; AID366344; AID461809; AID479369; AID650842; AID654681
Aromatase	Homo sapiens (human)	Ki	0.0001	0.0000	0.6046	9.5010	AID650843
Cytochrome P450 2C9	Homo sapiens (human)	IC50 (µMol)	0.0036	0.0000	2.8005	10.0000	AID1307752
Amine oxidase [flavin-containing] A	Rattus norvegicus (Norway rat)	IC50 (µMol)	0.0015	0.0007	1.9798	12.5000	AID461809
UDP-glucuronosyltransferase 1A4	Homo sapiens (human)	IC50 (µMol)	4.7200	4.7200	4.8100	4.9000	AID1215864
Canalicular multispecific organic anion transporter 1	Homo sapiens (human)	IC50 (µMol)	133.0000	2.4100	6.3433	10.0000	AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
xenobiotic metabolic process	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
xenobiotic transmembrane transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
bile acid and bile salt transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
glucuronoside transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
xenobiotic transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
transmembrane transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
leukotriene transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
monoatomic anion transmembrane transport	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
transport across blood-brain barrier	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
prostaglandin secretion	Multidrug resistance-associated protein 4	Homo sapiens (human)
cilium assembly	Multidrug resistance-associated protein 4	Homo sapiens (human)
platelet degranulation	Multidrug resistance-associated protein 4	Homo sapiens (human)
xenobiotic metabolic process	Multidrug resistance-associated protein 4	Homo sapiens (human)
xenobiotic transmembrane transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
bile acid and bile salt transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
prostaglandin transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
urate transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
glutathione transmembrane transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
transmembrane transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
cAMP transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
leukotriene transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
monoatomic anion transmembrane transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
export across plasma membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
transport across blood-brain barrier	Multidrug resistance-associated protein 4	Homo sapiens (human)
guanine nucleotide transmembrane transport	Multidrug resistance-associated protein 4	Homo sapiens (human)
fatty acid metabolic process	Bile salt export pump	Homo sapiens (human)
bile acid biosynthetic process	Bile salt export pump	Homo sapiens (human)
xenobiotic metabolic process	Bile salt export pump	Homo sapiens (human)
xenobiotic transmembrane transport	Bile salt export pump	Homo sapiens (human)
response to oxidative stress	Bile salt export pump	Homo sapiens (human)
bile acid metabolic process	Bile salt export pump	Homo sapiens (human)
response to organic cyclic compound	Bile salt export pump	Homo sapiens (human)
bile acid and bile salt transport	Bile salt export pump	Homo sapiens (human)
canalicular bile acid transport	Bile salt export pump	Homo sapiens (human)
protein ubiquitination	Bile salt export pump	Homo sapiens (human)
regulation of fatty acid beta-oxidation	Bile salt export pump	Homo sapiens (human)
carbohydrate transmembrane transport	Bile salt export pump	Homo sapiens (human)
bile acid signaling pathway	Bile salt export pump	Homo sapiens (human)
cholesterol homeostasis	Bile salt export pump	Homo sapiens (human)
response to estrogen	Bile salt export pump	Homo sapiens (human)
response to ethanol	Bile salt export pump	Homo sapiens (human)
xenobiotic export from cell	Bile salt export pump	Homo sapiens (human)
lipid homeostasis	Bile salt export pump	Homo sapiens (human)
phospholipid homeostasis	Bile salt export pump	Homo sapiens (human)
positive regulation of bile acid secretion	Bile salt export pump	Homo sapiens (human)
regulation of bile acid metabolic process	Bile salt export pump	Homo sapiens (human)
transmembrane transport	Bile salt export pump	Homo sapiens (human)
cell surface receptor signaling pathway via JAK-STAT	Interferon beta	Homo sapiens (human)
response to exogenous dsRNA	Interferon beta	Homo sapiens (human)
B cell activation involved in immune response	Interferon beta	Homo sapiens (human)
cell surface receptor signaling pathway	Interferon beta	Homo sapiens (human)
cell surface receptor signaling pathway via JAK-STAT	Interferon beta	Homo sapiens (human)
response to virus	Interferon beta	Homo sapiens (human)
positive regulation of autophagy	Interferon beta	Homo sapiens (human)
cytokine-mediated signaling pathway	Interferon beta	Homo sapiens (human)
natural killer cell activation	Interferon beta	Homo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT protein	Interferon beta	Homo sapiens (human)
cellular response to interferon-beta	Interferon beta	Homo sapiens (human)
B cell proliferation	Interferon beta	Homo sapiens (human)
negative regulation of viral genome replication	Interferon beta	Homo sapiens (human)
innate immune response	Interferon beta	Homo sapiens (human)
positive regulation of innate immune response	Interferon beta	Homo sapiens (human)
regulation of MHC class I biosynthetic process	Interferon beta	Homo sapiens (human)
negative regulation of T cell differentiation	Interferon beta	Homo sapiens (human)
positive regulation of transcription by RNA polymerase II	Interferon beta	Homo sapiens (human)
defense response to virus	Interferon beta	Homo sapiens (human)
type I interferon-mediated signaling pathway	Interferon beta	Homo sapiens (human)
neuron cellular homeostasis	Interferon beta	Homo sapiens (human)
cellular response to exogenous dsRNA	Interferon beta	Homo sapiens (human)
cellular response to virus	Interferon beta	Homo sapiens (human)
negative regulation of Lewy body formation	Interferon beta	Homo sapiens (human)
negative regulation of T-helper 2 cell cytokine production	Interferon beta	Homo sapiens (human)
positive regulation of apoptotic signaling pathway	Interferon beta	Homo sapiens (human)
response to exogenous dsRNA	Interferon beta	Homo sapiens (human)
B cell differentiation	Interferon beta	Homo sapiens (human)
natural killer cell activation involved in immune response	Interferon beta	Homo sapiens (human)
adaptive immune response	Interferon beta	Homo sapiens (human)
T cell activation involved in immune response	Interferon beta	Homo sapiens (human)
humoral immune response	Interferon beta	Homo sapiens (human)
positive regulation of T cell mediated cytotoxicity	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
adaptive immune response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independent	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of T cell anergy	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
defense response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
immune response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
detection of bacterium	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of interleukin-12 production	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of interleukin-6 production	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
protection from natural killer cell mediated cytotoxicity	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
innate immune response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of dendritic cell differentiation	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class Ib	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
negative regulation of chronic inflammatory response	Aromatase	Homo sapiens (human)
steroid biosynthetic process	Aromatase	Homo sapiens (human)
estrogen biosynthetic process	Aromatase	Homo sapiens (human)
androgen catabolic process	Aromatase	Homo sapiens (human)
syncytium formation	Aromatase	Homo sapiens (human)
negative regulation of macrophage chemotaxis	Aromatase	Homo sapiens (human)
sterol metabolic process	Aromatase	Homo sapiens (human)
female genitalia development	Aromatase	Homo sapiens (human)
mammary gland development	Aromatase	Homo sapiens (human)
uterus development	Aromatase	Homo sapiens (human)
prostate gland growth	Aromatase	Homo sapiens (human)
testosterone biosynthetic process	Aromatase	Homo sapiens (human)
positive regulation of estradiol secretion	Aromatase	Homo sapiens (human)
female gonad development	Aromatase	Homo sapiens (human)
response to estradiol	Aromatase	Homo sapiens (human)
xenobiotic metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
steroid metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
cholesterol metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
estrogen metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
monoterpenoid metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
epoxygenase P450 pathway	Cytochrome P450 2C9	Homo sapiens (human)
urea metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
monocarboxylic acid metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
xenobiotic catabolic process	Cytochrome P450 2C9	Homo sapiens (human)
long-chain fatty acid biosynthetic process	Cytochrome P450 2C9	Homo sapiens (human)
amide metabolic process	Cytochrome P450 2C9	Homo sapiens (human)
icosanoid biosynthetic process	Cytochrome P450 2C9	Homo sapiens (human)
oxidative demethylation	Cytochrome P450 2C9	Homo sapiens (human)
omega-hydroxylase P450 pathway	Cytochrome P450 2C9	Homo sapiens (human)
bilirubin conjugation	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
heme catabolic process	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
cellular glucuronidation	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
vitamin D3 metabolic process	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
inositol phosphate metabolic process	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic process	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
negative regulation of cold-induced thermogenesis	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol phosphate biosynthetic process	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
xenobiotic metabolic process	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
xenobiotic transmembrane transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
negative regulation of gene expression	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
bile acid and bile salt transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
bilirubin transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
heme catabolic process	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
xenobiotic export from cell	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
transmembrane transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
transepithelial transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
leukotriene transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
monoatomic anion transmembrane transport	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
transport across blood-brain barrier	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
xenobiotic transport across blood-brain barrier	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
ATP binding	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ABC-type xenobiotic transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
glucuronoside transmembrane transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ABC-type bile acid transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ATP hydrolysis activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ATPase-coupled transmembrane transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
xenobiotic transmembrane transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
icosanoid transmembrane transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
ABC-type transporter activity	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
guanine nucleotide transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
protein binding	Multidrug resistance-associated protein 4	Homo sapiens (human)
ATP binding	Multidrug resistance-associated protein 4	Homo sapiens (human)
ABC-type xenobiotic transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
prostaglandin transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
urate transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
purine nucleotide transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
ABC-type bile acid transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
efflux transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
ATP hydrolysis activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
glutathione transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
ATPase-coupled transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
xenobiotic transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
ABC-type transporter activity	Multidrug resistance-associated protein 4	Homo sapiens (human)
protein binding	Bile salt export pump	Homo sapiens (human)
ATP binding	Bile salt export pump	Homo sapiens (human)
ABC-type xenobiotic transporter activity	Bile salt export pump	Homo sapiens (human)
bile acid transmembrane transporter activity	Bile salt export pump	Homo sapiens (human)
canalicular bile acid transmembrane transporter activity	Bile salt export pump	Homo sapiens (human)
carbohydrate transmembrane transporter activity	Bile salt export pump	Homo sapiens (human)
ABC-type bile acid transporter activity	Bile salt export pump	Homo sapiens (human)
ATP hydrolysis activity	Bile salt export pump	Homo sapiens (human)
cytokine activity	Interferon beta	Homo sapiens (human)
cytokine receptor binding	Interferon beta	Homo sapiens (human)
type I interferon receptor binding	Interferon beta	Homo sapiens (human)
protein binding	Interferon beta	Homo sapiens (human)
chloramphenicol O-acetyltransferase activity	Interferon beta	Homo sapiens (human)
TAP binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
signaling receptor binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
protein binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
peptide antigen binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
TAP binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
protein-folding chaperone binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
iron ion binding	Aromatase	Homo sapiens (human)
steroid hydroxylase activity	Aromatase	Homo sapiens (human)
electron transfer activity	Aromatase	Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygen	Aromatase	Homo sapiens (human)
oxygen binding	Aromatase	Homo sapiens (human)
heme binding	Aromatase	Homo sapiens (human)
aromatase activity	Aromatase	Homo sapiens (human)
monooxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
iron ion binding	Cytochrome P450 2C9	Homo sapiens (human)
arachidonic acid epoxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
steroid hydroxylase activity	Cytochrome P450 2C9	Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
oxidoreductase activity	Cytochrome P450 2C9	Homo sapiens (human)
(S)-limonene 6-monooxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
(S)-limonene 7-monooxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
caffeine oxidase activity	Cytochrome P450 2C9	Homo sapiens (human)
(R)-limonene 6-monooxygenase activity	Cytochrome P450 2C9	Homo sapiens (human)
aromatase activity	Cytochrome P450 2C9	Homo sapiens (human)
heme binding	Cytochrome P450 2C9	Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygen	Cytochrome P450 2C9	Homo sapiens (human)
retinoic acid binding	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
glucuronosyltransferase activity	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
enzyme binding	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
protein homodimerization activity	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
protein heterodimerization activity	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol heptakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate 5-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
protein binding	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
ATP binding	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate 1-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate 3-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
protein binding	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ATP binding	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
organic anion transmembrane transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ABC-type xenobiotic transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
bilirubin transmembrane transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ATP hydrolysis activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ATPase-coupled transmembrane transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
xenobiotic transmembrane transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
ABC-type transporter activity	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
plasma membrane	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
basal plasma membrane	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
basolateral plasma membrane	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
membrane	ATP-binding cassette sub-family C member 3	Homo sapiens (human)
nucleolus	Multidrug resistance-associated protein 4	Homo sapiens (human)
Golgi apparatus	Multidrug resistance-associated protein 4	Homo sapiens (human)
plasma membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
basolateral plasma membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
apical plasma membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
platelet dense granule membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
external side of apical plasma membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
plasma membrane	Multidrug resistance-associated protein 4	Homo sapiens (human)
basolateral plasma membrane	Bile salt export pump	Homo sapiens (human)
Golgi membrane	Bile salt export pump	Homo sapiens (human)
endosome	Bile salt export pump	Homo sapiens (human)
plasma membrane	Bile salt export pump	Homo sapiens (human)
cell surface	Bile salt export pump	Homo sapiens (human)
apical plasma membrane	Bile salt export pump	Homo sapiens (human)
intercellular canaliculus	Bile salt export pump	Homo sapiens (human)
intracellular canaliculus	Bile salt export pump	Homo sapiens (human)
recycling endosome	Bile salt export pump	Homo sapiens (human)
recycling endosome membrane	Bile salt export pump	Homo sapiens (human)
extracellular exosome	Bile salt export pump	Homo sapiens (human)
membrane	Bile salt export pump	Homo sapiens (human)
extracellular space	Interferon beta	Homo sapiens (human)
extracellular region	Interferon beta	Homo sapiens (human)
Golgi membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
endoplasmic reticulum	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
Golgi apparatus	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
plasma membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
cell surface	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
ER to Golgi transport vesicle membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
secretory granule membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
phagocytic vesicle membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
early endosome membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
recycling endosome membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
extracellular exosome	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
lumenal side of endoplasmic reticulum membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
MHC class I protein complex	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
extracellular space	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
external side of plasma membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
endoplasmic reticulum	Aromatase	Homo sapiens (human)
endoplasmic reticulum membrane	Aromatase	Homo sapiens (human)
membrane	Aromatase	Homo sapiens (human)
endoplasmic reticulum	Aromatase	Homo sapiens (human)
endoplasmic reticulum membrane	Cytochrome P450 2C9	Homo sapiens (human)
plasma membrane	Cytochrome P450 2C9	Homo sapiens (human)
intracellular membrane-bounded organelle	Cytochrome P450 2C9	Homo sapiens (human)
cytoplasm	Cytochrome P450 2C9	Homo sapiens (human)
intracellular membrane-bounded organelle	Cytochrome P450 2C9	Homo sapiens (human)
endoplasmic reticulum	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
endoplasmic reticulum membrane	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
endoplasmic reticulum	UDP-glucuronosyltransferase 1A4	Homo sapiens (human)
virion membrane	Spike glycoprotein	Severe acute respiratory syndrome-related coronavirus
fibrillar center	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
nucleoplasm	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
cytosol	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
nucleus	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
cytoplasm	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
plasma membrane	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
cell surface	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
apical plasma membrane	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
intercellular canaliculus	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
apical plasma membrane	Canalicular multispecific organic anion transporter 1	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID1296008	Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening	2020	SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1	Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347114	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347121	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425	Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)	2019	The Journal of biological chemistry, 11-15, Volume: 294, Issue:46	Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347124	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347126	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083	qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen	2020	Antiviral research, 01, Volume: 173	A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347113	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347111	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424	RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)	2019	The Journal of biological chemistry, 11-15, Volume: 294, Issue:46	Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID651635	Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347116	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347128	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407	qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection	2020	ACS 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.
AID1347123	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347122	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154	Primary screen GU AMC qHTS for Zika virus inhibitors	2020	Proceedings 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.
AID1347086	qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal	2020	Antiviral research, 01, Volume: 173	A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347103	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082	qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal	2020	Antiviral research, 01, Volume: 173	A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347097	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347109	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630	Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay	2021	Cell reports, 04-27, Volume: 35, Issue:4	A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347104	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347127	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845	Primary qHTS for Inhibitors of ATXN expression
AID1347112	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1079935	Cytolytic 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]
AID1215879	Drug metabolism in human liver microsomes assessed as UGT1A4 -163G>A(GG) variant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1473741	Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay	2013	Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1	A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1215863	Drug metabolism assessed as hecogenin-mediated inhibition of human recombinant UGT1A4-catalyzed anastrozole glucuronidation at 5 uM after 90 mins	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1215861	Drug metabolism in pooled human liver microsomes assessed as IC50 for hecogenin-mediated inhibition of anastrozole glucuronidation after 90 mins	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID588214	FDA HLAED, liver enzyme composite activity	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1215858	Drug metabolism in human liver microsomes assessed as UGT1A4 -219C>T(TT) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID548925	Effect on circulating testosterone and dihydrotestosterone level in sc dosed Sprague-Dawley rat by radioimmunoassay relative to anastrozole	2010	European journal of medicinal chemistry, Dec, Volume: 45, Issue:12	Antimicrobial, antitumor and 5α-reductase inhibitor activities of some hydrazonoyl substituted pyrimidinones.
AID588219	FDA HLAED, gamma-glutamyl transferase (GGT) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588212	Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents	2010	Chemical research in toxicology, Jan, Volume: 23, Issue:1	Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1215865	Drug metabolism assessed as hecogenin-mediated inhibition of human recombinant UGT1A4-catalyzed anastrozole glucuronidation at 50 uM after 90 mins	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID625290	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID654681	Inhibition of aromatase	2012	Bioorganic & medicinal chemistry, Apr-15, Volume: 20, Issue:8	Development of a new class of aromatase inhibitors: design, synthesis and inhibitory activity of 3-phenylchroman-4-one (isoflavanone) derivatives.
AID1215881	Drug metabolism in human liver microsomes assessed as UGT1A4 -163G>A(AA) variant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1307752	Inhibition of aromatase (unknown origin) transfected in human MCF7 cells	2016	Journal of medicinal chemistry, 06-09, Volume: 59, Issue:11	Recent Progress in the Discovery of Next Generation Inhibitors of Aromatase from the Structure-Function Perspective.
AID1215867	Drug metabolism in human liver microsomes assessed as retention time at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID537737	Acute toxicity in sc dosed albino rat	2010	European journal of medicinal chemistry, Nov, Volume: 45, Issue:11	Synthesis of bioactive polyheterocyclic ring systems as 5α-reductase inhibitors.
AID625281	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1855795	Inhibition of aromatase in human breast tumor	2022	European journal of medicinal chemistry, Nov-05, Volume: 241	An overview on Estrogen receptors signaling and its ligands in breast cancer.
AID1079937	Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID625288	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1193496	Thermodynamic equilibrium solubility, log S of the compound in water at RT after 24 hrs by shake-flask method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1193495	Thermodynamic equilibrium solubility, log S of the compound in simulated intestinal fluid at pH 6.8 at RT after 4 hrs by 96 well plate method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1079938	Chronic 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]
AID1079936	Choleostatic 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]
AID1079945	Animal toxicity known. [column 'TOXIC' in source]
AID1249548	Inhibition of aromatase (unknown origin)	2015	Journal of medicinal chemistry, Oct-08, Volume: 58, Issue:19	Discovery and Development of the Aryl O-Sulfamate Pharmacophore for Oncology and Women's Health.
AID588218	FDA HLAED, lactate dehydrogenase (LDH) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1473738	Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay	2013	Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1	A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1215864	Drug metabolism assessed as hecogenin-mediated inhibition of human recombinant UGT1A4-catalyzed anastrozole glucuronidation after 90 mins	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1215859	Drug metabolism in human liver microsomes assessed as glucuronide formation per mg protein by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID548924	Effect on circulating testosterone and dihydrotestosterone level in sc dosed Sprague-Dawley rat by radioimmunoassay	2010	European journal of medicinal chemistry, Dec, Volume: 45, Issue:12	Antimicrobial, antitumor and 5α-reductase inhibitor activities of some hydrazonoyl substituted pyrimidinones.
AID1215883	Drug metabolism in human liver microsomes assessed as UGT1A4 -217T>G(TG) variant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID282900	Inhibition of human placental microsome CYP19	2005	Journal of medicinal chemistry, Nov-17, Volume: 48, Issue:23	Enantioselective nonsteroidal aromatase inhibitors identified through a multidisciplinary medicinal chemistry approach.
AID588217	FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079948	Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1215857	Drug metabolism in human liver microsomes assessed as UGT1A4 -219C>T(CT) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID588215	FDA HLAED, alkaline phosphatase increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588216	FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1215875	Drug metabolism in human liver microsomes assessed as UGT1A4 142T>G (GG) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1215876	Drug metabolism in human liver microsomes assessed as UGT1A4 -36G>A (GG) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID259900	Cytotoxicity in rat hepatocytes at 100 uM after 24 hrs exposure	2006	Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3	Potent CYP19 (aromatase) 1-[(benzofuran-2-yl)(phenylmethyl)pyridine, -imidazole, and -triazole inhibitors: synthesis and biological evaluation.
AID259894	Displacement of [1,2,6,7-3H]-androstenedione from human placental CYP19	2006	Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3	Potent CYP19 (aromatase) 1-[(benzofuran-2-yl)(phenylmethyl)pyridine, -imidazole, and -triazole inhibitors: synthesis and biological evaluation.
AID1473740	Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay	2013	Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1	A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1474166	Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index	2016	Drug 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.
AID1079947	Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1193498	Thermodynamic equilibrium solubility, log S of the compound simulated gastric fluid at pH 1.2 at RT after 24 hrs by shake-flask method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID625286	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID461812	Inhibition of steroid sulfatase in human JEG3 cells by scintillation spectrometry	2010	Journal of medicinal chemistry, Mar-11, Volume: 53, Issue:5	Highly potent first examples of dual aromatase-steroid sulfatase inhibitors based on a biphenyl template.
AID1079942	Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1193492	Thermodynamic equilibrium solubility, log S of the compound in water at RT after 4 hrs by 96 well plate method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID548923	Acute toxicity in albino rat	2010	European journal of medicinal chemistry, Dec, Volume: 45, Issue:12	Antimicrobial, antitumor and 5α-reductase inhibitor activities of some hydrazonoyl substituted pyrimidinones.
AID1215880	Drug metabolism in human liver microsomes assessed as UGT1A4 -163G>A(AG) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1193493	Thermodynamic equilibrium solubility, log S of the compound in PBS at pH 7.4 at RT after 4 hrs by 96 well plate method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1079946	Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079949	Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID625280	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1193494	Thermodynamic equilibrium solubility, log S of the compound in simulated gastric fluid at pH 1.2 at RT after 4 hrs by 96 well plate method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1215882	Drug metabolism in human liver microsomes assessed as UGT1A4 -217T>G(TT) variant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID625292	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID479369	Inhibition of human placental microsome CYP19	2010	Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10	Pharmacophore modeling strategies for the development of novel nonsteroidal inhibitors of human aromatase (CYP19).
AID625285	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625287	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID366344	Inhibition of aromatase in human placental microsomes	2008	Bioorganic & medicinal chemistry letters, Aug-15, Volume: 18, Issue:16	Synthesis of 6- or 4-functionalized indoles via a reductive cyclization approach and evaluation as aromatase inhibitors.
AID1079940	Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID650843	Competitive inhibition of human aromatase using dibenzylfluorescein substrate after 10 mins preincubation measured every 10 sec for 5 mins by Michaelis-Menten and Dixon plot analysis	2012	Bioorganic & medicinal chemistry, Apr-01, Volume: 20, Issue:7	Optimization of the aromatase inhibitory activities of pyridylthiazole analogues of resveratrol.
AID1215862	Drug metabolism in pooled human liver microsomes assessed as hecogenin-mediated inhibition of anastrozole glucuronidation at 50 uM after 90 mins	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID468984	Inhibition of human 17beta-HSD7 expressed in HEK293 cells assessed as inhibition of reduction of [14C]estrone into [14C]estradiol at 0.3 uM after 7 hrs	2009	Journal of medicinal chemistry, Dec-10, Volume: 52, Issue:23	Potent and selective steroidal inhibitors of 17beta-hydroxysteroid dehydrogenase type 7, an enzyme that catalyzes the reduction of the key hormones estrone and dihydrotestosterone.
AID1079934	Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID468985	Inhibition of human 17beta-HSD7 expressed in HEK293 cells assessed as inhibition of reduction of [14C]estrone into [14C]estradiol at 3 uM after 7 hrs	2009	Journal of medicinal chemistry, Dec-10, Volume: 52, Issue:23	Potent and selective steroidal inhibitors of 17beta-hydroxysteroid dehydrogenase type 7, an enzyme that catalyzes the reduction of the key hormones estrone and dihydrotestosterone.
AID1215877	Drug metabolism in human liver microsomes assessed as UGT1A4 -36G>A (AG) variant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID461809	Inhibition of aromatase in human JEG3 cells by scintillation spectrometry	2010	Journal of medicinal chemistry, Mar-11, Volume: 53, Issue:5	Highly potent first examples of dual aromatase-steroid sulfatase inhibitors based on a biphenyl template.
AID1079941	Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID259901	Ratio of LC50/IC50	2006	Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3	Potent CYP19 (aromatase) 1-[(benzofuran-2-yl)(phenylmethyl)pyridine, -imidazole, and -triazole inhibitors: synthesis and biological evaluation.
AID1215870	Drug metabolism in human liver microsomes assessed as UGT1A4 70C>A (AC) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1474167	Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status	2016	Drug 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.
AID650842	Inhibition of human aromatase using dibenzylfluorescein substrate preincubated for 30 mins measured after 30 mins by fluorescence assay	2012	Bioorganic & medicinal chemistry, Apr-01, Volume: 20, Issue:7	Optimization of the aromatase inhibitory activities of pyridylthiazole analogues of resveratrol.
AID1215860	Drug metabolism in pooled human liver microsomes assessed as hecogenin-mediated inhibition of anastrozole glucuronidation at 5 uM after 90 mins	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID625284	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1215856	Drug metabolism in human liver microsomes assessed as UGT1A4 -219C>T(CC) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1079931	Moderate 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]
AID1079939	Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1215871	Drug metabolism in human liver microsomes assessed as UGT1A4 70C>A (CC) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1215874	Drug metabolism in human liver microsomes assessed as UGT1A4 142T>G (TG) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID537738	Inhibition of 5-alpha-reductase activity in sc dosed Sprague-Dawley rat assessed as effect on serum steroid level administered on postnatal third day measured after 7 weeks of age by radioimmunoassay	2010	European journal of medicinal chemistry, Nov, Volume: 45, Issue:11	Synthesis of bioactive polyheterocyclic ring systems as 5α-reductase inhibitors.
AID1215855	Drug metabolism in human liver microsomes assessed as UGT1A4 -217T>G(GG) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID1079932	Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1193497	Thermodynamic equilibrium solubility, log S of the compound PBS at pH 7.4 at RT after 24 hrs by shake-flask method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID625282	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473739	Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay	2013	Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1	A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID588211	Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans	2010	Chemical research in toxicology, Jan, Volume: 23, Issue:1	Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625289	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079933	Acute 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
AID1215878	Drug metabolism in human liver microsomes assessed as UGT1A4 -36G>A (AA) variant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID625291	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1215872	Drug metabolism in human liver microsomes assessed as UGT1A4 70C>A (AA) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID588213	Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents	2010	Chemical research in toxicology, Jan, Volume: 23, Issue:1	Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625279	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1390538	Inhibition of aromatase (unknown origin)	2018	Bioorganic & medicinal chemistry, 05-01, Volume: 26, Issue:8	Studies on non-steroidal inhibitors of aromatase enzyme; 4-(aryl/heteroaryl)-2-(pyrimidin-2-yl)thiazole derivatives.
AID1079944	Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079943	Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID311524	Oral bioavailability in human	2007	Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24	Hologram QSAR model for the prediction of human oral bioavailability.
AID1193499	Thermodynamic equilibrium solubility, log S of the compound simulated intestinal fluid at pH 6.8 at RT after 24 hrs by shake-flask method	2015	Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7	Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1215873	Drug metabolism in human liver microsomes assessed as UGT1A4 142T>G (TT) mutant-mediated compound glucuronidation at 100 uM by mass spectrometry analysis	2013	Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4	Potential role of UGT1A4 promoter SNPs in anastrozole pharmacogenomics.
AID504810	Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812	Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1346986	P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987	P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID504749	qHTS profiling for inhibitors of Plasmodium falciparum proliferation	2011	Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043	Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1347411	qHTS 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) Libary	2020	ACS 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.
AID1159607	Screen for inhibitors of RMI FANCM (MM2) intereaction	2016	Journal 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.
AID1796387	Aromatase Assay from Article 10.1021/jm0508282: \\Potent CYP19 (aromatase) 1-[(benzofuran-2-yl)(phenylmethyl)pyridine, -imidazole, and -triazole inhibitors: synthesis and biological evaluation.\\	2006	Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3	Potent CYP19 (aromatase) 1-[(benzofuran-2-yl)(phenylmethyl)pyridine, -imidazole, and -triazole inhibitors: synthesis and biological evaluation.
AID1799682	Aromatase Assay from Article 10.1080/14756360400015256: \\Benzofuran- and furan-2-yl-(phenyl)-3-pyridylmethanols: synthesis and inhibition of P450 aromatase.\\	2005	Journal of enzyme inhibition and medicinal chemistry, Apr, Volume: 20, Issue:2	Benzofuran- and furan-2-yl-(phenyl)-3-pyridylmethanols: synthesis and inhibition of P450 aromatase.
AID1345280	Human CYP19A1 (CYP11, CYP17, CYP19, CYP20 and CYP21 families)	2010	Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10	Pharmacophore modeling strategies for the development of novel nonsteroidal inhibitors of human aromatase (CYP19).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	6 (0.40)	18.7374
1990's	63 (4.23)	18.2507
2000's	651 (43.75)	29.6817
2010's	623 (41.87)	24.3611
2020's	145 (9.74)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	354 (22.58%)	5.53%
Reviews	308 (19.64%)	6.00%
Case Studies	192 (12.24%)	4.05%
Observational	6 (0.38%)	0.25%
Other	708 (45.15%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (309)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Open-label Study of First Line Pyrotinib, Trastuzumab With an Aromatase Inhibitors, in the Treatment of HER2 Positive and HR Positive Metastatic or Inoperable Locally Advanced Breast Cancer [NCT03910712]	Phase 2	250 participants (Anticipated)	Interventional	2019-06-01	Not yet recruiting
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy [NCT00053898]	Phase 3	3,104 participants (Actual)	Interventional	2003-01-31	Completed
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance [NCT01197170]	Phase 1	277 participants (Actual)	Interventional	2010-09-07	Completed
A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Recep [NCT00274469]	Phase 2	205 participants (Actual)	Interventional	2006-02-06	Completed
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Tr [NCT01272037]	Phase 3	5,018 participants (Actual)	Interventional	2011-01-15	Active, not recruiting
A Phase II Clinical Trial Evaluating the Combination of Onapristone With Anastrozole for Women With Refractory Hormone Receptor Positive Endometrial Cancer [NCT04719273]	Phase 2	14 participants (Actual)	Interventional	2021-01-28	Active, not recruiting
Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer [NCT01262274]	Phase 2	57 participants (Actual)	Interventional	2010-12-31	Terminated(stopped due to Due to an adverse event revelation.)
An Open Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two Period, Crossover, Single Dose Comparative Oral Bioavailability Study Of Anastrozole Tablets 1 mg (Test) Of Dr. Reddy's Laboratories Ltd., India And ARIMIDEX® Tablets 1 mg (Reference) Of [NCT01155960]	Phase 1	36 participants (Actual)	Interventional	2008-05-31	Completed
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fasting Conditions [NCT01155102]		31 participants (Actual)	Interventional	2006-04-30	Completed
Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW [NCT03768258]		1,268 participants (Actual)	Observational	2008-03-31	Completed
Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole [NCT04075604]	Phase 2	23 participants (Actual)	Interventional	2019-10-18	Completed
An Open Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two Period, Crossover, Single Dose Comparative Oral Bioavailability Study Of Anastrozole Tablets 1 mg (Test) Of Dr. Reddy's Laboratories Ltd., India And ARIMIDEX® Tablets 1 mg (Reference) Of [NCT01155947]	Phase 1	36 participants (Actual)	Interventional	2008-05-31	Completed
Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer [NCT01127295]	Phase 4	2,000 participants (Actual)	Interventional	2010-06-17	Completed
Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture [NCT03925233]		300 participants (Anticipated)	Observational	2019-01-02	Enrolling by invitation
Randomized Phase II Study OF Goserelin (G) Plus Fulvestrant (F) vs. G Plus Anastrozole (A)vs. G Alone for HR+, Tamoxifen Pretreated, Premenopausal Woman [NCT01266213]	Phase 2	147 participants (Anticipated)	Interventional	2010-12-31	Active, not recruiting
Phase II Randomized, Multicenter, Crossover Clinical Trial for Administration of Exemestane vs. Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer [NCT00128843]	Phase 2	103 participants (Actual)	Interventional	2001-08-31	Completed
The Study of Goserelin Plus Fulvestrant Comparing With Goserelin Plus Anastrozole for Advanced Breast Cancer [NCT02072512]	Phase 2	180 participants (Anticipated)	Interventional	2014-01-31	Recruiting
DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study [NCT06075953]	Phase 2	400 participants (Anticipated)	Interventional	2023-11-30	Recruiting
A Phase 1 Trial of MK-2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer [NCT01344031]	Phase 1	31 participants (Actual)	Interventional	2011-04-21	Completed
A Randomised, Open Label, Single Centre, 2 Way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects [NCT01568281]	Phase 1	58 participants (Actual)	Interventional	2012-04-30	Completed
FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in Firs [NCT00256698]	Phase 3	514 participants (Actual)	Interventional	2004-01-31	Completed
A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer [NCT00143390]	Phase 3	298 participants (Actual)	Interventional	2005-04-30	Completed
An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis [NCT00094328]	Phase 2	14 participants (Actual)	Interventional	2004-11-22	Completed
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer [NCT00075764]	Phase 3	695 participants (Actual)	Interventional	2004-04-30	Completed
Bioequivalence Study of CJ Anastrozole 1mg Tablet and Arimidex® 1 mg Tablet [NCT01105299]		24 participants (Actual)	Interventional	2008-06-30	Completed
A Multicentric, Randomized, Non Comparative, Open-label Phase I/II Evaluating AZD2014 (Dual Mammalian Target of Rapamycin Complex 1/2 (mTORC1/mTORC2) Inhibitor) in Combination With Anastrozole Versus Anastrozole Alone in the Treatment of Metastatic Hormon [NCT02730923]	Phase 1/Phase 2	72 participants (Anticipated)	Interventional	2016-04-30	Active, not recruiting
A Phase 3 Randomized Controlled Study of Metronomic Capecitabine Combined With Aromatase Inhibitor Versus Aromatase Inhibitor Alone for First Line Treatment in Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer [NCT02767661]	Phase 3	240 participants (Anticipated)	Interventional	2017-07-19	Active, not recruiting
Phase III Trial Comparing Efficacy and Tolerance of Fulvestrant for 3 Years (y) Combined With Anastrozole 5 y Versus Anastrozole 5 y as Adjuvant Hormonotherapy in Postmenopausal With Early Breast Cancer and Positive Hormone Receptors [NCT00543127]	Phase 3	870 participants (Actual)	Interventional	2007-11-30	Terminated(stopped due to Unjustified decision of company that funded the trial.)
A Randomized Phase 2 Clinical Trial to Evaluate the Activity of ATRA in Combination With Anastrozole in Pre-operative Phase of Operable HR-positive/HER2-negative Early Breast Cancer (ATRA) [NCT04113863]	Phase 2	112 participants (Anticipated)	Interventional	2019-06-18	Recruiting
Evaluation of Adjuvant Endocrine Therapy for Operable ER-beta Positive, ER-alpha/PR Negative, Her-2 Negative Breast Cancer Patients [NCT02089854]	Phase 4	800 participants (Anticipated)	Interventional	2014-11-30	Recruiting
An Open, Single-center, Exploratory Cohort Study of Chidamide in Combination With Endocrine in Maintenance Therapy After First-line Chemotherapy for HR+/HER2- Breast Cancer [NCT05890287]		60 participants (Anticipated)	Interventional	2023-05-16	Recruiting
Treatment of Canadian Men and Pre/Postmenopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy [NCT02753686]		440 participants (Actual)	Observational [Patient Registry]	2016-03-15	Completed
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) [NCT01824836]		1,046 participants (Actual)	Interventional	2013-06-11	Active, not recruiting
Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer [NCT02097459]	Phase 3	600 participants (Anticipated)	Interventional	2014-03-31	Recruiting
An Open-label, Multi-center, Randomized Phase II Study of Fulvestrant Anastrozole Combination Versus Anastrozole Alone in Patients With Luminal A-like Postmenopausal Advanced Breast Cancer [NCT02140437]	Phase 2	0 participants (Actual)	Interventional	2014-03-31	Withdrawn(stopped due to The progress of enrollment is too slow.)
A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer [NCT02206984]	Phase 2	201 participants (Anticipated)	Interventional	2015-09-30	Recruiting
Testosterone Regulation of the Natriuretic Peptide System [NCT02269072]		0 participants (Actual)	Interventional	2015-02-28	Withdrawn(stopped due to Lack of funding)
A Randomized Phase II Trial of Combination Anastrozole (NSC #719344) Plus ZD1839 (Iressa, NSC #715055, IND #61187) and of Combination Fulvestrant (NSC #719276) Plus ZD1839 in the Treatment of Postmenopausal Women With Hormone Receptor-Positive Metastatic [NCT00057941]	Phase 2	148 participants (Actual)	Interventional	2003-09-30	Completed
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk [NCT05514054]	Phase 3	6,000 participants (Anticipated)	Interventional	2022-10-04	Recruiting
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT) [NCT05238831]	Early Phase 1	25 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer [NCT04294225]	Phase 2	161 participants (Actual)	Interventional	2020-04-28	Completed
A Phase IB/II to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer [NCT03481998]	Phase 1/Phase 2	104 participants (Actual)	Interventional	2018-03-22	Completed
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fed Conditions [NCT01155089]		32 participants (Actual)	Interventional	2006-05-31	Completed
Safety of Ovarian Function Suppression(OFS)Combined With Different Aromatase Inhibitors(AIs) Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients：A Randomized, Controlled, Prospective, Observational Study [NCT02440230]	Phase 2	110 participants (Actual)	Interventional	2015-05-31	Completed
Multicenter, First-line Metastatic Open-label Prospective Phase II Trial Evaluating the Combination of Palbociclib (CDK 4/6 Inhibitor) and Hormone Therapy (Letrozole or Anastrozole) in Women With Luminal, HER2 Negative Advanced Breast Cancer: Evaluation o [NCT05190094]	Phase 2	80 participants (Anticipated)	Interventional	2022-12-20	Recruiting
An OptioExtension of Trial 1033US/0006 to Assess Safety, Tolerability, Efficacy of Anastrozole (ZD1033, Arimidex™) in Treatment of Gynecomastia in Pubertal Boys Given Placebo and to Conduct a Long-Term Safety Follow-Up of Non-Responding Subjects Given Ana [NCT00637182]	Phase 3	0 participants	Interventional	2001-01-31	Completed
Hydroxychloroquine (HCQ) in Combination With Abemaciclib and Endocrine Therapy in HR+/Her 2- Advanced Breast Cancer After a Lead in Dose Escalation Cohort of HCQ and Abemaciclib in Advanced Solid Tumors [NCT04316169]	Phase 1	0 participants (Actual)	Interventional	2021-10-21	Withdrawn(stopped due to Funding and PI leaving institution)
Pyrotinib Maleate Combined With Trastuzumab Plus Aromatase Inhibitor in the First-line Treatment of Advanced HER2-positive/HR-positive Breast Cancer Phase II Study [NCT04088110]	Phase 2	77 participants (Anticipated)	Interventional	2019-11-30	Not yet recruiting
A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies [NCT00661531]	Phase 2	11 participants (Actual)	Interventional	2008-04-30	Terminated(stopped due to Poor accrual)
Impact of Estradiol Addback on Somatostatin Rebound in Older Men [NCT01862835]	Phase 1	43 participants (Actual)	Interventional	2013-05-31	Completed
MAINtenance Afinitor: A Randomized Trial Comparing Maintenance Aromatase Inhibitors (AIs) + Everolimus (Afinitor) vs AIs in Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients With Disease Control After First Line Chemotherapy [NCT02511639]	Phase 3	110 participants (Actual)	Interventional	2014-07-30	Completed
A Phase III Study Comparing the Concurrent Versus the Sequential Administration of Chemotherapy and Aromatase Inhibitors, as Adjuvant Treatment of Post-menopausal Patients With Endocrine-responsive Early Breast Cancer. [NCT02918084]	Phase 3	1,000 participants (Anticipated)	Interventional	2013-06-30	Active, not recruiting
A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer [NCT05774951]	Phase 3	4,300 participants (Anticipated)	Interventional	2023-03-31	Recruiting
Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN) [NCT05472792]	Phase 2	90 participants (Anticipated)	Interventional	2022-05-17	Recruiting
SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have [NCT04711252]	Phase 3	1,342 participants (Anticipated)	Interventional	2021-01-28	Recruiting
A Single-Centre Pilot Trial Investigating the Efficacy and Safety of Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density [NCT03264651]	Phase 1	9 participants (Actual)	Interventional	2017-02-01	Completed
Anti-hormonal Maintenance Treatment With the CDK4/6 Inhibitor Ribociclib After 1st Line Chemotherapy in Hormone Receptor Positive / HER2 Negative Metastatic Breast Cancer: A Phase II Trial [NCT03555877]	Phase 2	56 participants (Actual)	Interventional	2018-03-15	Completed
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism [NCT03118479]	Phase 1	7 participants (Actual)	Interventional	2010-05-31	Terminated(stopped due to Because the PI left the institution.)
An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormo [NCT04059484]	Phase 2	363 participants (Actual)	Interventional	2019-10-22	Active, not recruiting
A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women [NCT00186121]	Phase 2	35 participants (Actual)	Interventional	2000-10-31	Completed
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer [NCT05896566]	Phase 2	220 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
A Randomized Trial, Phase IIIb, Open Label Study of Exemestane After Two to Three Years of Anastrozole/Letrozole Treatment of Postmenopausal Women With Hormone Receptor Positive Breast Cancer [NCT00902954]	Phase 3	540 participants (Anticipated)	Interventional	2008-03-31	Recruiting
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy [NCT00244959]	Phase 2	54 participants (Actual)	Interventional	2004-01-31	Completed
Assessment of Knee Joint Articular Cartilage Volume Change, Bone Loss and Change in Body Composition in Women Treated With Anastrozole or Letrozole and Comparison With Untreated Controls [NCT00111241]		115 participants (Actual)	Observational	2005-05-31	Completed
Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy. [NCT00935558]	Phase 2	0 participants (Actual)	Interventional	2009-07-31	Withdrawn(stopped due to no patients enrolled)
A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-st [NCT00944918]	Phase 3	25 participants (Actual)	Interventional	2008-12-31	Completed
Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer [NCT05524584]	Phase 2	20 participants (Anticipated)	Interventional	2022-08-31	Recruiting
A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Adv [NCT03839823]	Phase 2	223 participants (Actual)	Interventional	2019-02-25	Completed
A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopausal Women With Hormone Receptor Positive Breast Cancer [NCT00570323]	Phase 2	72 participants (Actual)	Interventional	2007-12-31	Completed
A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Posi [NCT02278120]	Phase 3	672 participants (Actual)	Interventional	2014-11-20	Completed
A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression [NCT00005908]	Phase 2	30 participants (Actual)	Interventional	2000-06-30	Completed
A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer [NCT00022672]	Phase 3	208 participants (Actual)	Interventional	2001-01-31	Completed
Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy [NCT06086704]	Phase 2	53 participants (Anticipated)	Interventional	2024-01-31	Recruiting
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy [NCT04258163]		760 participants (Actual)	Observational	2019-01-01	Completed
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer [NCT04272801]	Phase 2	83 participants (Anticipated)	Interventional	2020-04-07	Recruiting
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ [NCT04666961]	Phase 2	262 participants (Anticipated)	Interventional	2021-02-03	Recruiting
Randomized Phase II/III Study of Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic Estrogen Receptor Positive Breast Cancer [NCT00684216]	Phase 2/Phase 3	10 participants (Actual)	Interventional	2008-04-30	Terminated(stopped due to acrual too slow)
Phase II Randomized Study of Sorafenib Compared to Placebo When Administered in Combination With Aromatase Inhibitors for Postmenopausal Women With Metastatic Breast Cancer [NCT00573755]	Phase 2	4 participants (Actual)	Interventional	2007-12-31	Terminated(stopped due to lack of participant accrual)
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1) [NCT03616587]	Phase 1	386 participants (Anticipated)	Interventional	2018-10-11	Recruiting
A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Meta [NCT02947685]	Phase 3	496 participants (Anticipated)	Interventional	2017-06-21	Active, not recruiting
Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study [NCT05645536]	Phase 3	250 participants (Anticipated)	Interventional	2022-12-28	Enrolling by invitation
Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epiderma [NCT04906395]	Phase 3	250 participants (Anticipated)	Interventional	2021-07-01	Recruiting
A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Carcinoma [NCT02040857]	Phase 2	162 participants (Actual)	Interventional	2014-01-31	Completed
Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients [NCT03079011]	Phase 3	1,017 participants (Actual)	Interventional	2017-03-22	Active, not recruiting
Multi-centre, Randomised, Double-blind, Parallel-group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-operative Administration Under Goserelin Acetate Treatment for Premenopausal Breast Cancer Patients [NCT00605267]	Phase 3	197 participants (Actual)	Interventional	2007-10-31	Completed
Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI) [NCT00973505]		100 participants (Anticipated)	Observational	2009-03-31	Recruiting
PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breas [NCT03220178]	Phase 4	532 participants (Actual)	Interventional	2017-07-24	Terminated(stopped due to Due to COVID-19 pandemic, study cannot be finished in planned timeframe.)
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial [NCT03778931]	Phase 3	478 participants (Actual)	Interventional	2019-05-10	Active, not recruiting
Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study [NCT01016665]		71 participants (Actual)	Interventional	2005-04-30	Completed
A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer [NCT01402193]	Phase 3	220 participants (Anticipated)	Interventional	2011-07-31	Recruiting
Phase 2 Randomized, Multicenter Study of IMC-A12 as a Single Agent or in Combination With Antiestrogens in Postmenopausal Women With Hormone Receptor-Positive Advanced or Metastatic Breast Cancer After Progression on Antiestrogen Therapy [NCT00728949]	Phase 2	93 participants (Actual)	Interventional	2008-08-31	Completed
Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis [NCT00638391]		1,600 participants (Actual)	Observational	2005-05-31	Completed
PREDIX Luminal B - Neoadjuvant Response-guided Treatment of ER Positive Tumors With High Proliferation or Low Proliferation With Metastatic Nodes. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes [NCT02603679]	Phase 2	181 participants (Actual)	Interventional	2015-02-28	Active, not recruiting
A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study). [NCT00738777]	Phase 2	250 participants (Anticipated)	Interventional	2008-07-31	Suspended(stopped due to in preparation for an amendment)
A Randomised, Double Blind Trial to Assess the Incidence of Endometrial Changes With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women [NCT00814125]	Phase 3	285 participants (Actual)	Interventional	1997-06-30	Completed
ARimidex Therapy Compliance Electronic MonitorIng System. A Study to Evaluate the Impact of Educational Material on the Adherence to Treatment With Adjuvant Anastrozole for Postmenopausal Women With Hormone Sensitive Early Breast Cancer [NCT00936442]		104 participants (Actual)	Observational	2009-06-30	Completed
Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor [NCT05780567]	Phase 3	1,946 participants (Anticipated)	Interventional	2023-03-30	Recruiting
ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer) [NCT00562458]		200 participants (Actual)	Observational	2006-12-31	Completed
An Open-label, Randomized, Non-comparative Phase 2 Study of ARV-471 or Anastrozole in Post-menopausal Women With ER+/HER2- Breast Cancer in the Neoadjuvant Setting [NCT05549505]	Phase 2	150 participants (Anticipated)	Interventional	2023-02-15	Recruiting
Pilot Trial of Anastrozole and Palbociclib as First-Line Therapy and as Maintenance Therapy After First Line Chemotherapy in Hormone Receptor Positive, HER2-Negative Postmenopausal Metastatic Breast Cancer [NCT02942355]	Phase 2	40 participants (Anticipated)	Interventional	2016-12-07	Active, not recruiting
A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer. [NCT00893061]	Phase 3	60 participants (Anticipated)	Interventional	2009-02-28	Recruiting
Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men [NCT00983554]		57 participants (Actual)	Interventional	2005-06-30	Active, not recruiting
Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of [NCT00871858]	Phase 2	120 participants (Actual)	Interventional	2008-03-18	Completed
A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women [NCT00784680]	Phase 3	308 participants (Actual)	Interventional	1998-04-30	Completed
NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer [NCT05837455]	Phase 2	81 participants (Anticipated)	Interventional	2023-11-30	Not yet recruiting
A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer [NCT00323479]	Phase 4	114 participants (Actual)	Interventional	2006-06-30	Completed
[NCT02765373]		500 participants (Anticipated)	Observational	2015-01-31	Enrolling by invitation
A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women [NCT00784862]	Phase 3	9,358 participants (Actual)	Interventional	1998-06-30	Completed
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) When Used as Adjuvant Treatment for Breast Cancer [NCT00784940]	Phase 3	308 participants (Actual)	Interventional	1998-06-30	Completed
Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men Title Changed With New Protocol (12/14/09): Hormonal Regulation of HDL-C in Men [NCT00729859]	Phase 2	31 participants (Actual)	Interventional	2008-12-31	Completed
A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study [NCT05161195]	Phase 4	137 participants (Anticipated)	Interventional	2022-07-07	Recruiting
Phase 2,Open-label,Multicenter,Randomized Study of PD0332991 (Oral CDK4/6 Inhibitor) Monotherapy and in Combination With the HT to Which the pt Has Progressed in the Previous Line for ER+,Her2- Post-menopausal Advanced Breast Cancer Pts [NCT02549430]	Phase 2	115 participants (Actual)	Interventional	2012-10-31	Completed
The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer [NCT06001762]	Phase 2	90 participants (Anticipated)	Interventional	2024-02-29	Recruiting
A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer [NCT00849030]	Phase 3	9,358 participants (Actual)	Interventional	1996-07-31	Completed
A Parallel Group, Randomized, Open-label Study to Investigate the Effect of the Intravaginally Administered Antimycotic Miconazole, Antibiotic Clindamycin, Spermicide Nonoxynol-9, or Co-usage of Tampons on 3 Consecutive Days on the Pharmacokinetics of Ana [NCT02545452]	Phase 1	52 participants (Actual)	Interventional	2015-09-15	Completed
A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer [NCT00265759]	Phase 3	622 participants (Actual)	Interventional	2006-01-31	Completed
Phase II Randomized, Double-blind, Placebo-controlled Study of LEE011(Ribociclib) or Placebo in Combination With Endocrine Therapy for the Treatment of Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer, Includin [NCT03671330]	Phase 2	327 participants (Actual)	Interventional	2018-08-29	Active, not recruiting
GCC 0927 A Pilot and Phase II Study of Entinostat and Anastrozole/Tamoxifen in Women With Triple Negative Breast Cancer to Evaluate Biomarkers and Surrogates for Response [NCT01234532]	Phase 2	5 participants (Actual)	Interventional	2010-10-31	Terminated(stopped due to low accrual)
A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer [NCT03966898]	Phase 3	426 participants (Anticipated)	Interventional	2019-07-19	Active, not recruiting
The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men [NCT00104572]	Phase 2	44 participants (Actual)	Interventional	2004-03-31	Completed
A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow [NCT00357110]	Phase 2	13 participants (Actual)	Interventional	2006-04-30	Completed
A Prospective, Randomized, Open, Multicentre Phase III-study to Assess the Efficacy of Secondary Adjuvant Endocrine Anastrozole Therapy for 2 Further Yrs vs 5 Further Yrs in Patients With HR +ve Breast Cancer After 5-yr Primary Adjuvant Endocrine Therapy [NCT00295620]	Phase 3	3,484 participants (Actual)	Interventional	2004-03-01	Completed
GCC 1366: A Prospective Study of Neoadjuvant Non-Steroidal Aromatase Inhibitors to Evaluate Anti-Proliferative Response in Obese and Overweight Patients [NCT02095184]		90 participants (Anticipated)	Interventional	2015-05-25	Recruiting
A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients Wi [NCT04556773]	Phase 1	139 participants (Actual)	Interventional	2020-12-17	Active, not recruiting
Arimidex/Faslodex/Iressa Study: A Phase II Trial of Primary Systemic Therapy Using a Combination of Arimidex, Faslodex and Iressa (Gefitinib) in Postmenopausal Women With Hormone Receptor Positive Breast Cancer [NCT00206414]	Phase 2	15 participants (Actual)	Interventional	2003-01-31	Terminated(stopped due to Difficulty accruing subjects the study accrual was closed)
The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes [NCT01972984]	Phase 2	20 participants (Actual)	Interventional	2012-10-31	Completed
A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer [NCT01723774]	Phase 2	84 participants (Actual)	Interventional	2013-04-10	Active, not recruiting
A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex™) With or Without Concomitant Anastrozole (Arimidex™) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non- [NCT00253422]	Phase 3	750 participants (Anticipated)	Interventional	2004-03-31	Active, not recruiting
Impact of Endogenous Estrogen on Somatostatin Inhibition and Growth Hormone Rebound in Older Women [NCT02026973]	Phase 1	62 participants (Actual)	Interventional	2014-03-31	Completed
Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure [NCT00555477]	Phase 2	69 participants (Actual)	Interventional	2007-08-31	Terminated(stopped due to The study was stopped after 69 subjects were enrolled because of poor accrual.)
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer [NCT06179303]	Phase 2	60 participants (Anticipated)	Interventional	2024-06-01	Not yet recruiting
A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of AZD8931 In Combination With Anastrozole, Compared to Anastrozole Alone, in Post Menopausal Women With Hormone Receptor Positive, Endocrine Th [NCT01151215]	Phase 2	482 participants (Actual)	Interventional	2010-06-30	Terminated(stopped due to Futility)
Analysis of Gene Expression Following Short Term Exposure to Neoadjuvant Endocrine Therapy in Invasive Breast Cancer [NCT00588003]	Phase 1	45 participants (Actual)	Interventional	2004-03-31	Completed
Comparison of Anastrozole and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism [NCT00179517]	Phase 2	40 participants (Actual)	Interventional	2001-06-30	Completed
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fasting Conditions [NCT01182181]	Phase 1	22 participants (Actual)	Interventional	2005-08-31	Completed
A Phase 1b Study of Abemaciclib in Combination With Therapies for Patients With Metastatic Breast Cancer [NCT02057133]	Phase 1	198 participants (Anticipated)	Interventional	2014-03-10	Active, not recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With [NCT02763566]	Phase 3	463 participants (Actual)	Interventional	2016-12-05	Active, not recruiting
Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy [NCT03179904]	Phase 2	80 participants (Anticipated)	Interventional	2017-08-03	Recruiting
A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer [NCT00537771]	Phase 4	384 participants (Actual)	Interventional	2007-09-30	Completed
Randomised Phase II Study of Metronomic Chemotherapy Plus the Same Aromatase Inhibitor Compared to Metronomic Chemotherapy Alone in Women With Hormone Receptor Positive, Her-2 Non-Overexpressing Advanced Breast Cancer Whose Disease Has Progressed While Re [NCT00687648]	Phase 2	70 participants (Anticipated)	Interventional	2008-05-31	Recruiting
Overcoming Endocrine Resistance in Metastatic Breast Cancer: A Randomized Trial With Factorial Design Comparing Fulvestrant ± Lapatinib ± Aromatase Inhibitor in Metastatic Breast Cancer Progressing After Aromatase Inhibitor Therapy [NCT00688194]	Phase 3	396 participants (Anticipated)	Interventional	2008-05-31	Recruiting
CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Tre [NCT05952557]	Phase 3	5,500 participants (Anticipated)	Interventional	2023-10-05	Recruiting
A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutati [NCT04964934]	Phase 3	300 participants (Anticipated)	Interventional	2021-06-30	Recruiting
A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer. [NCT00635713]	Phase 3	588 participants (Anticipated)	Interventional	1997-05-31	Completed
A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disea [NCT02730091]	Phase 3	98 participants (Actual)	Interventional	2016-02-24	Terminated
A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER-Positive, HER2-Positive Breast Cancer. [NCT04236310]	Phase 2	37 participants (Anticipated)	Interventional	2020-01-15	Not yet recruiting
A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women. [NCT00629616]	Phase 2	116 participants (Actual)	Interventional	2007-10-31	Completed
Breast Cancer Tumor Care Patient Observation Programme [NCT00660244]		150 participants (Actual)	Observational	2008-02-29	Completed
The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer [NCT00681928]		72 participants (Actual)	Observational	2007-10-31	Completed
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fed Conditions [NCT01183390]	Phase 1	22 participants (Actual)	Interventional	2005-09-30	Completed
A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) [NCT02689921]	Phase 2	7 participants (Actual)	Interventional	2016-04-30	Active, not recruiting
[NCT00437853]		30 participants	Interventional	2003-06-30	Completed
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years With Luminal A-like Early Stage Breast Cancer (EUROPA): a Randomized Phase 3 Trial [NCT04134598]	Phase 3	926 participants (Anticipated)	Interventional	2021-02-08	Recruiting
A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER [NCT03822468]	Phase 2	376 participants (Actual)	Interventional	2019-06-11	Active, not recruiting
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 2	94 participants (Anticipated)	Interventional	2006-10-31	Active, not recruiting
A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer [NCT00217659]	Phase 2	0 participants (Actual)	Interventional	2005-09-30	Withdrawn(stopped due to poor accrual)
A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer [NCT00544986]	Phase 4	0 participants	Interventional	2005-06-30	Completed
Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide). [NCT01769781]	Phase 4	70 participants (Actual)	Interventional	2013-01-31	Completed
Anastrozole Administration in Elderly Hypogonadal Men [NCT00136695]	Phase 2	88 participants (Actual)	Interventional	2004-10-31	Completed
A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales [NCT03933618]	Phase 2	24 participants (Actual)	Interventional	2015-04-02	Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregional [NCT02246621]	Phase 3	493 participants (Actual)	Interventional	2014-11-06	Active, not recruiting
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial [NCT00310180]	Phase 3	10,273 participants (Actual)	Interventional	2006-04-07	Active, not recruiting
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome [NCT00438321]	Phase 1	66 participants (Actual)	Interventional	2006-09-30	Terminated(stopped due to PI relocated)
A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer [NCT04852887]	Phase 3	1,670 participants (Anticipated)	Interventional	2021-06-07	Recruiting
A Multicenter, Phase I/II Trial of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast Cancer [NCT03304080]	Phase 1/Phase 2	44 participants (Actual)	Interventional	2017-12-20	Active, not recruiting
A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer [NCT02585388]	Phase 2	120 participants (Actual)	Interventional	2015-10-23	Terminated(stopped due to Treatment toxicity)
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast: A Multicenter, Retrospective, Real-world Study [NCT04666805]		1,354 participants (Anticipated)	Observational	2020-07-01	Active, not recruiting
A Phase III Study Comparing Anastrozole, Letrozole and Exemestane, Upfront (for 5 Years) or Sequentially (for 3 Years After 2 Years of Tamoxifen), as Adjuvant Treatment of Postmenopausal Patients With Endocrine-responsive Breast Cancer [NCT00541086]	Phase 3	3,697 participants (Actual)	Interventional	2007-03-31	Active, not recruiting
A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer [NCT02910050]	Phase 2	58 participants (Anticipated)	Interventional	2016-01-31	Recruiting
A Randomised in Practice Evaluation of the Influence of Patient's Understanding of Her Disease and Therapy on Persistence and Compliance to Adjuvant Therapy for Post-menopausal Hormone Sensitive Early Breast Cancer [NCT00555867]		4,923 participants (Actual)	Observational	2006-10-31	Terminated(stopped due to High drop-out rate leads to the conclusion: not enough data will be available to perform proper analyses of data collected after follow-up month 24 visit)
Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers: The EMPOwER Study [NCT03211572]	Phase 2	82 participants (Anticipated)	Interventional	2017-08-31	Not yet recruiting
Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Met [NCT00077025]	Phase 2	174 participants (Anticipated)	Interventional	2004-01-31	Completed
Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Sta [NCT00255463]	Phase 2	185 participants	Interventional	2004-01-31	Completed
Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy [NCT00077168]	Phase 2	2,000 participants (Anticipated)	Interventional	2004-04-30	Active, not recruiting
An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years [NCT00286117]	Phase 3	448 participants (Actual)	Interventional	1998-03-31	Completed
[NCT00286351]	Phase 4	20 participants	Interventional	2005-01-31	Completed
A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy. [NCT00300508]	Phase 3	856 participants	Interventional	1996-01-31	Completed
A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragil [NCT00082277]	Phase 4	237 participants (Actual)	Interventional	2004-04-30	Completed
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study [NCT05826964]	Phase 2	500 participants (Anticipated)	Interventional	2023-06-12	Recruiting
BOOG 2017-03: Endocrine Therapy Plus CDK 4/6 Inhibition in First- or Second-line for Hormone Receptor Positive Advanced Breast Cancer - the SONIA Study [NCT03425838]	Phase 3	1,050 participants (Actual)	Interventional	2017-11-09	Active, not recruiting
A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer [NCT00327769]	Phase 3	234 participants (Actual)	Interventional	2005-11-30	Completed
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole [NCT05635357]		16,989 participants (Actual)	Observational	2022-11-01	Active, not recruiting
Pilot for a Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Ant-Oestrogen Therapy Delayed Until After Radiotherapy [NCT00126360]	Phase 4	100 participants	Interventional	2005-08-31	Recruiting
Antiestrogen vs Aromatase Inhibitor After Chemotherapy for Adjuvant Setting: Efficacy of Endocrine Therapy After Chemotherapy in Postoperative Adjuvant Therapy for Breast Cancer [NCT00437359]	Phase 2	240 participants (Anticipated)	Interventional	2007-05-31	Terminated
Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole [NCT00421447]		58 participants (Actual)	Observational	2007-01-31	Completed
A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301) [NCT06072781]	Phase 3	270 participants (Anticipated)	Interventional	2023-12-31	Recruiting
Gonadal Steroid Regulation of the Natriuretic Peptide System [NCT01763541]	Early Phase 1	0 participants (Actual)	Interventional	2014-06-30	Withdrawn
An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced o [NCT03099174]	Phase 1	133 participants (Actual)	Interventional	2017-05-04	Active, not recruiting
Open-label, Multi-center, sINGlE Arm Clinical Study to Evaluate Efficacy/QoL in Women With HR+, HER2-, Regionally Recurrent or Metastatic Breast Cancer Receiving Palbociclib With an AI or Fulvestrant After Prior Endocrine Therapy [NCT02894398]	Phase 2	388 participants (Actual)	Interventional	2016-09-06	Completed
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation [NCT05307705]	Phase 1	400 participants (Anticipated)	Interventional	2022-05-11	Recruiting
A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension [NCT01545336]	Phase 2	18 participants (Actual)	Interventional	2012-10-31	Completed
A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer [NCT00181688]	Phase 2	35 participants	Interventional	2003-10-31	Completed
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer [NCT01674140]	Phase 3	1,939 participants (Actual)	Interventional	2013-09-12	Active, not recruiting
A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer [NCT01216176]	Phase 1/Phase 2	71 participants (Actual)	Interventional	2008-10-21	Completed
Regulation of Cortisol Metabolism and Fat Patterning [NCT00694733]		140 participants (Actual)	Interventional	2005-05-31	Active, not recruiting
A Partial Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole, an Aromatase Inhibitor, on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle (Protocol M-001) [NCT00467493]	Phase 2	64 participants (Actual)	Interventional	2007-03-31	Completed
Efficacy and Tolerance of Treatment With an Aromatase Inhibitor (Anastrozole) to Limit the Progression of Bone Maturation Related to Pathological Adrenarche in Children With Silver-Russell or Prader-Willi Syndrome [NCT01520467]		27 participants (Actual)	Interventional	2012-04-30	Active, not recruiting
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib [NCT04584853]	Phase 3	2,500 participants (Anticipated)	Interventional	2020-12-23	Recruiting
Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not [NCT01553903]	Phase 4	29 participants (Actual)	Interventional	2011-12-31	Completed
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 3	0 participants	Interventional	2002-11-30	Terminated
International Breast Cancer Intervention Study [NCT00078832]	Phase 3	3,864 participants (Actual)	Interventional	2003-09-30	Completed
A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy [NCT00049062]	Phase 2	0 participants	Interventional	2002-09-30	Completed
Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia [NCT02995772]	Phase 3	122 participants (Actual)	Interventional	2011-11-30	Completed
An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome [NCT00055302]	Phase 2	40 participants (Actual)	Interventional	2002-08-31	Completed
An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With Advanced Breast Cancer [NCT00066378]	Phase 2	71 participants (Actual)	Interventional	2003-05-31	Completed
International Breast Cancer Intervention Study II (IBIS-II) (DCIS) [NCT00072462]	Phase 3	2,980 participants (Actual)	Interventional	2003-09-30	Completed
A Pragmatic Randomised, Multicentre Trial Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) [NCT03948568]	Phase 4	262 participants (Actual)	Interventional	2019-09-17	Completed
Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency [NCT00133354]	Phase 2/Phase 3	53 participants (Actual)	Interventional	2001-11-30	Completed
Combined Fulvestrant and Anastrozole as Neo-adjuvant Endocrine Therapy in Postmenopausal Women With Hormone Receptor Positive Invasive Breast Cancer [NCT00921115]	Phase 2	42 participants (Actual)	Interventional	2009-05-31	Completed
Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function [NCT00719966]		109 participants (Anticipated)	Observational	2008-06-30	Active, not recruiting
Pulmonary Hypertension and Anastrozole Trial (PHANTOM) [NCT03229499]	Phase 2	84 participants (Actual)	Interventional	2017-12-07	Completed
Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer [NCT05150652]	Phase 2	70 participants (Anticipated)	Interventional	2022-02-18	Recruiting
A Randomised, Double-blind, Study Comparing ARIMIDEX™ With NOLVADEX™ as Neo-adjuvant and Adjuvant Treatment in Post-menopausal Women With Large Operable (T2 (≥3cm), T3, N0-2, M0) or Potentially-operable, Locally Advanced (T4b, N0-2, M0), ER+ and/or PR+ Br [NCT00232661]	Phase 3	452 participants (Actual)	Interventional	2000-08-31	Completed
An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer [NCT00235937]	Phase 2	45 participants (Anticipated)	Interventional	2001-12-31	Completed
An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset [NCT00241436]	Phase 2	35 participants	Interventional	2005-06-30	Completed
Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years. [NCT00291759]	Phase 3	3,858 participants (Actual)	Interventional	1996-01-31	Completed
INTERACT- Integrated Evaluation of Resistance and Actionability Using Circulating Tumor DNA in HR Positive Metastatic Breast Cancers [NCT04256941]	Phase 2	4 participants (Actual)	Interventional	2019-05-31	Completed
Mechanisms of Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men: Modulation of GHRH, GHRP and Somatostatin Action by Estrogenic Versus Androgenic Steroids [NCT00309855]	Phase 1	80 participants (Actual)	Interventional	2005-12-31	Completed
A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal [NCT00287534]	Phase 2	1,059 participants (Anticipated)	Interventional	1996-11-30	Completed
20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT) [NCT04569747]	Phase 2	375 participants (Anticipated)	Interventional	2021-01-11	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 2	257 participants (Actual)	Interventional	2017-10-05	Active, not recruiting
Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer, Phase II Study [NCT00303615]	Phase 2	5 participants (Actual)	Interventional	2005-06-30	Terminated(stopped due to Low accrural)
Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia [NCT05800197]		300 participants (Anticipated)	Observational	2014-04-15	Recruiting
A Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Anti-oestrogen Therapy Delayed Until After Radiotherapy. [NCT00887380]	Phase 3	2,023 participants (Actual)	Interventional	2009-09-16	Active, not recruiting
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer [NCT05467891]	Phase 2	200 participants (Anticipated)	Interventional	2022-09-13	Recruiting
neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety [NCT02441946]	Phase 2	224 participants (Actual)	Interventional	2015-08-31	Completed
Pre-operative Assessment of the Anti-Proliferative Effects and Genomic Alterations of 2 Weeks of Abiraterone Acetate Compared to 2 Weeks of an Aromatase Inhibitor in Post-menopausal Hormone Receptor Positive Operable Breast Cancer [NCT01814865]	Phase 2	0 participants (Actual)	Interventional	2013-05-31	Withdrawn(stopped due to Funding was not acquired)
A Phase 1b Study of Talimogene Laherparepvec (T-VEC) in Combination With Chemotherapy or Endocrine Therapy in Patients With Metastatic, Unresectable, or Locoregionally Recurrent HER2-negative Breast Cancer [NCT03554044]	Phase 1	20 participants (Actual)	Interventional	2020-02-05	Active, not recruiting
A Randomized Controlled Trial Of The Use Of Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature [NCT01248416]	Phase 3	76 participants (Actual)	Interventional	2010-11-30	Completed
Exploratory Study of HR-positive HER2-positive MBC Combined Treatment Plan [NCT05167643]		40 participants (Anticipated)	Interventional	2022-01-23	Recruiting
A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Posit [NCT04436744]	Phase 2	221 participants (Actual)	Interventional	2020-09-04	Completed
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positi [NCT01602380]	Phase 3	462 participants (Actual)	Interventional	2012-10-17	Active, not recruiting
A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B [NCT01720602]		15 participants (Actual)	Interventional	2012-11-30	Completed
Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer [NCT01394211]	Phase 2	2 participants (Actual)	Interventional	2011-07-13	Terminated(stopped due to Slow accrual)
A Phase II Randomized Trial of Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer Who Have Received First-line Platinum-based Chemotherapy With or Without Bevacizumab [NCT00932152]	Phase 2	3 participants (Actual)	Interventional	2010-09-30	Terminated(stopped due to Poor enrollment/suspended to accrual; will close per AstraZeneca request)
DETECT V / CHEVENDO A Multicenter, Randomized Phase III Study to Compare Chemo- Versus Endocrine Therapy in Combination With Dual HER2-targeted Therapy of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab) Plus Kisqali® (Ribociclib) in Patients With HER2 [NCT02344472]	Phase 3	270 participants (Anticipated)	Interventional	2015-09-30	Recruiting
A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting [NCT04553770]	Phase 2	88 participants (Anticipated)	Interventional	2020-10-09	Recruiting
A Phase II Pilot Study of Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support Without Conventional-Dose Induction Chemotherapy for Women With Metastatic Breast Cancer [NCT00004900]	Phase 2	0 participants	Interventional	1999-10-31	Completed
A Phase II Multi-Institution Study of Docetaxel and Doxorubicin as Induction Therapy Followed by Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support for Women With Metastatic Breast Cancer [NCT00004906]	Phase 2	0 participants	Interventional	1999-10-31	Completed
A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole [NCT00354640]	Phase 2	11 participants (Actual)	Interventional	2006-06-30	Completed
A Phase I/II Trial of BAY 43-9006 (Sorafenib) in Combination With Anastrozole in Patients With Metastatic Breast Cancer [NCT00217399]	Phase 1/Phase 2	35 participants (Actual)	Interventional	2005-06-30	Completed
Phase II Chemoprevention Trial - Anastrozole in the DCIS and Early Invasive Breast Cancer in Postmenopausal Women [NCT00256217]	Phase 2	42 participants (Actual)	Interventional	2004-09-21	Completed
Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism [NCT03490513]	Phase 4	120 participants (Anticipated)	Interventional	2018-04-15	Recruiting
Analysis of Therapy Sequence in Women With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer in Russia: A Multicentre Retrospective Observational Real-life Study. [NCT04852081]		1,000 participants (Anticipated)	Observational	2021-01-01	Recruiting
Basket Study of the Oral Progesterone Antagonist Onapristone ER (Apristor), Alone or In Combination With Anastrozole in Women With Progesterone Receptor Positive (PR+) Recurrent Granulosa Cell Tumor, Low Grade Serous Ovarian Cancer or Endometrioid Endomet [NCT03909152]	Phase 2	34 participants (Actual)	Interventional	2019-05-02	Active, not recruiting
CB-103 Plus NSAI In Luminal Advanced Breast Cancer: CAILA Study [NCT04714619]	Phase 2	2 participants (Actual)	Interventional	2021-05-06	Terminated(stopped due to Sponsor decision)
Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study. [NCT01612871]	Phase 4	39 participants (Actual)	Interventional	2012-06-27	Completed
Bevacizumab Plus Paclitaxel Optimization Study With Interventional Maintenance Endocrine Therapy in Advanced or Metastatic ER-positive HER2-negative Breast Cancer -BOOSTER Trial, a Multicenter Randomized Phase II Study- [NCT01989780]	Phase 2	160 participants (Actual)	Interventional	2014-01-31	Completed
Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study [NCT01953588]	Phase 3	1,473 participants (Actual)	Interventional	2013-12-13	Active, not recruiting
Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers. [NCT04757532]	Phase 1	9 participants (Actual)	Interventional	2020-12-03	Completed
A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy [NCT01153672]		8 participants (Actual)	Interventional	2010-11-30	Completed
Mechanisms of Control of the Intratesticular Hormonal Milieu in Man [NCT01215292]	Phase 1/Phase 2	46 participants (Actual)	Interventional	2011-01-31	Completed
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome [NCT00433173]		72 participants (Anticipated)	Interventional	2006-05-31	Suspended(stopped due to Primary investigator is taking a leave of absence)
Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer [NCT02291913]	Phase 2	48 participants (Actual)	Interventional	2014-12-18	Completed
Effect of Increasing Testosterone Levels on Insulin Sensitivity in Men With the Metabolic Syndrome [NCT00382057]	Phase 2	72 participants (Anticipated)	Interventional	2006-05-31	Withdrawn
A Phase 3 Randomized, Open-Label Study Of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01) [NCT06016738]	Phase 3	510 participants (Anticipated)	Interventional	2023-10-10	Recruiting
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fed Condition: A Open-label, Randomized,Single- Dose,Two-period, Two-group, Crossover Study [NCT04445922]	Phase 1	26 participants (Anticipated)	Interventional	2020-07-04	Not yet recruiting
Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot) [NCT02959853]	Phase 4	23 participants (Actual)	Interventional	2016-06-30	Completed
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II) [NCT00295646]	Phase 3	1,803 participants (Actual)	Interventional	1999-06-30	Completed
Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Bur [NCT04158362]	Phase 3	378 participants (Anticipated)	Interventional	2020-06-11	Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR-positive and HER2-negative Advanc [NCT05439499]	Phase 3	434 participants (Anticipated)	Interventional	2022-03-02	Recruiting
Randomized Phase 2 Trial of Anastrozole Combined With Novel Agent ZD6474 in the Neoadjuvant Treatment of Postmenopausal Patients With Hormone Receptor-Positive Breast Cancer [NCT00481845]	Phase 2	1 participants (Actual)	Interventional	2008-01-31	Terminated(stopped due to Low accrual)
An Open-label Phase 1b Study of ARQ 092 in Combination With Other Antineoplastic Agents in Subjects With Selected Solid Tumors [NCT02476955]	Phase 1	41 participants (Actual)	Interventional	2015-06-09	Terminated
An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR) [NCT03238703]	Phase 4	0 participants (Actual)	Interventional	2018-09-01	Withdrawn(stopped due to Administrative closure based on sponsor recommendation, prior to subject enrollment)
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer [NCT05257395]	Phase 3	372 participants (Anticipated)	Interventional	2022-02-28	Not yet recruiting
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition: A Open-label, Randomized,Single-dose,Two-period, Two-group, Crossover Study [NCT04438733]	Phase 1	26 participants (Anticipated)	Interventional	2020-06-18	Recruiting
A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer. [NCT00301457]	Phase 3	1,914 participants (Actual)	Interventional	2006-06-30	Completed
ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer [NCT05501704]	Phase 2	60 participants (Anticipated)	Interventional	2023-10-11	Recruiting
A Randomized, Double-blind, Double-dummy, Parallel- Group, Multi-center Phase IIb Study to Assess the Efficacy and Safety of Different Dose Combinations of an Aromatase Inhibitor and a Progestin in an Intravaginal Ring Versus Placebo and Leuprorelin / Leu [NCT02203331]	Phase 2	319 participants (Actual)	Interventional	2014-10-16	Completed
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance [NCT03219476]	Phase 2	37 participants (Actual)	Interventional	2017-02-05	Active, not recruiting
Feasibility of Pre-Surgical Intervention Studies for Evaluating Targeted Therapies for Breast Cancer [NCT01004744]		10 participants (Actual)	Interventional	2007-07-31	Completed
An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4/6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer [NCT04469764]	Phase 2	32 participants (Anticipated)	Interventional	2020-10-16	Recruiting
A Pilot Study Evaluating Megestrol Acetate Modulation in Advanced Breast Cancer With Positive Hormonal Receptor [NCT03024580]	Phase 2	20 participants (Anticipated)	Interventional	2017-03-06	Recruiting
A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile [NCT00213148]	Phase 2	271 participants (Actual)	Interventional	2005-03-10	Completed
Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer [NCT04023292]	Phase 2	185 participants (Anticipated)	Interventional	2019-07-31	Recruiting
Evaluation of the Relationship Between Drug Therapy, Food Consumption, Body Composition and Plasma Micronutients Levels With the Expression of Genes Related to Metabolism, Aging and Immunity in Women With Breast Cancer. [NCT04389424]		300 participants (Anticipated)	Observational	2017-09-01	Recruiting
Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor：a Prospective, Single-arm, Phase II Clinical Trial. [NCT05411380]	Phase 2	73 participants (Anticipated)	Interventional	2022-10-03	Recruiting
MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer [NCT02648477]	Phase 2	30 participants (Actual)	Interventional	2016-03-28	Active, not recruiting
A Prospective, Randomized, Open-label Phase III Clinical Study of the Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy Versus Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer [NCT05891093]	Phase 3	766 participants (Anticipated)	Interventional	2023-06-01	Recruiting
An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141 [NCT04886531]	Phase 2	48 participants (Anticipated)	Interventional	2022-07-21	Recruiting
A Phase II Multi-Institutional Study of Concurrent Radiotherapy, Palbociclib, and Hormone Therapy for Treatment of Bone Metastasis in Breast Cancer Patients [NCT03691493]	Phase 2	38 participants (Actual)	Interventional	2019-02-08	Completed
Phase II Pre-emptive OsciLLation of ER activitY Levels Through Alternation of Estradiol/Anti-estrogen Therapies Prior to Disease Progression in ER+/HER2- Metastatic or Advanced Breast Cancer [NCT02188745]	Phase 2	19 participants (Actual)	Interventional	2016-03-11	Active, not recruiting
A Double-blind, Randomized, Multicentre Trial to Compare the Anti-tumour Effects and Tolerability of a 500 mg Dose of Faslodex (Fulvestrant) Plus Arimidex (Anastrozole) With a 500 mg Dose of Faslodex(Fulvestrant) Alone and With Arimidex(Anastrozole) Alone [NCT00259090]	Phase 2	120 participants (Actual)	Interventional	2004-04-30	Completed
A Phase II Trial of Neoadjuvant MK-2206 in Combination With Either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women With Clinical Stage 2 or 3 PIK3CA Mutant Estrogen Receptor Positive and HER2 Negative Invasive Breast C [NCT01776008]	Phase 2	16 participants (Actual)	Interventional	2013-01-31	Terminated(stopped due to Study did not pass Stage 1 interim analysis.)
A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer [NCT02779751]	Phase 1	100 participants (Anticipated)	Interventional	2016-11-14	Active, not recruiting
A Single Arm Phase IIa Study (With Combination SRI) to Assess the Safety & Efficacy of AZD4547 in Combination With Either Anastrozole or Letrozole in ER+ Breast Cancer Patients Who Have Progressed on Treatment With Anastrozole or Letrozole [NCT01791985]	Phase 1/Phase 2	52 participants (Actual)	Interventional	2012-07-31	Completed
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer [NCT00248170]	Phase 3	4,172 participants (Actual)	Interventional	2005-12-31	Completed
1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma [NCT02000596]	Phase 2	2 participants (Actual)	Interventional	2014-01-31	Terminated(stopped due to funding withdrawn by sponsor)
Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone) [NCT06086340]		782 participants (Anticipated)	Observational	2023-09-29	Active, not recruiting
Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients [NCT01814397]		50 participants (Actual)	Observational	2009-07-31	Completed
A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer [NCT00081510]	Phase 2	110 participants (Actual)	Interventional	2003-12-31	Completed
A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER [NCT01597193]	Phase 1	101 participants (Actual)	Interventional	2012-04-30	Completed
A Phase II Trial of Open-Label Bevacizumab Administered With Anastrozole or Fulvestrant as First-Line Therapy in Postmenopausal Hormone Receptor- Positive Metastatic Breast Cancer (With Trastuzumab in HER2-Positive Patients) [NCT00405938]	Phase 2	79 participants (Actual)	Interventional	2006-11-30	Completed
The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male [NCT00440180]	Phase 3	20 participants (Actual)	Interventional	2007-03-31	Terminated(stopped due to Not able meet target enrollment.)
Flaxseed vs. Aromatase Inhibitors: Breast Tumor Characteristics and Prognosis [NCT00612560]		28 participants (Actual)	Interventional	2007-11-30	Completed
Randomization to Letrozole vs. Anastrozole in Short Pubertal Males [NCT02137538]	Phase 4	79 participants (Actual)	Interventional	2009-11-18	Completed
A Multisite International Collaborative Phase 2 Study of Neoadjuvant Goserelin and a Non-steroidal Aromatase Inhibitor for Premenopausal Women With Estrogen Receptor Positive HER2 Negative Clinical Stage 2 and 3 Breast Cancer [NCT01368263]	Phase 2	8 participants (Actual)	Interventional	2011-09-30	Terminated(stopped due to Due to funding source and lack of accrual)
An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect [NCT02093351]	Phase 1	79 participants (Actual)	Interventional	2014-09-01	Completed
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen [NCT01896050]		115 participants (Actual)	Observational	2009-09-30	Completed
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women [NCT03314298]	Phase 1	11 participants (Actual)	Interventional	2017-08-14	Completed
Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study [NCT05586802]	Phase 3	120 participants (Anticipated)	Interventional	2023-03-21	Recruiting
Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score [NCT02476786]	Phase 2	50 participants (Anticipated)	Interventional	2017-01-17	Recruiting
A Phase II Trial With Safety Run-in of Neoadjuvant Therapy With an Aromatase Inhibitor in Combination With Durvalumab (MEDI4736) in Postmenopausal Patients With Hormone-Receptor-Positive Breast Cancer [NCT03874325]	Phase 2	17 participants (Actual)	Interventional	2019-04-26	Terminated(stopped due to lost funding)
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse [NCT05512364]	Phase 3	220 participants (Anticipated)	Interventional	2023-12-15	Not yet recruiting
A Randomised Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer [NCT04985266]	Phase 2	1,100 participants (Anticipated)	Interventional	2022-03-30	Recruiting
A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer [NCT00066573]	Phase 3	7,576 participants (Actual)	Interventional	2003-06-06	Completed
Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients [NCT02137837]	Phase 3	37 participants (Actual)	Interventional	2014-05-31	Terminated(stopped due to lack of accrual)
Cardiovascular Consequences of Hypogonadism in Men [NCT02758431]		379 participants (Anticipated)	Interventional	2016-07-01	Active, not recruiting
Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer [NCT02269670]	Phase 2	3 participants (Actual)	Interventional	2014-11-25	Terminated(stopped due to Slow to accrual)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00005908 (4) [back to overview]	Number of Participants With Adverse Events
NCT00005908 (4) [back to overview]	Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models
NCT00005908 (4) [back to overview]	Complementary Deoxyribonucleic Acid (cDNA) Expression
NCT00005908 (4) [back to overview]	Overall Clinical Response Rate
NCT00022672 (14) [back to overview]	Percentage of Participants With Best Tumor Response at 24 Months
NCT00022672 (14) [back to overview]	Number of Participants With Adverse Events
NCT00022672 (14) [back to overview]	Overall Survival at 24 Months
NCT00022672 (14) [back to overview]	Percentage of Participants With Overall Tumor Response at 24 Months
NCT00022672 (14) [back to overview]	Percentage of Participants With Overall Tumor Response at End of Study
NCT00022672 (14) [back to overview]	Percentage of Participants With Two-Year Survival
NCT00022672 (14) [back to overview]	Time to Response at 24 Months
NCT00022672 (14) [back to overview]	Time to Response at End of Study
NCT00022672 (14) [back to overview]	Duration of Response at End of Study
NCT00022672 (14) [back to overview]	Progression Free Survival (PFS)
NCT00022672 (14) [back to overview]	Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline
NCT00022672 (14) [back to overview]	Percentage of Participants With Clinical Benefit
NCT00022672 (14) [back to overview]	Percentage of Participants With Best Tumor Response at End of Study
NCT00022672 (14) [back to overview]	Duration of Response at 24 Months
NCT00053898 (10) [back to overview]	Percentage of Patients Alive and Disease-free
NCT00053898 (10) [back to overview]	Percentage of Patients Free From Breast Cancer
NCT00053898 (10) [back to overview]	Percentage of Patients Free From Contralateral Breast Cancer
NCT00053898 (10) [back to overview]	Percentage of Patients Free From Invasive Breast Cancer
NCT00053898 (10) [back to overview]	Percentage of Patients Free From Ipsilateral Recurrence
NCT00053898 (10) [back to overview]	Percentage of Patients Free From Non-breast Secondary Cancer
NCT00053898 (10) [back to overview]	Percentage of Patients Alive (Overall Survival)
NCT00053898 (10) [back to overview]	Quality of Life-Short Form 12 (SF-12) Physical Health Component Score
NCT00053898 (10) [back to overview]	Quality-adjusted Survival Time
NCT00053898 (10) [back to overview]	Percentage of Patients Free From Osteoporotic Fractures
NCT00057941 (1) [back to overview]	Clinical Benefit Rate
NCT00066573 (4) [back to overview]	Overall Survival: Percentage of Participants Alive at 5 Years
NCT00066573 (4) [back to overview]	Clinical Fracture Rate: Number of Participants With Bone Fractures.
NCT00066573 (4) [back to overview]	Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence
NCT00066573 (4) [back to overview]	Event-free Survival
NCT00075764 (4) [back to overview]	Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).
NCT00075764 (4) [back to overview]	Overall Survival
NCT00075764 (4) [back to overview]	Time to Tumor Progression
NCT00075764 (4) [back to overview]	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT00094328 (9) [back to overview]	Change in Growth Rate (cm/Year)
NCT00094328 (9) [back to overview]	Change in Growth Rate (SD Units)
NCT00094328 (9) [back to overview]	Change in Growth Rate (SD Units)
NCT00094328 (9) [back to overview]	Change in Predicted Adult Height (PAH)
NCT00094328 (9) [back to overview]	Change in Average Testicular Volume
NCT00094328 (9) [back to overview]	Change in Bone Age Maturation Rate (cm/Year)
NCT00094328 (9) [back to overview]	Change in Bone Age to Chronological Age Ratio
NCT00094328 (9) [back to overview]	Change in Growth Rate (cm/Year)
NCT00094328 (9) [back to overview]	Number of Patients With Height Between 5th and 95th Percentile
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
NCT00111241 (2) [back to overview]	Knee Cartilage Volume
NCT00111241 (2) [back to overview]	Knee Subchondral Bone Expansion
NCT00136695 (1) [back to overview]	Change in Lean Body Mass
NCT00143390 (6) [back to overview]	Overall Survival (OS)
NCT00143390 (6) [back to overview]	Time to Progression (TTP) - Expert Evaluation Committee Assessment
NCT00143390 (6) [back to overview]	Time to Progression (TTP) - Investigators Assessment
NCT00143390 (6) [back to overview]	Time to Treatment Failure (TTF)
NCT00143390 (6) [back to overview]	Number of Participants With Clinical Benefit - Investigator Assessment
NCT00143390 (6) [back to overview]	Number of Participants With Objective Response - Investigators Assessment
NCT00179517 (9) [back to overview]	Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
NCT00179517 (9) [back to overview]	The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.
NCT00179517 (9) [back to overview]	Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
NCT00179517 (9) [back to overview]	Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).
NCT00179517 (9) [back to overview]	Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
NCT00179517 (9) [back to overview]	Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
NCT00179517 (9) [back to overview]	Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
NCT00179517 (9) [back to overview]	Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
NCT00179517 (9) [back to overview]	The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
NCT00186121 (7) [back to overview]	Clinical Benefit Rate
NCT00186121 (7) [back to overview]	Objective Response Rate (ORR)
NCT00186121 (7) [back to overview]	Overall Survival (OS)
NCT00186121 (7) [back to overview]	Serious Adverse Events
NCT00186121 (7) [back to overview]	Time-to-Progression (TTP)
NCT00186121 (7) [back to overview]	Estradiol Suppression
NCT00186121 (7) [back to overview]	Response Rates
NCT00213148 (2) [back to overview]	Ovulation Rate in Cycle 1
NCT00213148 (2) [back to overview]	Number of Subjects With Clinical Pregnancy in Cycle 1
NCT00217399 (3) [back to overview]	Number of Participants With Adverse Events
NCT00217399 (3) [back to overview]	Tumor Marker Analysis
NCT00217399 (3) [back to overview]	Complete Response + Partial Response + Stable Disease > 24 Weeks
NCT00248170 (8) [back to overview]	Time to Development of Contra Lateral Breast Cancer
NCT00248170 (8) [back to overview]	Distant Disease-free Survival
NCT00248170 (8) [back to overview]	Overall Survival
NCT00248170 (8) [back to overview]	Percentage of Participants Who Experienced Clinical Fracture Events
NCT00248170 (8) [back to overview]	Time to Development of Distant Metastases
NCT00248170 (8) [back to overview]	Change From Baseline in Serum Lipid Profiles
NCT00248170 (8) [back to overview]	Percentage of Participants Who Experienced Cardiovascular Events
NCT00248170 (8) [back to overview]	Disease Free Survival
NCT00256698 (7) [back to overview]	Percentage of Evaluable Participants With Objective Response Rate (ORR)
NCT00256698 (7) [back to overview]	Percentage of Clinical Benefit Rate (CBR) Responders
NCT00256698 (7) [back to overview]	Overall Survival (OS)
NCT00256698 (7) [back to overview]	Duration of Response (DoR)
NCT00256698 (7) [back to overview]	Duration of Clinical Benefit (DoCB)
NCT00256698 (7) [back to overview]	Time to Treatment Failure (TTF)
NCT00256698 (7) [back to overview]	Time to Progression (TTP)
NCT00259090 (3) [back to overview]	Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.
NCT00259090 (3) [back to overview]	Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.
NCT00259090 (3) [back to overview]	Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.
NCT00265759 (7) [back to overview]	Toxicity (Cohort A)
NCT00265759 (7) [back to overview]	Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)
NCT00265759 (7) [back to overview]	Clinical Response (Complete or Partial Response) Rate (Cohort A)
NCT00265759 (7) [back to overview]	Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)
NCT00265759 (7) [back to overview]	Rate of Lymph Node Involvement (LNI) (Cohort A)
NCT00265759 (7) [back to overview]	The Pathologic Complete Response (pCR) Rate (Cohort A)
NCT00265759 (7) [back to overview]	Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)
NCT00274469 (6) [back to overview]	Overall Survival
NCT00274469 (6) [back to overview]	Time to Progression
NCT00274469 (6) [back to overview]	Time to Progression (Investigator Assessed)
NCT00274469 (6) [back to overview]	Time to Treatment Failure
NCT00274469 (6) [back to overview]	Clinical Benefit Rate
NCT00274469 (6) [back to overview]	Objective Response Rate
NCT00295620 (5) [back to overview]	Time to Contralateral Breast Cancer
NCT00295620 (5) [back to overview]	Overall Survival After Prolonged Endocrine Treatment
NCT00295620 (5) [back to overview]	Disease-free Survival After Prolonged Endocrine Treatment
NCT00295620 (5) [back to overview]	Time to Secondary Carcinoma
NCT00295620 (5) [back to overview]	Time to First Clinical Fracture
NCT00310180 (5) [back to overview]	5-year Distant Recurrence-free Interval
NCT00310180 (5) [back to overview]	5-year Disease-free Survival
NCT00310180 (5) [back to overview]	5-year Disease-free Survival by Age and Recurrence Score Groups
NCT00310180 (5) [back to overview]	5-year Recurrence-free Interval
NCT00310180 (5) [back to overview]	5-year Overall Survival
NCT00323479 (6) [back to overview]	Percentage of Participant With Therapeutic Maintenance Under Anastrozole
NCT00323479 (6) [back to overview]	Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
NCT00323479 (6) [back to overview]	Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
NCT00323479 (6) [back to overview]	Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
NCT00323479 (6) [back to overview]	Number of Participants With New Events of Arthralgia
NCT00323479 (6) [back to overview]	Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
NCT00354640 (2) [back to overview]	Change in Serum Estradiol Levels
NCT00354640 (2) [back to overview]	Change in Blood Concentrations
NCT00357110 (1) [back to overview]	Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
NCT00405938 (2) [back to overview]	Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
NCT00405938 (2) [back to overview]	Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
NCT00440180 (1) [back to overview]	Pregnancy Rate
NCT00481845 (2) [back to overview]	Tumor Objective Response by MRI
NCT00481845 (2) [back to overview]	Pathologic Complete Response
NCT00537771 (3) [back to overview]	Time to Treatment Failure
NCT00537771 (3) [back to overview]	Incidence of Abnormal Liver Function
NCT00537771 (3) [back to overview]	Incidence of Fatty Liver Disease
NCT00543127 (4) [back to overview]	Time to Recurrence (TR) Event
NCT00543127 (4) [back to overview]	Overall Survival (OS) Event
NCT00543127 (4) [back to overview]	Breast Cancer Specific Survival (BCsS) Events
NCT00543127 (4) [back to overview]	Disease Free Survival (DFS) Events
NCT00555477 (1) [back to overview]	The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy
NCT00570323 (1) [back to overview]	Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples
NCT00573755 (2) [back to overview]	Adverse Event
NCT00573755 (2) [back to overview]	Progression-free Survival
NCT00605267 (17) [back to overview]	Human Epidermal Growth Factor Receptor 2 (HER2) Status
NCT00605267 (17) [back to overview]	Serum Oestrone (E1) Concentrations
NCT00605267 (17) [back to overview]	Serum Oestradiol (E2) Concentrations
NCT00605267 (17) [back to overview]	Histopathological Response Rate (HRR)
NCT00605267 (17) [back to overview]	Functional Assessment of Cancer Therapy-Breast (FACT-B)
NCT00605267 (17) [back to overview]	Endocrine Subscale (ES)
NCT00605267 (17) [back to overview]	Anastrozole Plasma Concentrations (Cmin)
NCT00605267 (17) [back to overview]	Best Overall Response Rate (BORR) (MRI/CT)
NCT00605267 (17) [back to overview]	Bone Turnover Marker (NTX)
NCT00605267 (17) [back to overview]	Bone Turnover Marker (BAP) EIA Method
NCT00605267 (17) [back to overview]	Bone Turnover Marker (BAP) CLEIA Method
NCT00605267 (17) [back to overview]	Bone Mineral Density (BMD) Lumbar Spine
NCT00605267 (17) [back to overview]	Bone Mineral Density (BMD) Cervical Thighbone
NCT00605267 (17) [back to overview]	Best Overall Response Rate (BORR) (US)
NCT00605267 (17) [back to overview]	Best Overall Response Rate (BORR) (Calliper)
NCT00605267 (17) [back to overview]	Progesterone Receptor (PgR) Status
NCT00605267 (17) [back to overview]	Oestrogen Receptor (ER) Status
NCT00612560 (5) [back to overview]	Expression of Estrogen Receptor (ER-beta)
NCT00612560 (5) [back to overview]	Human Epidermal Growth Factor Receptor 2 (Her2) Expression
NCT00612560 (5) [back to overview]	Human Epidermal Growth Factor Receptor 2 (Her2) Expression
NCT00612560 (5) [back to overview]	Growth Hormone Serum Levels IGF-1
NCT00612560 (5) [back to overview]	Progesterone Receptor (PR) Expression
NCT00661531 (2) [back to overview]	Response Rate
NCT00661531 (2) [back to overview]	Progression Free Survival
NCT00728949 (6) [back to overview]	Number of Participants Experiencing Adverse Events (AEs) in National Cancer Institute Common Toxicity Criteria for AE's (NCI-CTCAE) Version 3.0 Criteria for Adverse Events (NCI-CTCAE)
NCT00728949 (6) [back to overview]	Percentage of Participants With Complete Response (CR) and Partial Response (PR) or Stable Disease (SD) Disease Control Rate [DCR])
NCT00728949 (6) [back to overview]	12-Month Survival Rate
NCT00728949 (6) [back to overview]	Progression-Free Survival (PFS)
NCT00728949 (6) [back to overview]	Overall Survival (OS)
NCT00728949 (6) [back to overview]	Percentage of Participants With Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
NCT00729859 (10) [back to overview]	Endothelial Progenitor Cells
NCT00729859 (10) [back to overview]	Quantitative Insulin Sensitivity Check Index (QUICKI)
NCT00729859 (10) [back to overview]	Estradiol Concentration
NCT00729859 (10) [back to overview]	Fasting Lipid Levels
NCT00729859 (10) [back to overview]	Fasting Serum Insulin
NCT00729859 (10) [back to overview]	Follicle Stimulating Hormone (FSH)
NCT00729859 (10) [back to overview]	Homeostasis Model of Insulin Resistance (HOMA-IR)
NCT00729859 (10) [back to overview]	Luteinizing Hormone Concentration (LH)
NCT00729859 (10) [back to overview]	Sex Hormone Binding Globulin (SHBG)
NCT00729859 (10) [back to overview]	Testosterone Concentration
NCT00871858 (5) [back to overview]	Objective Response Rate (ORR) Determined by Mammography
NCT00871858 (5) [back to overview]	Objective Response Rate (ORR) Determined by Ultrasound
NCT00871858 (5) [back to overview]	Percentage of Participants With 5-year Relapse-Free Survival
NCT00871858 (5) [back to overview]	Rate of Breast-conserving Surgery
NCT00871858 (5) [back to overview]	Objective Response Rate (ORR) Determined by Clinical Palpation
NCT00921115 (1) [back to overview]	Pathologic Complete Response (PCR) Rate
NCT01004744 (1) [back to overview]	Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery
NCT01151215 (2) [back to overview]	Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
NCT01151215 (2) [back to overview]	Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
NCT01153672 (5) [back to overview]	Duration of Response
NCT01153672 (5) [back to overview]	Overall Survival
NCT01153672 (5) [back to overview]	Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
NCT01153672 (5) [back to overview]	Progression-free Survival
NCT01153672 (5) [back to overview]	Rate of Clinical Benefit According to RECIST
NCT01182181 (2) [back to overview]	Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
NCT01182181 (2) [back to overview]	AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01183390 (2) [back to overview]	Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)
NCT01183390 (2) [back to overview]	AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01215292 (3) [back to overview]	Intratesticular Dihydrotestosterone (DHT) Level
NCT01215292 (3) [back to overview]	Intratesticular Testosterone (IT-T) Level
NCT01215292 (3) [back to overview]	Intratesticular Androstenedione (ADD) Level
NCT01216176 (10) [back to overview]	Phase II - Cohort B: Number of Participants With Pathologic Complete Response (pCR)
NCT01216176 (10) [back to overview]	Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI
NCT01216176 (10) [back to overview]	Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD)
NCT01216176 (10) [back to overview]	Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response
NCT01216176 (10) [back to overview]	Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole
NCT01216176 (10) [back to overview]	Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole
NCT01216176 (10) [back to overview]	Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole)
NCT01216176 (10) [back to overview]	Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole
NCT01216176 (10) [back to overview]	Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole
NCT01216176 (10) [back to overview]	Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo
NCT01234532 (5) [back to overview]	Number of Participants With Adverse Events
NCT01234532 (5) [back to overview]	Change in Proliferative Index (Ki67) (Phase II)
NCT01234532 (5) [back to overview]	Change in HER2
NCT01234532 (5) [back to overview]	Change in Estrogen-receptor (ER) Expression (Phase II)
NCT01234532 (5) [back to overview]	Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot)
NCT01248416 (9) [back to overview]	Change in Body Mass Index
NCT01248416 (9) [back to overview]	Change in Bone Density z Score Adjusted for Height
NCT01248416 (9) [back to overview]	Change in Estradiol
NCT01248416 (9) [back to overview]	Change in Estrone
NCT01248416 (9) [back to overview]	Change in Height
NCT01248416 (9) [back to overview]	Change in Testosterone
NCT01248416 (9) [back to overview]	Change in Predicted Height
NCT01248416 (9) [back to overview]	Change in Lean Body Mass
NCT01248416 (9) [back to overview]	Change in IGF-I Concentrations
NCT01272037 (3) [back to overview]	Distant Relapse-Free Survival (DRFS)
NCT01272037 (3) [back to overview]	Invasive Disease-Free Survival (IDFS)
NCT01272037 (3) [back to overview]	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT01368263 (2) [back to overview]	Preoperative Endocrine Prognostic Index Score (PEPI Score)
NCT01368263 (2) [back to overview]	PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less
NCT01545336 (3) [back to overview]	Plasma Estradiol (E2) Level
NCT01545336 (3) [back to overview]	Six Minute Walk Distance
NCT01545336 (3) [back to overview]	Tricuspid Annular Plane Systolic Excursion (TAPSE)
NCT01597193 (21) [back to overview]	Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing
NCT01597193 (21) [back to overview]	Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing
NCT01597193 (21) [back to overview]	Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing
NCT01597193 (21) [back to overview]	Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)
NCT01597193 (21) [back to overview]	Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing
NCT01597193 (21) [back to overview]	Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide
NCT01597193 (21) [back to overview]	Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events
NCT01597193 (21) [back to overview]	Percentage of Participants Who Require Dose Reductions Due to Adverse Events
NCT01597193 (21) [back to overview]	Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)
NCT01602380 (9) [back to overview]	Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL)
NCT01602380 (9) [back to overview]	Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
NCT01602380 (9) [back to overview]	Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
NCT01602380 (9) [back to overview]	Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
NCT01602380 (9) [back to overview]	Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
NCT01602380 (9) [back to overview]	Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment
NCT01602380 (9) [back to overview]	Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
NCT01602380 (9) [back to overview]	Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
NCT01602380 (9) [back to overview]	Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
NCT01674140 (4) [back to overview]	Overall Survival (OS)
NCT01674140 (4) [back to overview]	Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
NCT01674140 (4) [back to overview]	Distant Recurrence-Free Survival (DRFS)
NCT01674140 (4) [back to overview]	Invasive Disease-Free Survival (IDFS)
NCT01720602 (5) [back to overview]	Overall Survival
NCT01720602 (5) [back to overview]	Duration of Response
NCT01720602 (5) [back to overview]	Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST
NCT01720602 (5) [back to overview]	Response Rate According to RECIST
NCT01720602 (5) [back to overview]	Progression-free Survival (PFS)
NCT01723774 (12) [back to overview]	Number of Participants With Complete Cell Cycle Arrest
NCT01723774 (12) [back to overview]	Number of Participants With Pathologic Complete Response (pCR)
NCT01723774 (12) [back to overview]	Change in Ki67 Level of Tumor Specimens
NCT01723774 (12) [back to overview]	Change in Ki67 Level of Tumor Specimens
NCT01723774 (12) [back to overview]	Radiologic Response Rate
NCT01723774 (12) [back to overview]	Clinical Response Rate
NCT01723774 (12) [back to overview]	Safety of PD 0332991 in Combination in Anastrozole as Measured by Frequency and Grade of Related Adverse Events
NCT01723774 (12) [back to overview]	Safety Profile of Study Therapy During Adjuvant Therapy as Measured by Frequency and Grade of Adverse Event
NCT01723774 (12) [back to overview]	Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 ( PIK3CA Mutant Type Cohort Only)
NCT01723774 (12) [back to overview]	Number of Participants With a PEPI-0 Score
NCT01723774 (12) [back to overview]	Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (Endocrine Resistant Cohort Only)
NCT01723774 (12) [back to overview]	Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (PIK3CA Wild Type Cohort Only)
NCT01776008 (2) [back to overview]	Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT01776008 (2) [back to overview]	Pathological Complete Response Rate
NCT01791985 (6) [back to overview]	Proportion of Tumour Size Change at 12 Weeks (or Progression if Prior to Week 12)
NCT01791985 (6) [back to overview]	Progression Free Survival
NCT01791985 (6) [back to overview]	Number of Participants With Serious Adverse Events (SAEs)
NCT01791985 (6) [back to overview]	Proportion of Tumour Size Change at 6, 20 and 28 Weeks
NCT01791985 (6) [back to overview]	Objective Response at 6, 12, 20 and 28 Weeks
NCT01791985 (6) [back to overview]	Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks
NCT01814397 (4) [back to overview]	Mean Pain50 Assessed at Baseline, 3 Months and 6 Months
NCT01814397 (4) [back to overview]	Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months
NCT01814397 (4) [back to overview]	Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment
NCT01814397 (4) [back to overview]	Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy
NCT01896050 (3) [back to overview]	Effect of Medication on Change in Grip Strength
NCT01896050 (3) [back to overview]	Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months
NCT01896050 (3) [back to overview]	Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy
NCT02000596 (4) [back to overview]	Overall Response Rate (ORR) in Patients
NCT02000596 (4) [back to overview]	Progression-free Survival (PFS)
NCT02000596 (4) [back to overview]	Overall Survival (OS)
NCT02000596 (4) [back to overview]	Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
NCT02040857 (6) [back to overview]	All GradeTreatment-Related Alopecia Toxicity Rate
NCT02040857 (6) [back to overview]	Grade 3-4 Treatment-Related Neutropenia Toxicity Rate
NCT02040857 (6) [back to overview]	Rate of Treatment Related Discontinuation
NCT02040857 (6) [back to overview]	2-Year Treatment Discontinuation Rate
NCT02040857 (6) [back to overview]	2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup
NCT02040857 (6) [back to overview]	All Grade Treatment-Related Fatigue Toxicity Rate
NCT02093351 (12) [back to overview]	Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ
NCT02093351 (12) [back to overview]	Effect of Olaparib on Exposure to Tamoxifen - Cmax ss
NCT02093351 (12) [back to overview]	Effect of Olaparib on Exposure to Letrozole - AUC0-τ
NCT02093351 (12) [back to overview]	Effect of Anastrozole on Exposure to Olaparib - Cmax ss
NCT02093351 (12) [back to overview]	Effect of Anastrozole on Exposure to Olaparib - AUC0-τ
NCT02093351 (12) [back to overview]	Effect of Tamoxifen on Exposure to Olaparib - Cmax ss
NCT02093351 (12) [back to overview]	Effect of Olaparib on Exposure to Letrozole - Cmax ss
NCT02093351 (12) [back to overview]	Effect of Olaparib on Exposure to Anastrozole - Cmax ss
NCT02093351 (12) [back to overview]	Effect of Letrozole on Exposure to Olaparib - Cmax ss
NCT02093351 (12) [back to overview]	Effect of Olaparib on Exposure to Anastrozole - AUC0-τ
NCT02093351 (12) [back to overview]	Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ
NCT02093351 (12) [back to overview]	Effect of Letrozole on Exposure to Olaparib - AUC0-τ
NCT02137538 (11) [back to overview]	Androstenedione
NCT02137538 (11) [back to overview]	Dihydrotestosterone
NCT02137538 (11) [back to overview]	Estrone
NCT02137538 (11) [back to overview]	Follicle Stimulating Hormone
NCT02137538 (11) [back to overview]	Inhibin B
NCT02137538 (11) [back to overview]	Luteinizing Hormone
NCT02137538 (11) [back to overview]	Number of Adverse Events Related to Acne or Bone Fracture
NCT02137538 (11) [back to overview]	Serum Testosterone
NCT02137538 (11) [back to overview]	Estradiol
NCT02137538 (11) [back to overview]	Insulin-like Growth Factor Type 1
NCT02137538 (11) [back to overview]	Predicted Adult Height at Year 3
NCT02137837 (8) [back to overview]	Response Rate
NCT02137837 (8) [back to overview]	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT02137837 (8) [back to overview]	Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus )
NCT02137837 (8) [back to overview]	Progression-free Survival (Fulvestrant Versus Fulvestrant + Everolimus + Anastrozole)
NCT02137837 (8) [back to overview]	Progression Free Survival (Fulvestrant + Everolimus vs Fulvestrant + Everolimus + Anastrozole)
NCT02137837 (8) [back to overview]	Overall Survival
NCT02137837 (8) [back to overview]	Molecular Determinants of Response in Circulating Tumor Cells: CTC-ETI
NCT02137837 (8) [back to overview]	Clinical Benefit Rate
NCT02203331 (7) [back to overview]	Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
NCT02203331 (7) [back to overview]	Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
NCT02203331 (7) [back to overview]	Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
NCT02203331 (7) [back to overview]	Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD
NCT02203331 (7) [back to overview]	Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
NCT02203331 (7) [back to overview]	Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD
NCT02203331 (7) [back to overview]	Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
NCT02246621 (12) [back to overview]	Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
NCT02246621 (12) [back to overview]	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
NCT02246621 (12) [back to overview]	Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
NCT02246621 (12) [back to overview]	Duration of Response (DoR)
NCT02246621 (12) [back to overview]	Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
NCT02246621 (12) [back to overview]	Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
NCT02246621 (12) [back to overview]	Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
NCT02246621 (12) [back to overview]	PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
NCT02246621 (12) [back to overview]	Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
NCT02246621 (12) [back to overview]	Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
NCT02246621 (12) [back to overview]	Progression Free Survival (PFS)
NCT02246621 (12) [back to overview]	Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
NCT02278120 (5) [back to overview]	Clinical Benefit Rate (CBR)
NCT02278120 (5) [back to overview]	Duration of Response (DOR) Per Investigator's Assessment - Patients With Confirmed Complete Response (CR) or Partial Response (PR)
NCT02278120 (5) [back to overview]	Time to Response (TTR) Per Local Investigator's Assessment
NCT02278120 (5) [back to overview]	Progression Free Survival (PFS) Per Investigator's Assessment
NCT02278120 (5) [back to overview]	Overall Response Rate (ORR) Per Local Assessment
NCT02291913 (6) [back to overview]	Number of Patients With Adverse Events (AEs) as a Measure of Safety and Tolerability
NCT02291913 (6) [back to overview]	Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR).
NCT02291913 (6) [back to overview]	Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR)
NCT02291913 (6) [back to overview]	Median Overall Survival (OS)
NCT02291913 (6) [back to overview]	Median Progression Free Survival (PFS)
NCT02291913 (6) [back to overview]	Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR)
NCT02441946 (7) [back to overview]	PK: Apparent Volume of Distribution of Abemaciclib
NCT02441946 (7) [back to overview]	Percentage of Participants With Pathologic Complete Response (pCR)
NCT02441946 (7) [back to overview]	Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response
NCT02441946 (7) [back to overview]	Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
NCT02441946 (7) [back to overview]	Percent Change From Baseline to 2 Weeks in Ki67 Expression
NCT02441946 (7) [back to overview]	Pharmacokinetics (PK): Apparent Clearance of Abemaciclib
NCT02441946 (7) [back to overview]	Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response
NCT02648477 (4) [back to overview]	Number of Participants With Overall Response
NCT02648477 (4) [back to overview]	Progression-free Survival (PFS)
NCT02648477 (4) [back to overview]	Overall Survival (OS)
NCT02648477 (4) [back to overview]	Clinical Benefit Rate
NCT02763566 (7) [back to overview]	Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)
NCT02763566 (7) [back to overview]	Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
NCT02763566 (7) [back to overview]	Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]
NCT02763566 (7) [back to overview]	Progression Free Survival (PFS) (Abemaciclib + Fulvestrant and Placebo + Fulvestrant Arms)
NCT02763566 (7) [back to overview]	Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20)
NCT02763566 (7) [back to overview]	Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
NCT02763566 (7) [back to overview]	Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
NCT02959853 (6) [back to overview]	Change in Visceral Adipose Tissue (in Grams)
NCT02959853 (6) [back to overview]	Change in Fat Mass (in Kilograms)
NCT02959853 (6) [back to overview]	Change in Symptoms Score of Hypogonadism
NCT02959853 (6) [back to overview]	Percent Change in Bone Mineral Density
NCT02959853 (6) [back to overview]	Percent Change in Muscle Strength as Assessed by Knee Extension and Knee Flexion
NCT02959853 (6) [back to overview]	Percent Change in Bone Quality
NCT03219476 (3) [back to overview]	Number of Subjects Who Achieve a Partial Radiographic Response.
NCT03219476 (3) [back to overview]	Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.
NCT03219476 (3) [back to overview]	Number of Subjects Who Achieve Complete Radiographic Response.
NCT03778931 (4) [back to overview]	Progression-free Survival in ESR1-mut Subjects
NCT03778931 (4) [back to overview]	Overall Survival in ESR1-mut Subjects
NCT03778931 (4) [back to overview]	Progression-free Survival in All Subjects
NCT03778931 (4) [back to overview]	Overall Survival in All Subjects
NCT03874325 (3) [back to overview]	Clinical Complete Response (CR)
NCT03874325 (3) [back to overview]	Clinical Partial Response (PR)
NCT03874325 (3) [back to overview]	Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Screen
NCT03933618 (95) [back to overview]	LH - Week 8
NCT03933618 (95) [back to overview]	Normalized Testosterone - Screen
NCT03933618 (95) [back to overview]	Normalized Testosterone - Screen
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 16
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 24
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 24
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 24
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 8
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 8
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 16
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 16
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 16
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]	FSH - Week 24
NCT03933618 (95) [back to overview]	SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]	FSH - Week 24
NCT03933618 (95) [back to overview]	FSH - Week 8
NCT03933618 (95) [back to overview]	SHBG - Screen
NCT03933618 (95) [back to overview]	FSH - Week 8
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Screen
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Week 16
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Week 16
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Week 24
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Week 24
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Week 24
NCT03933618 (95) [back to overview]	IIEF (International Index of Erectile Function) Score - Week 8
NCT03933618 (95) [back to overview]	LH - Screen
NCT03933618 (95) [back to overview]	LH - Screen
NCT03933618 (95) [back to overview]	LH - Week 16
NCT03933618 (95) [back to overview]	LH - Week 16
NCT03933618 (95) [back to overview]	LH - Week 24
NCT03933618 (95) [back to overview]	LH - Week 24
NCT03933618 (95) [back to overview]	LH - Week 24
NCT03933618 (95) [back to overview]	LH - Week 8
NCT03933618 (95) [back to overview]	SHBG - Screen
NCT03933618 (95) [back to overview]	SHBG - Week 16
NCT03933618 (95) [back to overview]	SHBG - Week 16
NCT03933618 (95) [back to overview]	SHBG - Week 24
NCT03933618 (95) [back to overview]	SHBG - Week 24
NCT03933618 (95) [back to overview]	SHBG - Week 24
NCT03933618 (95) [back to overview]	SHBG - Week 8
NCT03933618 (95) [back to overview]	SHBG - Week 8
NCT03933618 (95) [back to overview]	FSH - Week 16
NCT03933618 (95) [back to overview]	FSH - Screen
NCT03933618 (95) [back to overview]	FSH - Screen
NCT03933618 (95) [back to overview]	Free Testosterone - Week 8
NCT03933618 (95) [back to overview]	FSH - Week 16
NCT03933618 (95) [back to overview]	Free Testosterone - Week 8
NCT03933618 (95) [back to overview]	Free Testosterone - Week 8
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Week 8
NCT03933618 (95) [back to overview]	Free Testosterone - Week 8
NCT03933618 (95) [back to overview]	Free Testosterone - Week 24
NCT03933618 (95) [back to overview]	Free Testosterone - Week 24
NCT03933618 (95) [back to overview]	Free Testosterone - Week 24
NCT03933618 (95) [back to overview]	Free Testosterone - Week 24
NCT03933618 (95) [back to overview]	Free Testosterone - Week 24
NCT03933618 (95) [back to overview]	Free Testosterone - Week 16
NCT03933618 (95) [back to overview]	Free Testosterone - Week 16
NCT03933618 (95) [back to overview]	Free Testosterone - Week 16
NCT03933618 (95) [back to overview]	Free Testosterone - Screen
NCT03933618 (95) [back to overview]	Free Testosterone - Screen
NCT03933618 (95) [back to overview]	Free Testosterone - Screen
NCT03933618 (95) [back to overview]	Estradiol - Week 8
NCT03933618 (95) [back to overview]	Estradiol - Week 8
NCT03933618 (95) [back to overview]	Estradiol - Week 8
NCT03933618 (95) [back to overview]	Estradiol - Week 24
NCT03933618 (95) [back to overview]	Estradiol - Week 24
NCT03933618 (95) [back to overview]	Estradiol - Week 24
NCT03933618 (95) [back to overview]	Estradiol - Week 16
NCT03933618 (95) [back to overview]	Estradiol - Week 16
NCT03933618 (95) [back to overview]	Estradiol - Week 16
NCT03933618 (95) [back to overview]	Estradiol - Screen
NCT03933618 (95) [back to overview]	Estradiol - Screen
NCT03933618 (95) [back to overview]	Normalized Testosterone - Week 16
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Week 24
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Week 24
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Week 24
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Week 16
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Week 16
NCT03933618 (95) [back to overview]	EHS (Erectile Hardness Score) - Screen
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
NCT03933618 (95) [back to overview]	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
NCT03933618 (95) [back to overview]	FSH - Week 24
NCT04059484 (13) [back to overview]	Overall Survival (OS)
NCT04059484 (13) [back to overview]	Duration of Response (DOR)
NCT04059484 (13) [back to overview]	Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score
NCT04059484 (13) [back to overview]	Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value
NCT04059484 (13) [back to overview]	Percentage of Participants With Clinical Benefit
NCT04059484 (13) [back to overview]	Progression Free Survival (PFS) According to Estrogen Receptor 1 Gene (ESR1) Mutation Status
NCT04059484 (13) [back to overview]	Pharmacokinetics: Plasma Concentrations of Amcenestrant
NCT04059484 (13) [back to overview]	Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
NCT04059484 (13) [back to overview]	Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
NCT04059484 (13) [back to overview]	Within-Participant Steady State Ctrough of Amcenestrant
NCT04059484 (13) [back to overview]	Progression Free Survival (PFS)
NCT04059484 (13) [back to overview]	Percentage of Participants With Objective Response
NCT04059484 (13) [back to overview]	Percentage of Participants With Disease Control
NCT04075604 (11) [back to overview]	Objective Response Rate (ORR)
NCT04075604 (11) [back to overview]	The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
NCT04075604 (11) [back to overview]	The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
NCT04075604 (11) [back to overview]	The Number of Participants Experiencing Immune-Related Adverse Events (AEs)
NCT04075604 (11) [back to overview]	The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
NCT04075604 (11) [back to overview]	The Number of Participants Experiencing Serious Adverse Events (SAEs)
NCT04075604 (11) [back to overview]	The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
NCT04075604 (11) [back to overview]	The Number of Participants Experiencing Adverse Events (AEs)
NCT04075604 (11) [back to overview]	The Number of Participants Deaths
NCT04075604 (11) [back to overview]	Pathological Complete Response (pCR) Rate
NCT04075604 (11) [back to overview]	Breast Conserving Surgery (BCS) Rate
NCT04436744 (12) [back to overview]	Number of Participants With Adverse Events (AEs) With Severity Determined in Accordance With National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
NCT04436744 (12) [back to overview]	Number of Participants With Shifts in Hematology Test Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline
NCT04436744 (12) [back to overview]	Change From Baseline in Systolic Blood Pressure Over Time
NCT04436744 (12) [back to overview]	Change From Baseline in Respiratory Rate Over Time
NCT04436744 (12) [back to overview]	Change From Baseline in Pulse Rate Over Time
NCT04436744 (12) [back to overview]	Number of Participants With Shifts in Blood Chemistry Parameters From NCI-CTCAE Grade 0-2 at Baseline to Grade 3-4 at Post-baseline
NCT04436744 (12) [back to overview]	Change From Baseline in Body Temperature Over Time
NCT04436744 (12) [back to overview]	Relative Percent Change in Ki67 Scores From Baseline to Week 2
NCT04436744 (12) [back to overview]	Overall Response Rate (ORR) by Ultrasound as Determined by the Investigator
NCT04436744 (12) [back to overview]	Complete Cell Cycle Arrest (CCCA) Rate at Week 2
NCT04436744 (12) [back to overview]	Plasma Concentration of Giredestrant at Specified Timepoints
NCT04436744 (12) [back to overview]	Change From Baseline in Diastolic Blood Pressure Over Time

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00005908)
Timeframe: 6 years

Intervention	Participants (Number)
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine	9
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine	20

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Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models

Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out. (NCT00005908)
Timeframe: 6 years

Intervention	Participants (Number)
	Responders	Non-responders
Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine	8	13

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Complementary Deoxyribonucleic Acid (cDNA) Expression

Intervention	Participants (Number)
	Responders	Non-responders
Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine	8	2
Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine	7	13

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Overall Clinical Response Rate

Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module. (NCT00005908)
Timeframe: 6 years

Intervention	Percentage of participants (Number)
	Complete Response	Partial Response	Complete pathologic response
Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine	31	59	10

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Percentage of Participants With Best Tumor Response at 24 Months

Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study. (NCT00022672)
Timeframe: 24 Months

Intervention	Percentage of participants (Number)
	Complete Response	Partial Response	Stable Disease	Progressive Disease	Response not assessed
Anastrozole	0.0	6.8	38.4	49.3	5.5
Trastuzumab + Anastrozole	0.0	20.3	37.8	40.5	1.4

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Number of Participants With Adverse Events

Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring. (NCT00022672)
Timeframe: Throughout the Study (Up to 5 years)

Intervention	Participants (Number)
Trastuzumab + Anastrozole	90
Anastrozole	68

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Overall Survival at 24 Months

Overall Survival is defined as the number of days from randomization to death. (NCT00022672)
Timeframe: 24 Months

Intervention	Months (Median)
Trastuzumab + Anastrozole	28.5
Anastrozole	23.9

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Percentage of Participants With Overall Tumor Response at 24 Months

Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response. (NCT00022672)
Timeframe: 24 Months

Intervention	Percentage of participants (Number)
Trastuzumab + Anastrozole	20.3
Anastrozole	6.8

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Percentage of Participants With Overall Tumor Response at End of Study

Intervention	Percentage of participants (Number)
Trastuzumab + Anastrozole	22.3
Anastrozole	8.7

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Percentage of Participants With Two-Year Survival

(NCT00022672)
Timeframe: 24 Months

Intervention	Percentage of participants (Number)
Trastuzumab + Anastrozole	52.4
Anastrozole	45.2

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Time to Response at 24 Months

Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted. (NCT00022672)
Timeframe: 24 Months

Intervention	Months (Median)
Trastuzumab + Anastrozole	2.0
Anastrozole	2.0

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Time to Response at End of Study

Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted. (NCT00022672)
Timeframe: End of Study (Up to 5 years)

Intervention	Months (Median)
Trastuzumab + Anastrozole	2.4
Anastrozole	2.1

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Duration of Response at End of Study

Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up. (NCT00022672)
Timeframe: End of Study (Up to 5 years)

Intervention	Months (Median)
Trastuzumab + Anastrozole	12.3
Anastrozole	8.2

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Progression Free Survival (PFS)

PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented. (NCT00022672)
Timeframe: 24 Months, End of Study (Up to 5 years)

Intervention	Months (Median)
	24 Months	End of Study
Anastrozole	2.4	2.9
Trastuzumab + Anastrozole	4.8	5.8

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Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline

"Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.~The percentage of participants in the following categories:~Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline." (NCT00022672)
Timeframe: Baseline, Final Visit (Up to 24 Months)

Intervention	Percentage of participants (Number)
	Improved	No Change	Worse
Anastrozole	4.1	64.4	31.5
Trastuzumab + Anastrozole	10.3	67.6	22.1

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Percentage of Participants With Clinical Benefit

Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response. (NCT00022672)
Timeframe: 24 Months, End of Study (Up to 5 years)

Intervention	Percentage of participants (Number)
	24 Months	End of Study
Anastrozole	27.9	30.8
Trastuzumab + Anastrozole	42.7	45.6

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Percentage of Participants With Best Tumor Response at End of Study

Intervention	Percentage of participants (Number)
	Complete Response	Partial Response	Stable Disease	Progressive Disease	Response not assessed
Anastrozole	3.8	4.8	40.4	46.2	4.8
Trastuzumab + Anastrozole	1.0	21.4	47.6	28.1	1.9

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Duration of Response at 24 Months

Intervention	Months (Median)
Trastuzumab + Anastrozole	9.5
Anastrozole	10.0

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Percentage of Patients Alive and Disease-free

Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	77.9
Group 2: Anastrozole + Tamoxifen Placebo	82.7

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Percentage of Patients Free From Breast Cancer

Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	89.1
Group 2: Anastrozole + Tamoxifen Placebo	93.1

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Percentage of Patients Free From Contralateral Breast Cancer

Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	94.7
Group 2: Anastrozole + Tamoxifen Placebo	97.0

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Percentage of Patients Free From Invasive Breast Cancer

Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	93.3
Group 2: Anastrozole + Tamoxifen Placebo	96.4

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Percentage of Patients Free From Ipsilateral Recurrence

Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	94.6
Group 2: Anastrozole + Tamoxifen Placebo	96.4

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Percentage of Patients Free From Non-breast Secondary Cancer

Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	91.5
Group 2: Anastrozole + Tamoxifen Placebo	91.9

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Percentage of Patients Alive (Overall Survival)

Percentage of patients alive. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	92.1
Group 2: Anastrozole + Tamoxifen Placebo	92.5

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Quality of Life-Short Form 12 (SF-12) Physical Health Component Score

The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health. (NCT00053898)
Timeframe: 5 years

Intervention	units on a scale (Mean)
Group 1: Tamoxifen + Anastrozole Placebo	46.20
Group 2: Anastrozole + Tamoxifen Placebo	45.38

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Quality-adjusted Survival Time

The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method. (NCT00053898)
Timeframe: 10 years

Intervention	months (Mean)
Group 1: Tamoxifen + Anastrozole Placebo	104.4
Group 2: Anastrozole + Tamoxifen Placebo	102.9

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Percentage of Patients Free From Osteoporotic Fractures

Percentage of patients free from fractures of the hip, spine, and wrist. (NCT00053898)
Timeframe: 10 years

Intervention	percentage of participants event-free (Number)
Group 1: Tamoxifen + Anastrozole Placebo	96.0
Group 2: Anastrozole + Tamoxifen Placebo	95.3

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Clinical Benefit Rate

Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included. (NCT00057941)
Timeframe: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years

Intervention	percentage of participants (Number)
Anastrozole and ZD1839	44
Fulvestrant and ZD1839	41

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Overall Survival: Percentage of Participants Alive at 5 Years

Overall survival is defined as the time from randomization to the time of death from any cause. (NCT00066573)
Timeframe: 5 years

Intervention	Percentage of Participants (Number)
Exemestane	92
Anastrozole	92

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Clinical Fracture Rate: Number of Participants With Bone Fractures.

Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures. (NCT00066573)
Timeframe: 8 years

Intervention	Participants (Count of Participants)
Exemestane	358
Anastrozole	354

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Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence

Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver. (NCT00066573)
Timeframe: 5 years

Intervention	Participants (Count of Participants)
Exemestane	157
Anastrozole	164

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Event-free Survival

Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause. (NCT00066573)
Timeframe: 5 years

Intervention	percentage of participants (Number)
Exemestane	88
Anastrozole	89

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Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable >= 24 weeks (NCT00075764)
Timeframe: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.

Intervention	percentage of participants (Number)
Arm I Anastrozole	70
Arm II Anastrozole and Fulvestrant	73

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Overall Survival

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact. (NCT00075764)
Timeframe: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.

Intervention	months (Median)
Arm I Anastrozole	41.3
Arm II Anastrozole and Fulvestrant	47.7

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Time to Tumor Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact. (NCT00075764)
Timeframe: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.

Intervention	months (Median)
Arm I Anastrozole	13.5
Arm II Anastrozole and Fulvestrant	15.0

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Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal) (NCT00075764)
Timeframe: Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.

Intervention	Participants (Number)
	ALT, SGPT (serum glutamic pyruvic transaminase)	AST, SGOT	Albumin, serum-low (hypoalbuminemia)	Alkaline phosphatase	Anorexia	Bilirubin (hyperbilirubinemia)	CNS cerebrovascular ischemia	Calcium, serum-high (hypercalcemia)	Cataract	Confusion	Constipation	Dehydration	Diarrhea	Dizziness	Dyspnea (shortness of breath)	Edema: limb	Fatigue (asthenia, lethargy, malaise)	Febrile neutropenia	Fracture	Glucose, serum-high (hyperglycemia)	Hemoglobin	Hemolysis	Hot flashes/flushes	Hypertension	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	Infection with unknown ANC - Urinary tract NOS	Insomnia	Joint-effusion	Leukocytes (total WBC)	Lymphopenia	Memory impairment	Mood alteration - agitation	Mood alteration - anxiety	Mood alteration - depression	Mucositis/stomatitis (functional/symp) - Pharynx	Muscle weakness, not d/t neuropathy - body/general	Nausea	Neurology-Other (Specify)	Neuropathy: sensory	Neutrophils/granulocytes (ANC/AGC)	Pain - Abdomen NOS	Pain - Back	Pain - Bone	Pain - Breast	Pain - Buttock	Pain - Chest wall	Pain - Chest/thorax NOS	Pain - Extremity-limb	Pain - Head/headache	Pain - Joint	Pain - Muscle	Pain - Neck	Pain - Pelvis	Pain-Other (Specify)	Platelets	Rash/desquamation	Sodium, serum-low (hyponatremia)	Speech impairment (e.g., dysphasia or aphasia)	Sudden death	Syncope (fainting)	Thrombosis/embolism (vascular access-related)	Thrombosis/thrombus/embolism	Tinnitus	Tumor flare	Urticaria (hives, welts, wheals)	Vomiting	Weight gain
Arm I Anastrozole	1	3	1	1	0	1	0	1	1	0	1	1	2	1	1	1	7	1	1	1	1	1	2	2	1	1	0	0	0	0	3	1	0	1	0	1	1	3	1	1	0	1	5	1	1	1	0	1	0	1	5	3	0	0	2	2	1	0	1	0	0	3	6	0	0	0	3	0
Arm II Anastrozole and Fulvestrant	1	1	1	0	1	0	2	0	1	1	1	1	1	2	1	1	9	0	2	2	3	1	7	1	0	1	2	1	2	1	3	0	1	0	3	0	0	1	0	0	2	2	7	1	0	0	1	1	3	0	7	0	1	3	1	2	1	1	0	1	1	1	7	1	2	1	2	1

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Change in Growth Rate (cm/Year)

Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year). (NCT00094328)
Timeframe: Assessed after 12 months treatment

Intervention	cm/year (Mean)
Open Label Bicalutamide With Anastrozole	-1.62

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Change in Growth Rate (SD Units)

Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score). (NCT00094328)
Timeframe: Assessed after 12 months treatment

Intervention	SD units (Mean)
Open Label Bicalutamide With Anastrozole	-0.07

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Change in Growth Rate (SD Units)

Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period. (NCT00094328)
Timeframe: Assessed after 6 months treatment

Intervention	SD units (Mean)
Open Label Bicalutamide With Anastrozole	-0.14

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Change in Predicted Adult Height (PAH)

Radiographs are used to assess the bone age, the change in predicted adult height (PAH) is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH is be calculated by subtracting the PAH at baseline from the PAH at 12 months. (NCT00094328)
Timeframe: Assessed after 12 months treatment

Intervention	cm (Mean)
Open Label Bicalutamide With Anastrozole	6.21

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Change in Average Testicular Volume

Testicular volume of both testes was measured using either ultrasound or an orchidometer. Testicular volume was measured at baseline and at 6 and 12 months. The change in testicular volume from baseline was calculated for the left and right testicle as well as the average across both testes by subtracting the baseline volume from the volumes at 6 and 12 months within each patient. (NCT00094328)
Timeframe: Assessed after 6 and 12 months of treatment

Intervention	mL (Mean)
	After 6 months treatment	After 12 months treatment
Open Label Bicalutamide With Anastrozole	1.46	2.69

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Change in Bone Age Maturation Rate (cm/Year)

Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation after 6 months of treatment was calculated relative to the rate of change in bone age during the ≥ 6 months pre-study period. (NCT00094328)
Timeframe: Assessed after 6 and 12 months treatment

Intervention	cm/year (Mean)
	After 6 months treatment	After 12 months treatment
Open Label Bicalutamide With Anastrozole	-2.03	-2.29

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Change in Bone Age to Chronological Age Ratio

Change in bone age to chronological age ratio after 6 and 12 months treatment relative to the baseline ratio for all patients. (NCT00094328)
Timeframe: Assessed after 6 and 12 months of treatment

Intervention	Ratio (Mean)
	After 6 months treatment	After 12 months treatment
Open Label Bicalutamide With Anastrozole	-0.09	-0.24

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Change in Growth Rate (cm/Year)

Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period. (NCT00094328)
Timeframe: Assessed after 6 months treatment

Intervention	cm/year (Mean)
Open Label Bicalutamide With Anastrozole	-0.70

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Number of Patients With Height Between 5th and 95th Percentile

The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment. (NCT00094328)
Timeframe: Assessed after 3, 6, 9 and 12 months of treatment

Intervention	Participants (Number)
	After 3 months treatment	After 6 months treatment	After 9 months treatment	After 12 months treatment
Open Label Bicalutamide With Anastrozole	3	3	3	3

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Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism

"Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more.~Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point." (NCT00104572)
Timeframe: 1 year

Intervention	score on a scale (Mean)
Transdermal Testosterone	-0.05
Aromatase Inhibitor	0.15
Placebo	-0.11

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Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function

"rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo.~Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point." (NCT00104572)
Timeframe: 1 year

Intervention	cc (Mean)
Transdermal Testosterone	4.5
Aromatase Inhibitor	-1.66
Placebo	-1.05

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Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density

bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo (NCT00104572)
Timeframe: 1 year

Intervention	g/cm2 (Mean)
Transdermal Testosterone	0.042
Aromatase Inhibitor	0.008
Placebo	0.047

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Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release

Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo (NCT00104572)
Timeframe: 1 year

Intervention	ng/ml/8h (Mean)
Transdermal Testosterone	5.8
Aromatase Inhibitor	10
Placebo	7.7

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Knee Cartilage Volume

change in medial and lateral articular tibial cartilage volume over two years (NCT00111241)
Timeframe: Baseline, two years

Intervention	mm³ (Mean)
Women With Breast Cancer	2042
Control	1971

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Knee Subchondral Bone Expansion

change in subchondral bone expansion area over two years (NCT00111241)
Timeframe: Baseline, Two years

Intervention	mm² (Mean)
Women With Breast Cancer	2020
Healthy Control Group	1992

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Change in Lean Body Mass

(NCT00136695)
Timeframe: Baseline and 1 year

Intervention	grams (Mean)
Anastrozole	-2000
Placebo	-1500

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Overall Survival (OS)

OS is defined as time from the date of randomization to the date of death. (NCT00143390)
Timeframe: Up to 2008 days of the treatment

Intervention	months (Median)
Exemestane	NA
Anastrozole	60.1

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Time to Progression (TTP) - Expert Evaluation Committee Assessment

Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition). (NCT00143390)
Timeframe: Up to 2008 days of the treatment

Intervention	months (Median)
Exemestane	13.8
Anastrozole	11.1

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Time to Progression (TTP) - Investigators Assessment

Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition). (NCT00143390)
Timeframe: Up to 2008 days of the treatment

Intervention	months (Median)
Exemestane	13.8
Anastrozole	13.7

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Time to Treatment Failure (TTF)

TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. (NCT00143390)
Timeframe: Up to 2008 days of the treatment

Intervention	months (Median)
Exemestane	13.6
Anastrozole	11.1

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Number of Participants With Clinical Benefit - Investigator Assessment

Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD (NCT00143390)
Timeframe: Up to 2008 days of the treatment

Intervention	participants (Number)
	CR	PR	long-term SD	Clinical Benefit (CR+PR+long-term SD)
Anastrozole	3	47	49	99
Exemestane	2	56	41	99

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Number of Participants With Objective Response - Investigators Assessment

Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR. (NCT00143390)
Timeframe: Up to 2008 days of the treatment

Intervention	participants (Number)
	CR	PR	Objective Response (CR + PR)
Anastrozole	3	47	50
Exemestane	2	56	58

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Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.

S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better. (NCT00179517)
Timeframe: 3 month average

Intervention	Scores on a Scale (Mean)
	Change in S-Score	Reynolds Questionnaire Change in R-Interest	Reynolds Questionnaire Change in R-Activity	Reynolds Questionnaire Change in R-Satisfaction	Reynolds Questionnaire Change in R-Function
Depotestosterone Plus Anastrozole (T-A)	3.7	2.4	11.1	2.4	-1.7
Depotestosterone Plus Placebo (T-P)	2.5	1.5	4.7	2.1	-1.3

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The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.

Bioavailable testosterone and estradiol levels were measured once a month over the three month study in subjects taking anastrozole and subjects taking placebo. The bioavailable testosterone and estradiol levels for the three months were averaged for each subject. The ratio between the average bioavailable testosterone level and average estradiol levels were reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	Ratio (Mean)
Depotestosterone Plus Anastrozole (T-A)	145.47
Depotestosterone Plus Placebo (T-P)	12.78

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Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).

Bioavailable testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	ng/dl (Mean)
Depotestosterone Plus Anastrozole (T-A)	150.9
Depotestosterone Plus Placebo (T-P)	161.7

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Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).

The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T-A) and depotestosterone plus placebo (T-P) were reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	number of seizures (Mean)
Depotestosterone Plus Anastrozole (T-A)	-2.0
Depotestosterone Plus Placebo (T-P)	-2.9

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Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).

Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged for the three months. The ratio between the average estradiol levels and average luteinizing hormone levels were reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	Ratio (Mean)
Depotestosterone Plus Anastrozole (T-A)	9.31
Depotestosterone Plus Placebo (T-P)	53.80

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Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).

Estradiol levels were measured once a month over the three month study in subjects taking anastrozole (T-A) and in subjects taking placebo (T-P). The average change in estradiol levels was reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	pg/mL (Mean)
Depotestosterone Plus Anastrozole (T-A)	-14.6
Depotestosterone Plus Placebo (T-P)	8.6

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Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).

Bioavailable Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged for the three months. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	Ratio (Mean)
Depotestosterone Plus Anastrozole (T-A)	450.24
Depotestosterone Plus Placebo (T-P)	482.65

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Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).

Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	Scores on a scale (Mean)
	Change in Depression (Beck Depression Inventory II	Change in Vigor	Change in Fatigue	Change in Depression (POMS-D)	Change in Anxiety (POMS-T)	Change in Anger (POMS A)	Change in Confusion (POMS-C)
Depotestosterone Plus Anastrozole (T-A)	-5.3	4.6	-6.0	-5.6	-3.0	-2.4	-2.7
Depotestosterone Plus Placebo (T-P)	-6.4	4.8	-4.5	-6.7	-4.2	-2.6	-2.7

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The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo

The proportion of men who achieve normalization of sexual scores (scores greater than or equal to 16/20) on anastrozole (T-A) and those on placebo (T-P) are reported. Both Men who achieve normalization of sexual scores and those who did not achieve normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group. Sexual scores were gathered once per month for three months with the average of the three months reported. (NCT00179517)
Timeframe: Assessed for 3 months

Intervention	Participants (Count of Participants)
	Normalization of S-Score	No Normalization of S-Score
Depotestosterone Plus Anastrozole (T-A)	13	5
Depotestosterone Plus Placebo (T-P)	9	10

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Clinical Benefit Rate

"The overall clinical benefit rate of goserelin followed by anastrozole was evaluated, as determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~SD = No significant change in measurable or evaluable disease for at least 4 weeks.~All measurements by ruler or calipers." (NCT00186121)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Anastrozole + Goserelin	71.9

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Objective Response Rate (ORR)

"ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~All measurements by ruler or calipers." (NCT00186121)
Timeframe: 3 months

Intervention	percentage of participants (Number)
Anastrozole + Goserelin	37.5

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Overall Survival (OS)

Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole. (NCT00186121)
Timeframe: up to 63 months

Intervention	months (Median)
Anastrozole + Goserelin	NA

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Serious Adverse Events

The toxicity of the treatment regimen of goserelin followed by anastrozole is estimated by the rate of Serious Adverse Events (SAEs) that occurred during the course of the study. (NCT00186121)
Timeframe: 6 months

Intervention	Serious Adverse Events (SAEs) (Number)
Anastrozole + Goserelin	0

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Time-to-Progression (TTP)

"Time-to-progression (TTP) was assessed as the median observed in the participant group.~Progression of disease was considered, per protocol, to be ≤ 25% increase in the area of any malignant lesion greater than 2 square cm, or ≤ 25% increase in the sum of the products of the longest perpendicular diameters of individual lesions in a given organ, when compared to baseline values or after therapeutic response." (NCT00186121)
Timeframe: up to 63 months

Intervention	months (Median)
Anastrozole + Goserelin	8.3

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Estradiol Suppression

Plasma estradiol determinations were performed at baseline, 1 month, 3 months, and 6 months using the Coat-A-Count Estradiol competitive binding assay system, which has a calibrated range for estradiol of 20 to 3,600 pg/mL with an analytical sensitivity of 10 pg/mL. (NCT00186121)
Timeframe: 6 months

Intervention	pg/mL estradiol (Mean)
	Mean at Baseline	Mean at 1 month treatment	Mean at 3 months treatment	Mean at 6 months treatment
Anastrozole + Goserelin	74.7	20.8	18.7	14.8

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Response Rates

"The numbers of participants with metastatic breast cancer experiencing Complete Response (CR); Partial Response (PR); or Stable Disease (SD) after treatment with goserelin followed by anastrozole are reported.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~SD = No significant change in measurable or evaluable disease for at least 4 weeks.~All measurements by ruler or calipers." (NCT00186121)
Timeframe: 6 months

Intervention	Participants (Count of Participants)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)
Anastrozole + Goserelin	1	11	11

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Ovulation Rate in Cycle 1

Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy). (NCT00213148)
Timeframe: Up to 1 month

Intervention	percentage of subjects (Number)
Clomiphene Citrate 50 mg	64.9
Anastrozole 1 mg	30.4
Anastrozole 5 mg	36.8
Anastrozole 10 mg	35.9

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Number of Subjects With Clinical Pregnancy in Cycle 1

Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity. (NCT00213148)
Timeframe: Up to 1 month

Intervention	subjects (Number)
Clomiphene Citrate 50 mg	10
Anastrozole 1 mg	4
Anastrozole 5 mg	7
Anastrozole 10 mg	0

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Number of Participants With Adverse Events

Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0 (NCT00217399)
Timeframe: 1 year

Intervention	participants (Number)
Sorefenib and Anastrozole	35

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Tumor Marker Analysis

Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-). (NCT00217399)
Timeframe: 1 year

Intervention	participants (Number)
Circulating Endothelial Cells	14

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Complete Response + Partial Response + Stable Disease > 24 Weeks

"Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking.~A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks." (NCT00217399)
Timeframe: 24 weeks

Intervention	participants (Number)
Sorafenib and Anastrozole	35

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Time to Development of Contra Lateral Breast Cancer

Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast. (NCT00248170)
Timeframe: 84 months

Intervention	Months (Median)
Letrozole	NA
Anastrozole	NA

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Distant Disease-free Survival

Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause. (NCT00248170)
Timeframe: 84 months

Intervention	Months (Median)
Letrozole	NA
Anastrozole	NA

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Overall Survival

Overall survival was defined as the time from the date of randomization to the date of death from any cause. (NCT00248170)
Timeframe: 84 months

Intervention	Months (Median)
Letrozole	NA
Anastrozole	NA

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Percentage of Participants Who Experienced Clinical Fracture Events

The incidence of clinical fractures was analyzed. (NCT00248170)
Timeframe: 84 months

Intervention	Percentage of participants (Number)
Letrozole	9.3
Anastrozole	8.1

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Time to Development of Distant Metastases

Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast. (NCT00248170)
Timeframe: 84 months

Intervention	Months (Median)
Letrozole	NA
Anastrozole	NA

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Change From Baseline in Serum Lipid Profiles

Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated. (NCT00248170)
Timeframe: baseline, 6, 12, 24, 36, 48 and 60 months

Intervention	mg/dL (Mean)
	6 months	12 months	24 months	36 months	48 months	60 months
Anastrozole	5.553	5.511	5.436	5.427	5.366	5.368
Letrozole	5.643	5.569	5.508	5.429	5.395	5.375

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Percentage of Participants Who Experienced Cardiovascular Events

The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed. (NCT00248170)
Timeframe: 84 months

Intervention	Percentage of participants (Number)
	Ischemic heart disease	Cardiac failures	Cerebrovascular accidents	Thromboembolic events
Anastrozole	1.5	0.7	1.5	1.2
Letrozole	2.4	1.5	1.6	1.2

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Disease Free Survival

Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause. (NCT00248170)
Timeframe: 84 months

Intervention	Months (Median)
Letrozole	NA
Anastrozole	NA

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Percentage of Evaluable Participants With Objective Response Rate (ORR)

No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions) (NCT00256698)
Timeframe: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Intervention	Percentage of evaluable participants (Number)
Fulvestrant + Anastrozole	31.8
Anastrozole	33.6

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Percentage of Clinical Benefit Rate (CBR) Responders

No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression) (NCT00256698)
Timeframe: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Intervention	Percentage of participants (Number)
Fulvestrant + Anastrozole	55.0
Anastrozole	55.1

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Overall Survival (OS)

Overall survival is equivalent to time to death. Time from randomisation until the date of death (NCT00256698)
Timeframe: All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.

Intervention	months (Median)
Fulvestrant + Anastrozole	37.8
Anastrozole	38.2

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Duration of Response (DoR)

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders (NCT00256698)
Timeframe: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Intervention	months (Median)
Fulvestrant + Anastrozole	22.3
Anastrozole	18.2

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Duration of Clinical Benefit (DoCB)

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders (NCT00256698)
Timeframe: RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Intervention	months (Median)
Fulvestrant + Anastrozole	18.5
Anastrozole	18.1

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Time to Treatment Failure (TTF)

Time from randomisation until the date of discontinuation of randomised treatment for any reason (NCT00256698)
Timeframe: From randomisation until data cut-off on 30th April 2009

Intervention	months (Median)
Fulvestrant + Anastrozole	12.4
Anastrozole	11.4

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Time to Progression (TTP)

"RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve respond, stay the same stableor worsen progression during treatments." (NCT00256698)
Timeframe: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

Intervention	months (Median)
Fulvestrant + Anastrozole	10.8
Anastrozole	10.2

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Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.

For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 (NCT00259090)
Timeframe: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)

Intervention	Percentage change from baseline (Mean)
Fulvestrant	-31
Fulvestrant + Anastrozole	-38
Anastrozole	-38

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Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.

For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 (NCT00259090)
Timeframe: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)

Intervention	Percentage change from baseline (Mean)
Fulvestrant	-37
Fulvestrant + Anastrozole	-38
Anastrozole	-7

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Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.

For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100 (NCT00259090)
Timeframe: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)

Intervention	Percentage change from baseline (Mean)
Fulvestrant	-62
Fulvestrant + Anastrozole	-68
Anastrozole	-75

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Toxicity (Cohort A)

Incidence of the most common grade 3+ toxicities reported to be probably, possibly, or definitely related to treatment as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (Cohort A) At each treatment evaluation, the type, severity, and attribution of each adverse event reported will be assessed using the NCI-CTCAE definitions. For each treatment, the percentage of patients who developed a severe (grade 3+) toxicity considered possibly, probably or definitively related to treatment will be determined. (NCT00265759)
Timeframe: Up to 30 days after drug therapy

Intervention	percentage of patients (Number)
	Fatigue	Hot flashes/flushes	Joint pain
Cohort A Arm I: Exemestane	2	2	2
Cohort A Arm II: Letrozole	2	4	3
Cohort A Arm III: Anastrozole	3	2	2

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Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)

The rate (percentage) of improved surgical outcome for patients considered marginal for breast conservation surgery prior to therapy for Cohort A is reported below for each treatment arm. Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome. (NCT00265759)
Timeframe: At time of surgery up to 18 weeks

Intervention	percentage of improved surgical outcome (Number)
Cohort A Arm I: Exemestane	85.2
Cohort A Arm II: Letrozole	77.4
Cohort A Arm III: Anastrozole	86.4

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Clinical Response (Complete or Partial Response) Rate (Cohort A)

The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion. (NCT00265759)
Timeframe: Up to 18 weeks

Intervention	percentage of patients (Number)
Cohort A Arm I: Exemestane	62.9
Cohort A Arm II: Letrozole	74.8
Cohort A Arm III: Anastrozole	69.1

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Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)

The primary aim is to assess the anti-tumor effect in terms of pathologic CR rates of neo-adjuvant chemotherapy in patients with T2-T4c, any N, M0 breast cancer (by clinical staging) who are endocrine therapy resistant (that is, their Ki-67 level is >10 after 2-4 week of neo-adjuvant endocrine therapy alone). The pCR rate (percentage) for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy. (NCT00265759)
Timeframe: Up to 18 weeks

Intervention	percentage of patients (Number)
Cohort B Arm II: Week 2 Ki67 > 10%	5.7

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Rate of Lymph Node Involvement (LNI) (Cohort A)

For those patients who undergo a sentinel lymph node dissection or an axillary lymph node dissection (at least 6 nodes examined with Hematoxylin & Eosin Staining), the LNI rate (percentage) is defined as 100 times the proportion of eligible patients randomized to that treatment with at least one positive node. For each neo-adjuvant endocrine treatment, a 95% binomial confidence interval will be constructed for its true LNI rate. (NCT00265759)
Timeframe: At time of surgery up to 18 weeks

Intervention	percentage of patients (Number)
Cohort A Arm I: Exemestane	41.1
Cohort A Arm II: Letrozole	48.2
Cohort A Arm III: Anastrozole	44.1

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The Pathologic Complete Response (pCR) Rate (Cohort A)

The pathologic complete response is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes. The pathologic complete response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgical specimen is such that there is no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the pCR between these 2 treatments. (NCT00265759)
Timeframe: At time of surgery up to 18 weeks

Intervention	percentage of patients (Number)
Cohort A Arm I: Exemestane	1.7
Cohort A Arm II: Letrozole	0.0
Cohort A Arm III: Anastrozole	0.0

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Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)

Rate (percentage) of Improved surgical outcome for patients designated as candidates for mastectomy prior to therapy (Cohort A). Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome. (NCT00265759)
Timeframe: At time of surgery up to 18 weeks

Intervention	percentage of patients (Number)
Cohort A Arm I: Exemestane	48.1
Cohort A Arm II: Letrozole	42.1
Cohort A Arm III: Anastrozole	60.0

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Overall Survival

Time from randomization to death (any cause) (NCT00274469)
Timeframe: From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled.

Intervention	Month (Median)
Fulvestrant 500 mg	54.1
Anastrozole 1 mg	48.4

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Time to Progression

Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported. (NCT00274469)
Timeframe: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Intervention	Day (Median)
Fulvestrant 500 mg	NA
Anastrozole 1 mg	381

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Time to Progression (Investigator Assessed)

Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study. (NCT00274469)
Timeframe: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

Intervention	Day (Median)
Fulvestrant 500 mg	712
Anastrozole 1 mg	400

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Time to Treatment Failure

Time from randomization to treatment discontinuation (NCT00274469)
Timeframe: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

Intervention	Day (Median)
Fulvestrant 500 mg	536
Anastrozole 1 mg	387

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Clinical Benefit Rate

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB. (NCT00274469)
Timeframe: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Intervention	Percentage of Participants (Number)
Fulvestrant 500 mg	72.5
Anastrozole 1 mg	67.0

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Objective Response Rate

For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR. (NCT00274469)
Timeframe: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Intervention	Percentage of Participants (Number)
Fulvestrant 500 mg	36.0
Anastrozole 1 mg	35.5

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Time to Contralateral Breast Cancer

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free. (NCT00295620)
Timeframe: Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years

Intervention	Years (Median)
Arm A: Anastrozol	NA
Arm B: Anastrozol	NA

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Overall Survival After Prolonged Endocrine Treatment

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival. (NCT00295620)
Timeframe: Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years

Intervention	Years (Median)
Arm A: Anastrozol	NA
Arm B: Anastrozol	NA

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Disease-free Survival After Prolonged Endocrine Treatment

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival. (NCT00295620)
Timeframe: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years

Intervention	Years (Median)
Arm A: Anastrozol	NA
Arm B: Anastrozol	NA

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Time to Secondary Carcinoma

To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free. (NCT00295620)
Timeframe: Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years

Intervention	Years (Median)
Arm A: Anastrozol	NA
Arm B: Anastrozol	NA

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Time to First Clinical Fracture

To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization). (NCT00295620)
Timeframe: Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.

Intervention	Years (Median)
Arm A: Anastrozol	NA
Arm B: Anastrozol	NA

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5-year Distant Recurrence-free Interval

Distant recurrence-free interval (DRFI) is defined as time from date of randomization or registration to the date of distant recurrence of breast cancer, or of death with distant recurrence, if death is the first manifestation of distant recurrence. The distribution of DRFI (eg, 5-year DRFI rate) is estimated using Kaplan-Meier method. (NCT00310180)
Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years

Intervention	percentage of participants (Number)
Arm A	99.3
Arm B	98.0
Arm C	98.2
Arm D	93.0

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5-year Disease-free Survival

Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method, and compared between the two randomized arms (arm B vs. arm C) using stratified log rank test and stratified Cox proportional hazard model. (NCT00310180)
Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years

Intervention	percentage of participants (Number)
Arm A	94.0
Arm B	92.8
Arm C	93.1
Arm D	87.6

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5-year Disease-free Survival by Age and Recurrence Score Groups

Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. >25) and age groups (<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method. (NCT00310180)
Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years

,,,

Intervention	percentage of participants (Number)
	RS 0-10 & Age<=50	RS 0-10 & Age 51-65	RS 0-10 & Age 66-75	RS 11-15 & Age <=50	RS 11-15 & Age 51-65	RS 11-15 & Age 66-75	RS 16-20 & Age <=50	RS 16-20 & Age 51-65	RS 16-20 & Age 66-75	RS 21-25 & Age <=50	RS 21-25 & Age 51-65	RS 21-25 & Age 66-75	RS >25 & Age <=50	RS >25 & Age 51-65	RS >25 & Age 66-75
Arm A	95.1	94.7	90.5	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA
Arm B	NA	NA	NA	95.1	95.5	87.1	92.0	94.3	90.1	86.3	91.6	93.8	NA	NA	NA
Arm C	NA	NA	NA	94.3	93.9	91.4	94.7	92.2	90.2	92.1	93.4	90.9	NA	NA	NA
Arm D	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	86.4	87.5	89.8

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5-year Recurrence-free Interval

Recurrence-free interval (RFS) is defined as time from date of randomization or registration to the date of first recurrence of breast cancer (ipsilateral breast tumor recurrence, local/regional recurrence, distant recurrence) or to the date of death with recurrence, if death is the first manifestation of recurrence. The distribution of RFS (eg, 5-year RFS rate) is estimated using Kaplan-Meier method. (NCT00310180)
Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years

Intervention	percentage of participants (Number)
Arm A	98.8
Arm B	96.9
Arm C	97.0
Arm D	91.0

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5-year Overall Survival

Overall survival (OS) is defined as time from date of randomization or registration to date of death from any cause. The distribution of OS (eg, 5-year OS rate) is estimated using Kaplan-Meier method. (NCT00310180)
Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years

Intervention	percentage of participants (Number)
Arm A	98.0
Arm B	98.0
Arm C	98.1
Arm D	95.9

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Percentage of Participant With Therapeutic Maintenance Under Anastrozole

Treatment compliance. results based on 109 patients due to missing values (NCT00323479)
Timeframe: 12 months

Intervention	percentage of participants (Number)
Anastrozole 1 mg	80.7

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Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole

Results are based on 97 patients due to missing values (NCT00323479)
Timeframe: 12 months

Intervention	Ng/mL (Mean)
Anastrozole 1 mg	0.5

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Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole

X ray assessment on hands and wrists based on 99 patients due to missing values (NCT00323479)
Timeframe: 12 months

Intervention	millimeter (Median)
Anastrozole 1 mg	1.77

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Functional Index of Cochin at 12 Months in Patients Under Anastrozole.

Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values. (NCT00323479)
Timeframe: 12 months

Intervention	Units on scale (Mean)
Anastrozole 1 mg	4.32

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Number of Participants With New Events of Arthralgia

(NCT00323479)
Timeframe: 12 months

Intervention	Participants (Number)
Anastrozole 1 mg	37

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Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole

X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values (NCT00323479)
Timeframe: 12 months

Intervention	Units on scale (Mean)
Anastrozole 1 mg	12.66

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Change in Serum Estradiol Levels

The change in serum concentrations of estradiol at baseline and 14 days was measured. (NCT00354640)
Timeframe: Baseline and 14 days

Intervention	pmol/l (Median)
Anastrozole and Simvastatin	-3.0

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Change in Blood Concentrations

The change in blood concentrations of anastrozole at baseline and 14 days was measured. (NCT00354640)
Timeframe: Baseline and 14 days

Intervention	ng/ml (Median)
	Anastrozole concentration	Hydroxyanastrozole concentration
Anastrozole and Simvastatin	4.2	-0.03

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Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)

Number of patients event-free (NCT00357110)
Timeframe: 12 month period following randomisation

Intervention	Participants (Number)
Fulvestrant + Anastrozole	6
Anastrozole	7

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Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first. (NCT00405938)
Timeframe: 18 months

Intervention	months (Median)
Bevacizumab/Anastrozole	21
Bevacizumab/Fulvestrant	9

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Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

The Percentage of Patients Who Experience an Objective Benefit From Treatment (CR+PR). The response categories were assigned using RECIST criteria. Complete Response (CR) = Disappearance of all target lesions ; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions. (NCT00405938)
Timeframe: 18 months

Intervention	Participants (Count of Participants)
Bevacizumab/Anastrozole	18
Bevacizumab/Fulvestrant	11

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Pregnancy Rate

Partner pregnancy rate during study participation (NCT00440180)
Timeframe: 4 months

Intervention	participants partner (Number)
Placebo	0
Anastrozole	1

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Tumor Objective Response by MRI

Determine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD. (NCT00481845)
Timeframe: 1 year

Intervention	Participants (Count of Participants)
	Complete Response- CR	Partial Response- PR	Progressive Disease- PD	Stable Disease-SD
Anastrozole	0	0	0	0
Vandetanib + Anastrozole	0	0	0	1

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Pathologic Complete Response

(NCT00481845)
Timeframe: 1 year

Intervention	Participants (Count of Participants)
Vandetanib + Anastrozole	0
Anastrozole	0

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Time to Treatment Failure

(NCT00537771)
Timeframe: Within 3 years

Intervention	days (Median)
Arimidex Group	1112
TAM Group	454

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Incidence of Abnormal Liver Function

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure. (NCT00537771)
Timeframe: At 48 weeks, 96 weeks, 144 weeks

Intervention	participants (Number)
	48 weeks	96 weeks	144 weeks
Arimidex Group	29	37	44
TAM Group	36	40	43

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Incidence of Fatty Liver Disease

The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases. (NCT00537771)
Timeframe: At 48 weeks, 96 weeks, 144 weeks

Intervention	participants (Number)
	48 weeks	96 weeks	144 weeks
Arimidex Group	9	15	26
TAM Group	53	66	72

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Time to Recurrence (TR) Event

"TR event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.~TR event is defined as the evidence of breast cancer recurrence (local and/or distant recurrence of breast cancer, does not include second primary malignancies or deaths from any cause)." (NCT00543127)
Timeframe: Up to 5 years

Intervention	Participants (Count of Participants)
Fulvestrant + Anastrozole	36
Anastrozole	46

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Overall Survival (OS) Event

"OS event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.~OS event is defined as the death from any cause." (NCT00543127)
Timeframe: Up to 5 years

Intervention	Participants (Count of Participants)
Fulvestrant + Anastrozole	28
Anastrozole	34

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Breast Cancer Specific Survival (BCsS) Events

"BCsS events has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to BCsS in patients treated with anastrozole for 5 years.~BCsS event is defined as the death from breast cancer." (NCT00543127)
Timeframe: Up to 5 years

Intervention	Participants (Count of Participants)
Fulvestrant + Anastrozole	17
Anastrozole	18

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Disease Free Survival (DFS) Events

"Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.~DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause." (NCT00543127)
Timeframe: Up to 5 years

Intervention	Participants (Count of Participants)
Fulvestrant + Anastrozole	49
Anastrozole	62

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The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy

In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml. (NCT00555477)
Timeframe: 12 months

Intervention	participants (Number)
Anastrozole Part 1	8
Anastrozole Part 2	13

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Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples

The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale. (NCT00570323)
Timeframe: baseline (pre) to day 28 (post)

Intervention	log-transformed Ki67% (Mean)
ARM A / Arimidex With Faslodex	-1.3632
ARM B Arimidex Without Faslodex	-1.6237

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Adverse Event

Number of participants that experienced adverse events (grade 3 and above) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Adverse events were assessed every week during first 6 weeks of therapy, every 4 weeks on months 1 to 6, every 12 weeks on months 7 and beyond and at the end of treatment. (NCT00573755)
Timeframe: Time from randomization to end of treatment

Intervention	participants (Number)
	Fatigue	Hemoglobin decreased	Mucositis oral	Muscle weakness	Platelet count decreased	Serum potassium increased	Thrombotic microangiopathy	Serum sodium decreased	Mucositis oral (clin exam)
Placebo Plus Aromatase Inhibitor	0	0	0	0	0	0	0	0	0
Sorafenib Plus Aromatase Inhibitor	1	1	1	1	1	1	1	1	1

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Progression-free Survival

Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization. (NCT00573755)
Timeframe: Time from randomization to disease progression or death (up to 5 years)

Intervention	months (Median)
Sorafenib Plus Aromatase Inhibitor	NA
Placebo Plus Aromatase Inhibitor	NA

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Human Epidermal Growth Factor Receptor 2 (HER2) Status

HER2 status in the ITT population is categorized as Positive or Negative (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Participants (Number)
	Baseline Positive & 24 weeks Negative	Baseline Positive & 24 weeks Positive	Baseline Negative & 24 weeks Negative	Baseline Negative & 24 weeks Positive
Anastrozole 1 mg	0	0	92	2
Tamoxifen 20 mg	0	0	88	2

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Serum Oestrone (E1) Concentrations

Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks. (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Ratio (Mean)
Anastrozole 1 mg	0.028
Tamoxifen 20 mg	0.341

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Serum Oestradiol (E2) Concentrations

Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks. (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Ratio (Mean)
Anastrozole 1 mg	0.041
Tamoxifen 20 mg	0.082

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Histopathological Response Rate (HRR)

Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response) (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Percentage of Participants (Number)
Anastrozole 1 mg	41.8
Tamoxifen 20 mg	27.3

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Functional Assessment of Cancer Therapy-Breast (FACT-B)

"Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.~FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).~Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI." (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Trial Outcome Index (TOI) (Prorated) (Mean)
Anastrozole 1 mg	-4.42
Tamoxifen 20 mg	-2.65

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Endocrine Subscale (ES)

"Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.~Score range: 0-72" (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	ES score (Mean)
Anastrozole 1 mg	-8.85
Tamoxifen 20 mg	-6.27

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Anastrozole Plasma Concentrations (Cmin)

Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations. (NCT00605267)
Timeframe: Assessed at week 12

Intervention	ng/mL (Geometric Mean)
Anastrozole 1 mg	29.7

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Best Overall Response Rate (BORR) (MRI/CT)

"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).~CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: 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." (NCT00605267)
Timeframe: 24 weeks

Intervention	Percentage of Participants (Number)
Anastrozole 1 mg	64.3
Tamoxifen 20 mg	37.4

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Bone Turnover Marker (NTX)

Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	nmolBCE(Bone Collagen Equivalent) /L (Mean)
Anastrozole 1 mg	9.17
Tamoxifen 20 mg	2.59

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Bone Turnover Marker (BAP) EIA Method

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	U/L (Mean)
Anastrozole 1 mg	7.1941
Tamoxifen 20 mg	0.7333

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Bone Turnover Marker (BAP) CLEIA Method

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	ug/L (Mean)
Anastrozole 1 mg	3.96
Tamoxifen 20 mg	-0.75

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Bone Mineral Density (BMD) Lumbar Spine

Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine. (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	PercentageBMD=Patient's BMD/standard BMD (Mean)
Anastrozole 1 mg	-5.8
Tamoxifen 20 mg	-2.9

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Bone Mineral Density (BMD) Cervical Thighbone

Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone. (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	PercentageBMD=Patient'sBMD/standard BMD) (Mean)
Anastrozole 1 mg	-2.5
Tamoxifen 20 mg	-0.5

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Best Overall Response Rate (BORR) (US)

"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: 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." (NCT00605267)
Timeframe: 24 weeks

Intervention	Participants (Number)
Anastrozole 1 mg	58.2
Tamoxifen 20 mg	42.4

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Best Overall Response Rate (BORR) (Calliper)

"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: 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." (NCT00605267)
Timeframe: 24 weeks

Intervention	Percentage of Participants (Number)
Anastrozole 1 mg	70.4
Tamoxifen 20 mg	50.5

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Progesterone Receptor (PgR) Status

PgR status in the ITT population is categorized as Positive or Negative. (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Participants (Number)
	Baseline Positive & 24 weeks Negative	Baseline Positive & 24 weeks Positive	Baseline Negative & 24 weeks Negative	Baseline Negative & 24 weeks Positive
Anastrozole 1 mg	60	29	4	1
Tamoxifen 20 mg	19	59	9	3

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Oestrogen Receptor (ER) Status

ER status in the ITT population is categorized as Positive or Negative (NCT00605267)
Timeframe: Assessed at baseline and after 24 weeks of treatment

Intervention	Participants (Number)
	Baseline Positive & 24 weeks Negative	Baseline Positive & 24 weeks Positive	Baseline Negative & 24 weeks Negative	Baseline Negative & 24 weeks Positive
Anastrozole 1 mg	2	92	0	0
Tamoxifen 20 mg	1	89	0	0

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Expression of Estrogen Receptor (ER-beta)

Mean percentage of cells expressing estrogen receptor (ER-beta) (NCT00612560)
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2

,,,

Intervention	percentage of cells (Mean)
	Biopsy	Surgical resection
Arm A - Flaxseed & Active Anastrazole	67.1	45.7
Arm B - Flaxseed	63.3	56.7
Arm C - Anastrozole	45.0	46.7
Arm D - Placebo	62.0	70

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Human Epidermal Growth Factor Receptor 2 (Her2) Expression

Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2) (NCT00612560)
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2

Intervention	percentage of cells (Mean)
	Biopsy	Surgical resection
Arm A - Flaxseed & Active Anastrazole	15	0
Arm B - Flaxseed	40	17.5
Arm D - Placebo	55	30

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Human Epidermal Growth Factor Receptor 2 (Her2) Expression

Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2) (NCT00612560)
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2

Intervention	percentage of cells (Mean)
	Surgical resection
Arm C - Anastrozole	17.5

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Growth Hormone Serum Levels IGF-1

Mean serum level IGF-1(pg/ml) (NCT00612560)
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2

,,,

Intervention	pg/ml (Mean)
	Biopsy	Surgical resection
Arm A - Flaxseed & Active Anastrazole	887.7	938.1
Arm B - Flaxseed	1044.2	980.5
Arm C - Anastrozole	959.1	819.8
Arm D - Placebo	1008.3	880.1

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Progesterone Receptor (PR) Expression

Mean percentage of cells expressing PR (NCT00612560)
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2

,,,

Intervention	percentage of cells (Mean)
	Biopsy	Surgical resection
Arm A - Flaxseed & Active Anastrazole	4	4.5
Arm B - Flaxseed	3.5	2.4
Arm C - Anastrozole	2	1
Arm D - Placebo	4.7	3.5

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Response Rate

Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions) (NCT00661531)
Timeframe: 6 months

Intervention	Participants (Count of Participants)
Estrace & Anastrozole	2

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Progression Free Survival

Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause (NCT00661531)
Timeframe: 6 months

Intervention	Participants (Count of Participants)
Estrace & Anastrozole	7

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Number of Participants Experiencing Adverse Events (AEs) in National Cancer Institute Common Toxicity Criteria for AE's (NCI-CTCAE) Version 3.0 Criteria for Adverse Events (NCI-CTCAE)

The NCI-CTCAE provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Severity will be graded as mild (grade 1), moderate (grade 2), severe (grade 3), or very severe (life threatening - grade 4). Clinically significant events were defined as serious and other non-serious adverse events related to study drug regardless of causality. A summary of serious and other non-serious adverse events is located in the Reported Adverse Event module. (NCT00728949)
Timeframe: Randomization to End of Study up to 36.5 Months

Intervention	Participants (Count of Participants)
	Participants with any AE	Participants with SAE's	AE of greater than Grade 3	AE with outcome of Death	Study drug-related AE	Study drug-related SAE's	Study drug-related AE of greater than Grade 3	AE leading to discontinuation of any study drug
IMC-A12 (Cixutumumab)	36	11	19	2	31	2	7	1
IMC-A12 (Cixutumumab) + Antiestrogen Therapy	55	16	22	3	48	5	10	6

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Percentage of Participants With Complete Response (CR) and Partial Response (PR) or Stable Disease (SD) Disease Control Rate [DCR])

DCR is defined as percentage of participants with CR, PR, or SD using RECIST v 1.0 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100. (NCT00728949)
Timeframe: Randomization to PD up to 35.1 Months

Intervention	percentage of participants (Number)
IMC-A12 (Cixutumumab) + Antiestrogen Therapy	40.3
IMC-A12 (Cixutumumab)	51.6

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12-Month Survival Rate

The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization. (NCT00728949)
Timeframe: From randomization to until the date of first documented date of death from any cause within 12 months, assessed up to 35.1 months

Intervention	percentage of participants (Number)
IMC-A12 (Cixutumumab) + Antiestrogen Therapy	15
IMC-A12 (Cixutumumab)	7.6

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Progression-Free Survival (PFS)

PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions unequivocal progression of non-target lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS will be estimated following the Kaplan-Meier method. (NCT00728949)
Timeframe: From randomization up to 35.1 Months

Intervention	months (Median)
IMC-A12 (Cixutumumab) + Antiestrogen Therapy	2.0
IMC-A12 (Cixutumumab)	3.1

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Overall Survival (OS)

OS is defined as the interval between date of randomization and the date of death due to any cause. Participants who are alive at the time of study completion will be censored at the time the participants was last known to be alive. (NCT00728949)
Timeframe: From randomization up to 36.5 Months

Intervention	months (Median)
IMC-A12 (Cixutumumab) + Antiestrogen Therapy	20.3
IMC-A12 (Cixutumumab)	NA

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Percentage of Participants With Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])

Best overall response of CR or PR was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of longest diameter (SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100. (NCT00728949)
Timeframe: Randomization to PD up to 35.1 Months

Intervention	percentage of participants (Number)
IMC-A12 (Cixutumumab) + Antiestrogen Therapy	1.6
IMC-A12 (Cixutumumab)	0

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Endothelial Progenitor Cells

Number of CD33 + CD134+ cells as a percentage of all lymphocytes (NCT00729859)
Timeframe: Baseline, Day 28

Intervention	percentage of all lymphocytes (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel + Placebo Pill	0.101	0.081

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Quantitative Insulin Sensitivity Check Index (QUICKI)

QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity. (NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	QUICKI index (Mean)
	Baseline	Day 28	Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	0.36	0.34	0.35
Group 2: Acyline, Testosterone Gel, Placebo Pill	0.35	0.35	0.35
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	0.36	0.38	0.36

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Estradiol Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	pmol/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	95.4	31.9
Group 2: Acyline, Testosterone Gel	117.8	109.0
Group 3: Acyline, Testosterone Gel, Anastrozole Pill	96.3	36.5

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Fasting Lipid Levels

(NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	mmol/L (Mean)
	Total cholesterol Day 0	Total cholesterol Day 28	Total cholesterol Day 56	LDL choesterol Day 0	LDL cholesterol Day 28	LDL cholesterol Day 56	HDL cholesterol Day 0	HDL cholesterol Day 28	HDL cholesterol Day 56	Triglycerides Day 0	Triglycerides Day 28	Triglycerides Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	4.97	5.44	4.95	2.95	3.29	2.87	1.19	1.37	1.19	1.79	1.73	1.89
Group 2: Acyline, Testosterone Gel, Placebo Pill	4.48	4.51	4.14	2.77	2.80	2.49	1.32	1.32	1.32	0.82	0.86	0.80
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	4.56	4.56	4.27	2.67	2.75	2.51	1.40	1.32	1.30	1.08	1.08	1.02

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Fasting Serum Insulin

(NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	picomolar (Mean)
	Baseline	Day 28	Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	54	69	54
Group 2: Acyline, Testosterone Gel, Placebo Pill	65	59	64
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	50	42	50

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Follicle Stimulating Hormone (FSH)

(NCT00729859)
Timeframe: Baseline, 28 days

Intervention	IU/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	4.2	0.42
Group 2: Acyline, Testosterone Gel	2.9	0.39
Group 3: Acyline, Testosterone Gel, Anastrazole Pill	2.5	0.87

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Homeostasis Model of Insulin Resistance (HOMA-IR)

HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity. (NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	HOMA score (Mean)
	Baseline	Day 28	Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	1.8	2.4	2.2
Group 2: Acyline, Testosterone Gel, Placebo Pill	2.0	1.9	1.9
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	1.6	1.4	1.7

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Luteinizing Hormone Concentration (LH)

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	IU/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	4.3	0.31
Group 2: Acyline, Testosterone Gel	4.7	0.69
Group 3: Acyline, Testosterone Gel, Anastrozole	4.4	1.55

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Sex Hormone Binding Globulin (SHBG)

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	nmol/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	34.9	37.5
Group 2: Acyline, Testosterone Gel	23.0	22.1
Group 3: Acyline, Testosterone Gel, Anastrozole Pill	27.6	25.1

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Testosterone Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	nmol/L (Mean)
	Baseline testosterone concentration	Day 28 testosterone concentration
Group 1: Acyline + Placebo Gel, Placebo Pill	15.4	0.8
Group 2: Acyline, Testosterone Gel	16.3	17.8
Group 3: Acyline, Testosterone Gel, Anastrozole	16.5	19.0

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Objective Response Rate (ORR) Determined by Mammography

"Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.~Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.)." (NCT00871858)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Arm A (ANA)	26.1
Arm B (FULV)	27.8

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Objective Response Rate (ORR) Determined by Ultrasound

Intervention	percentage of participants (Number)
Arm A (ANA)	35.1
Arm B (FULV)	52.4

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Percentage of Participants With 5-year Relapse-Free Survival

"Relapse-Free survival (RFS) is measured from the date of randomization to the date of the following events, whichever occurs first according to the DATECAN recommendations for breast cancer:~Invasive ipsilateral breast tumor recurrence/ progression ;~Local invasive recurrence/progression ;~Regional invasive recurrence/progression (N+: regional progression) ;~Appearance/Occurrence of Metastatic recurrence;~Death whatever the cause.~Participants who did not experience events were censored at the date of last follow-up. RFS was estimated using the Kaplan-Meier method. No comparison test was performed between the two arms as this study is non-comparative." (NCT00871858)
Timeframe: 5 years

Intervention	Percentage of participants (Number)
Arm A (ANA)	82.8
Arm B (FULV)	74.7

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Rate of Breast-conserving Surgery

breast-conserving surgery concerns patients who did not undergo mastectomy. (NCT00871858)
Timeframe: 6 months

Intervention	percentage of participants (Number)
Arm A (ANA)	60.7
Arm B (FULV)	50.0

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Objective Response Rate (ORR) Determined by Clinical Palpation

Intervention	percentage of participants (Number)
Arm A (ANA)	58.9
Arm B (FULV)	53.8

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Pathologic Complete Response (PCR) Rate

Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant). (NCT00921115)
Timeframe: 4 months

Intervention	participants (Number)
Arimidex + Faslodex	0

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Number of Subjects That Completed Oral Anastrozole 1mg Daily for Two Weeks in the Interval Between Diagnostic Breast Biopsy and Definitive Breast Surgery

The number of subjects who complete oral anastrozole for the length of the study is analyzed. The subjects receive oral anastrozole 1mg daily for two weeks in the interval between the biopsy and the surgery. (NCT01004744)
Timeframe: Two weeks

Intervention	participants (Number)
Presurgical Oral Anastrozole	10

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Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone

Time from the date of randomization to the date of death (by any cause) (NCT01151215)
Timeframe: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status

Intervention	Months (Median)
AZD8931 40mg + Anastrozole 1mg	6.9
AZD8931 20mg + Anastrozole 1mg	8.3
Placebo + Anastrozole 1mg	7.9

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Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions. (NCT01151215)
Timeframe: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012

Intervention	Months (Median)
AZD8931 40mg + Anastrozole 1mg	13.8
AZD8931 20mg + Anastrozole 1mg	10.9
Placebo + Anastrozole 1mg	14.0

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Duration of Response

Duration of response will be summarized for responders. (NCT01153672)
Timeframe: Up to approximately 5 years

Intervention	weeks (Median)
Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)	25.4

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Overall Survival

Kaplan-Meier survival curves will be used to describe overall survival. Overall survival time will be censored on the last date the patient was known to be alive. (NCT01153672)
Timeframe: Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years

Intervention	months (Median)
Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)	28.8

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Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

(NCT01153672)
Timeframe: Up to approximately 5 years

Intervention	percentage of participants (Number)
Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)	37.5

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Progression-free Survival

Kaplan-Meier survival curves will be used to describe progression-free survival. For progression-free survival, patients without documented disease progression or death will be treated as censored observations on the date of the last tumor assessment. (NCT01153672)
Timeframe: Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years

Intervention	months (Median)
Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)	2.8

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Rate of Clinical Benefit According to RECIST

Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria (NCT01153672)
Timeframe: Up to approximately 5 years

Intervention	percentage of evaluable participants (Number)
Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)	15

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Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Anastrozole Cmax. (NCT01182181)
Timeframe: Blood samples collected over a 72 hour period.

Intervention	ng/mL (Mean)
Anastrazole (Test)	17.1
Arimidex® (Reference)	17.8

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AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Anastrozole AUC0-t. (NCT01182181)
Timeframe: Blood samples collected over a 72 hour period.

Intervention	ng*h/mL (Mean)
Anastrazole (Test)	503
Arimidex® (Reference)	519

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Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Anastrozole Cmax. (NCT01183390)
Timeframe: Blood samples collected over a 72 hour period.

Intervention	ng/mL (Mean)
Anastrazole (Test)	14.1
Arimidex® (Reference)	14.2

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AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Anastrozole AUC0-t. (NCT01183390)
Timeframe: Blood samples collected over a 72 hour period.

Intervention	ng*h/mL (Mean)
Anastrazole (Test)	498
Arimidex® (Reference)	501

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Intratesticular Dihydrotestosterone (DHT) Level

(NCT01215292)
Timeframe: 10 days

Intervention	ng/mL (Median)
Acyline + Testosterone Gel (Tgel)+ Placebo	3.17
Acyline & TGel & Ketoconazole 400 mg	2.08
Acyline & TGel & Ketoconazole 800 mg	1.46
Acyline & TGel & Dutasteride	0.12
Acyline & TGel & Anastrazole	3.63

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Intratesticular Testosterone (IT-T) Level

(NCT01215292)
Timeframe: 10 days

Intervention	ng/mL (Median)
Acyline + Testosterone Gel + Placebo	14
Acyline + Tgel + Ketoconazole 400mg	3.7
Acyline + Tgel + Ketoconazole 800mg	1.7
Acyline & TGel & Dutasteride 2.5mg	18.4
Acyline & TGel & Anastrazole 1mg	24.0

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Intratesticular Androstenedione (ADD) Level

(NCT01215292)
Timeframe: 10 days

Intervention	ng/mL (Median)
Acyline + Testosterone Gel (Tgel)+ Placebo	.87
Acyline + Tgel + Ketoconazole 400mg	0.5
Acyline + Tgel + Ketoconazole 800mg	0.12
Acyline & TGel & Dutasteride 2.5mg	1.7
Acyline & TGel & Anastrazole 1mg	3.6

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Phase II - Cohort B: Number of Participants With Pathologic Complete Response (pCR)

A pathologic complete response will be defined as the absence of viable tumor cells in the resected specimen, as determined by standard histologic examination. All specimens will be reviewed by a central pathologist to determine pathologic response. (NCT01216176)
Timeframe: At completion of 4-6 cycles of therapy or after disease progression

Intervention	Participants (Count of Participants)
Phase 2 - Cohort B [Anastrozole + AZD0530]	0
Phase 2 - Cohort B [Anastrozole + Placebo]	0

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Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI

MRI will be used to compare tumor size at baseline and at 10 weeks. MRI will also be used to compare tumor size at baseline and after completion of 6 months of study medication or disease progression. (NCT01216176)
Timeframe: Baseline to 10 weeks;and baseline to 6 months

Intervention	percentage of tumor volume change (Mean)
	MRI RECIST % change 10 weeks	MRI tumor volume % change 10 weeks	MRI RECIST % change 6 months	MRI tumor volume % change 6 months
Phase 2 - Cohort B [Anastrozole + AZD0530]	-26.9	-46.4	-44.6	-70.7
Phase 2 - Cohort B [Anastrozole + Placebo]	-15.9	-35.0	-22.5	-43.2

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Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD)

Based on physician measurement of tumor size and by MRI measurements of tumor volume using RECIST criteria (NCT01216176)
Timeframe: At the end of neoadjuvant therapy

Intervention	Participants (Count of Participants)
	Complete Response	Partial Response	Stable Disease	Disease Progression
Phase 2 - Cohort B [Anastrozole + AZD0530]	0	16	0	7
Phase 2 - Cohort B [Anastrozole + Placebo]	0	17	0	2

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Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response

Clinical response is defined as percentage change in tumor size calculated from bi-dimensional clinical tumor measurement at diagnosis and on completion of neoadjuvant treatment. The mean reduction in tumor size ( +/-SD) will be derived form the change in largest tumor dimension ( RECIST) and by calculated tumor volume (NCT01216176)
Timeframe: Baseline, cycle 6

Intervention	percentage of tumor volume change (Mean)
	Max clinical diameter % change	Clinical tumor volume% change
Phase 2 - Cohort B [Anastrozole + AZD0530]	-61.5	-87.9
Phase 2 - Cohort B [Anastrozole + Placebo]	-62.3	-90.7

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Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole

To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range. (NCT01216176)
Timeframe: Cycle 1: Days 1 - 28

Intervention	mg/day oral dose (Number)
	anastrozole	saracatinib
Phase 1 - Cohort A	1	175

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Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole

Summarized as mean plasma concentrations (ng/ml) of each drug (AZD0530 (saracatinib) and Anastrozole) after exposure to dual therapy. (NCT01216176)
Timeframe: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 8 days, 15 days, 22 days after first dose of AZD0530

Intervention	ng/ml (Mean)
	AZD0530 - Cycle 1: 0 hrs	AZD0530 - Cycle 1: 6 hrs	AZD0530 - Cycle 1: 12 hrs	AZD0530 - Cycle 1: 24 hrs	AZD0530 - Cycle 1: 48 hrs	AZD0530 - Cycle 1: 72 hrs	AZD0530 - Day 8	AZD0530 - Day 15	AZD0530 - Day 22	Anastrozole - Day 1: 0 hrs	Anastrozole - Day 1: 6 hrs	Anastrozole - Day 1: 12 hrs	Anastrozole - (24 hrs)	Anastrozole - (48 hrs)	Anastrozole - (72 hrs)	Anastrozole - Day 8	Anastrozole - Day 15	Anastrozole - Day 22
Phase 1 - Cohort A	0	127.47	79.1	46.17	91.33	125.49	232.23	213.52	271.97	26.35	38.2	33.45	29.33	32.81	34.08	51.00	46.75	47.33

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Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole)

Summarized as the geometric means and standard deviations for the corresponding for peak plasma concentration of each study drug ( AZD0530 (saracatinib) and anastrozole) after exposure (NCT01216176)
Timeframe: 0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 7 days, 14 days, 21 days after first dose of AZD0530

Intervention	ng/ml (Geometric Mean)
	AZD0530 (saracatinib) ng/ml	anastrozole ng/ml
Phase 1 - Cohort A	271.97	47.33

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Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole

Blood draws at protocol-specified timepoints to determine mean blood levels of drug for each of AZD0530 and Anastrozole. (NCT01216176)
Timeframe: Day 28, 56, 84

Intervention	ng/ml (Mean)
	Anastrozole - Day 28	Anastrozole - Day 56	Anastrozole - Day 84	AZD0530 - Day 28	AZD0530 - Day 56	AZD0530 - Day 84
Phase 2 - Cohort B [Anastrozole + AZD0530]	52.7	49.9	48.3	264.6	286.4	258.6

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Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole

Blood draws at protocol-specified timepoints to determine mean blood levels of drug for each of AZD0530 and Anastrozole. (NCT01216176)
Timeframe: Day 28, 56, 84

Intervention	ng/ml (Mean)
	Anastrozole - Day 28	Anastrozole - Day 56	Anastrozole - Day 84
Phase 2 - Cohort B [Anastrozole + Placebo]	37.4	37.6	39.5

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Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo

Cinically significant AEs defined as clinically significant changes in the patient's symptoms, physical examination and clinical laboratory results are reported as toxicity for AZD0530 (saracatinib) given with anastrozole and for anastrozole given with placebo (NCT01216176)
Timeframe: From day 1 of treatment until a maximum of 6 months of treatment

Intervention	Participants (Count of Participants)
	Anemia	Neutropenia	Thrombocytopenia	Fatigue	Rash	Alopecia	Hot Flashes	Anorexia	Diarrhea	Alanine aminotransferase increased	Alkaline phosphatase increased	Aspartate aminotransferase increased	Creatinine increased	Hyperbilirubinemia	Flu-like syndrome	Upper Respiratory Infection	Urinary Tract Infection
Phase 2 - Cohort B [Anastrozole + AZD0530]	7	4	3	10	24	17	18	8	23	19	11	20	3	3	9	14	13
Phase 2 - Cohort B [Anastrozole + Placebo]	1	1	0	3	3	2	7	1	6	3	0	1	1	0	1	2	1

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Number of Participants With Adverse Events

To address the safety of the regimen, a maximum width 90% confidence interval for any grade 3 or higher toxicity will be approximately 30%. For 5 patients in this study, if the true unknown probability of a rare toxicity is 10%, the probability of observing 1 or more toxicities is 97%, and if the true toxicity rate is 5% then the probability of observing one or more rare toxicities is 83%. (NCT01234532)
Timeframe: Participants were followed during the study and for 30 days post treatment, up to 59 days

Intervention	Participants (Count of Participants)
Entinostat & Anastrozole Neoadjuvant	5

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Change in Proliferative Index (Ki67) (Phase II)

The 95% confidence intervals will be constructed for the observed proportions. Exploratory data analysis and appropriate graphs will be used to decide whether data transformation (e.g. log or square-root) is necessary to assure an approximate normality. All descriptive statistics will be reported for ER and Ki67 expression. The general linear model approach and/or its non parametric alternative, the Wilcoxon test, will be used to assess whether there is any evidence of changes due to treatment. (NCT01234532)
Timeframe: Baseline to the time of surgery, within 6 days after the last dose of entinostat, up to 35 days

Intervention	percentage of Ki 67 expression (Number)
Entinostat & Anastrozole Neoadjuvant	NA

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Change in HER2

Will be treated as continuous variables. Multivariate analysis of variance may also be used to compare correlated biomarkers' expression. Correlation between biomarkers will be estimated and tested. The repeated measures model approach will be also used. Categorical outcome data (e.g., number of proteins expressed) will be recorded, proportions will be estimated and compared using the Fisher's exact test. (NCT01234532)
Timeframe: Baseline before study treatment and at the time of surgery, up to 30 days

Intervention	score on a scale (Number)
Entinostat & Anastrozole Neoadjuvant	NA

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Change in Estrogen-receptor (ER) Expression (Phase II)

The 95% confidence intervals will be constructed for the observed proportions. Exploratory data analysis and appropriate graphs will be used to decide whether data transformation (e.g. log or square-root) is necessary to assure an approximate normality. All descriptive statistics will be reported for ER and Ki67 expression. The general linear model approach and/or its non parametric alternative, the Wilcoxon test, will be used to assess whether there is any evidence of changes due to treatment. (NCT01234532)
Timeframe: Baseline before the study treatment and at the time of surgery, up to 30 days

Intervention	percentage of (ER) expression (Number)
Entinostat & Anastrozole Neoadjuvant	NA

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Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot)

Since the study was terminated early there was insufficient data for analysis and to recommend a phase II dose of entinostat in combination with anastrozole (NCT01234532)
Timeframe: Duration of the study is 29 days followed by 30 days end of study assessment visit, up to 59 days

Intervention	mg (Mean)
Entinostat & Anastrozole Neoadjuvant	NA

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Change in Body Mass Index

(NCT01248416)
Timeframe: 0 to 24 months

Intervention	kg/m^2 (Mean)
Aromatase Inhibitor	2.5
Growth Hormone	1.7
Aromatase Inhibitor and Growth Hormone	2.5

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Change in Bone Density z Score Adjusted for Height

(NCT01248416)
Timeframe: 0 to 24 months

Intervention	z-score (Least Squares Mean)
Aromatase Inhibitor	-1.061
Growth Hormone	-0.586
Aromatase Inhibitor and Growth Hormone	-0.605

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Change in Estradiol

Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole. (NCT01248416)
Timeframe: 0 to 24 months

Intervention	pg/mL (Mean)
Anastrozole	8
Letrozole	4

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Change in Estrone

(NCT01248416)
Timeframe: 0 to 24 months

Intervention	pg/mL (Mean)
Aromatase Inhibitor	0.0
Growth Hormone	6.1
Aromatase Inhibitor and Growth Hormone	-0.9

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Change in Height

Differences in height gains (NCT01248416)
Timeframe: 0 to 24 months

Intervention	Centimeters (Mean)
Aromatase Inhibitor	14
Growth Hormone	17.1
Aromatase Inhibitor and Growth Hormone	18.9

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Change in Testosterone

(NCT01248416)
Timeframe: 0 to 24 months

Intervention	ng/dL (Mean)
Aromatase Inhibitor	737
Growth Hormone	372
Aromatase Inhibitor and Growth Hormone	668

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Change in Predicted Height

Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years) (NCT01248416)
Timeframe: 0 to 24 months

Intervention	centimeters (Least Squares Mean)
Aromatase Inhibitor	0.5
Growth Hormone	4.9
Aromatase Inhibitor and Growth Hormone	7.4

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Change in Lean Body Mass

(NCT01248416)
Timeframe: 0 to 24 months

Intervention	kg (Mean)
Aromatase Inhibitor	42.2
Growth Hormone	42.0
Aromatase Inhibitor and Growth Hormone	46.5

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Change in IGF-I Concentrations

(NCT01248416)
Timeframe: 0 to 24 months

Intervention	ng/mL (Mean)
Aromatase Inhibitor	158
Growth Hormone	280
Aromatase Inhibitor and Growth Hormone	303

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Distant Relapse-Free Survival (DRFS)

"Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence or death due to any cause. Participants last known to be alive who have not experienced distant recurrence are censored at their last contact date. This outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Kaplan-Meier estimates were calculated for the 5-year DRFS rate.~Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status. The NCI and the data and safety monitoring committee recommended early reporting of the data. Due to subsequent data collection and data cleaning, the population of eligible and evaluable participants differs slightly between the reporting of this outcome and the Participant Flow section." (NCT01272037)
Timeframe: 5 years after randomization

Intervention	percentage of participants (Number)
	Premenopausal participants	Postmenopausal participants
Chemo and Endocrine Therapy	96.1	94.4
Endocrine Therapy Alone	92.8	94.4

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Invasive Disease-Free Survival (IDFS)

"From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate.~Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section." (NCT01272037)
Timeframe: 5 years after randomization

Intervention	percentage of participants (Number)
	Premenopausal	Postmenopausal
Chemo and Endocrine Therapy	93.9	91.3
Endocrine Therapy Alone	89.0	91.9

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Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization. (NCT01272037)
Timeframe: Duration of treatment and follow-up until death or 3 years after randomization

Intervention	Participants (Number)
	Abdominal infection	Abdominal pain	Acute kidney injury	Alanine aminotransferase increased	Alkaline phosphatase increased	Allergic reaction	Anemia	Anorexia	Anxiety	Arthralgia	Aspartate aminotransferase increased	Atrial fibrillation	Back pain	Blood and lymphatic system disorders - Other	Bone marrow hypocellular	Bone pain	Breast infection	Bronchial infection	CD4 lymphocytes decreased	Cardiac arrest	Cataract	Catheter related infection	Chest pain - cardiac	Chest wall pain	Colitis	Constipation	Death NOS	Dehydration	Depression	Dermatitis radiation	Device related infection	Diarrhea	Dizziness	Dry mouth	Dry skin	Dyspareunia	Dyspepsia	Dyspnea	Ear pain	Edema limbs	Ejection fraction decreased	Erythema multiforme	Erythroderma	Esophagitis	Fatigue	Febrile neutropenia	Fever	Flank pain	Flu like symptoms	GGT increased	Gastric hemorrhage	Gastric ulcer	Gastrointestinal disorders - Other, specify	Gastrointestinal pain	General disorders and admin site conditions - Other	Generalized muscle weakness	Headache	Heart failure	Hematuria	Hemorrhoids	Hot flashes	Hyperglycemia	Hyperhidrosis	Hypertension	Hypokalemia	Hyponatremia	Hypotension	INR increased	Infections and infestations - Other, specify	Injection site reaction	Insomnia	Irregular menstruation	Joint range of motion decreased	Kidney infection	Left ventricular systolic dysfunction	Leukemia secondary to oncology chemotherapy	Leukocytosis	Lipase increased	Localized edema	Lung infection	Lymphedema	Lymphocyte count decreased	Menorrhagia	Mucositis oral	Muscle weakness lower limb	Musculoskeletal and connective tiss disorder - Other	Myalgia	Myelitis	Myocardial infarction	Nausea	Neck pain	Neoplasms benign, malignant and unspecified - Other	Nervous system disorders - Other, specify	Neutrophil count decreased	Osteoporosis	Pain	Pain in extremity	Palmar-plantar erythrodysesthesia syndrome	Paresthesia	Peripheral ischemia	Peripheral motor neuropathy	Peripheral sensory neuropathy	Platelet count decreased	Pleuritic pain	Pneumonitis	Premature menopause	Pruritus	Radiation recall reaction (dermatologic)	Rash acneiform	Rash maculo-papular	Renal and urinary disorders - Other, specify	Reproductive system and breast disorders - Other	Sepsis	Sinus tachycardia	Skin and subcutaneous tissue disorders - Other	Skin infection	Skin ulceration	Stroke	Suicidal ideation	Supraventricular tachycardia	Surgical and medical procedures - Other, specify	Syncope	Thromboembolic event	Tinnitus	Typhlitis	Upper gastrointestinal hemorrhage	Upper respiratory infection	Urinary tract infection	Urticaria	Uterine hemorrhage	Vaginal dryness	Vaginal hemorrhage	Vascular access complication	Vomiting	Watering eyes	Weight gain	Weight loss	White blood cell decreased	Wound dehiscence
Chemo and Endocrine Therapy	1	7	1	4	1	6	20	2	2	48	0	3	1	4	1	15	2	1	2	1	0	3	1	0	5	4	0	11	3	4	4	31	3	1	1	1	1	2	2	1	1	1	1	3	48	83	3	1	1	2	1	1	1	1	2	4	7	1	1	1	12	16	1	8	5	2	3	0	3	1	9	3	1	1	1	2	4	1	1	6	1	20	0	23	1	1	24	1	2	21	2	3	1	150	1	2	2	7	2	0	4	21	3	1	8	1	5	2	1	8	1	1	5	1	6	9	1	2	1	1	2	3	9	1	1	1	1	4	4	0	0	1	1	19	4	4	2	65	1
Endocrine Therapy Alone	0	0	0	2	0	1	0	0	1	35	1	1	1	0	0	5	0	0	1	0	1	0	0	1	0	0	1	0	6	4	0	3	1	0	0	1	0	0	0	0	0	0	1	0	9	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	14	1	0	6	0	0	1	1	0	0	4	1	0	0	0	0	0	0	1	0	1	0	1	0	0	0	8	0	0	0	0	0	0	1	0	0	1	0	0	1	0	2	0	0	0	0	1	0	0	2	0	0	0	0	5	0	0	3	0	1	4	0	4	0	0	0	0	0	0	1	4	1	0	0	0	1	0	0	0

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Preoperative Endocrine Prognostic Index Score (PEPI Score)

To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome). (NCT01368263)
Timeframe: At time of definitive surgery

Intervention	participants (Number)
	PEPI Score 1	PEPI Score 4	PEPI Score 7	PEPI Score 8
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	1	1	1	1

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PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less

(NCT01368263)
Timeframe: 16 weeks

Intervention	percentage of participants (Number)
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	0

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Plasma Estradiol (E2) Level

(NCT01545336)
Timeframe: Baseline, 3 months

Intervention	% change from baseline (Median)
Anastrozole	-40
Placebo	-4

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Six Minute Walk Distance

(NCT01545336)
Timeframe: Baseline, 3 months

Intervention	% change from baseline (Median)
Anastrozole	8
Placebo	-2

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Tricuspid Annular Plane Systolic Excursion (TAPSE)

(NCT01545336)
Timeframe: Baseline, 3 months

Intervention	% change from baseline (Median)
Anastrozole	7
Placebo	10

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Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT01597193)
Timeframe: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)

Intervention	percentage of participants (Number)
Dose Escalation: Enzalutamide 80 mg	28.6
Dose Escalation: Enzalutamide 160 mg	12.5
Dose Expansion: Enzalutamide 160 mg	14.3
Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg	5.0
Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg	31.3
Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg	13.0
Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg	18.2

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Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing

Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50

Intervention	ratio (Mean)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	9.39	68.0	77.8
Dose Escalation: Enzalutamide 80 mg	17.9	47.6	157

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Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing

Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50

Intervention	milligram*hour per milliliter (Mean)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	325	120	317
Dose Escalation: Enzalutamide 80 mg	207	33.0	140

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Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose

Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1

Intervention	micrograms*hour per milliliter (Mean)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	41.6	1.20	2.76
Dose Escalation: Enzalutamide 80 mg	17.3	0.632	1.13

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Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing

Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50

Intervention	micrograms per milliliter (Mean)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	15.3	6.24	14.1
Dose Escalation: Enzalutamide 80 mg	11.6	1.77	6.42

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Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose

Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1

Intervention	micrograms per milliliter (Mean)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	4.01	0.0707	0.184
Dose Escalation: Enzalutamide 80 mg	1.90	0.0375	0.0879

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Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing

Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50

Intervention	ratio (Mean)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	1.14	1.42	1.00
Dose Escalation: Enzalutamide 80 mg	1.39	1.32	0.999

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Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing

Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50

Intervention	hours (Median)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	1.00	2.29	0.58
Dose Escalation: Enzalutamide 80 mg	0.500	5.70	24.0

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Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing

Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1

Intervention	hours (Median)
	Enzalutamide	M1	M2
Dose Escalation: Enzalutamide 160 mg	1.00	23.1	23.7
Dose Escalation: Enzalutamide 80 mg	0.500	24.1	23.9

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Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs

Absolute systolic blood pressure (SBP) greater than (>) 180 millimeter of mercury (mm Hg) and an increase of >40 mm Hg from baseline; absolute SBP less than (<) 90 mm Hg and an decrease of >30 mm Hg from baseline. Absolute diastolic blood pressure (DBP) >105 mm Hg and an increase of >30 mm Hg from baseline; absolute DBP <50 mm Hg and an increase of >20 mm Hg from baseline. Absolute heart rate >120 beats per minute (bpm) and an increase of >30 bpm from baseline; absolute heart rate <50 bpm and decrease of >20 bpm from baseline. Participants with any of these abnormalities were reported for this outcome in each arm. (NCT01597193)
Timeframe: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)

,,,,,,

Intervention	percentage of participants (Number)
	Blood pressure	Heart rate
Dose Escalation: Enzalutamide 160 mg	0	2
Dose Escalation: Enzalutamide 80 mg	1	0
Dose Expansion: Enzalutamide 160 mg	1	1
Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg	0	0
Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg	1	0
Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg	2	0
Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg	1	0

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Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1

Intervention	micrograms*hour per milliliter (Mean)
Dose Escalation: Enzalutamide 80 mg	208
Dose Escalation: Enzalutamide 160 mg	478

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Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing

Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1

Intervention	liter per hour (Mean)
Dose Escalation: Enzalutamide 80 mg	0.426
Dose Escalation: Enzalutamide 160 mg	0.382

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Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1

Intervention	liter (Mean)
Dose Escalation: Enzalutamide 80 mg	151
Dose Escalation: Enzalutamide 160 mg	94.5

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Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing

Intervention	liter per hour (Mean)
Dose Escalation: Enzalutamide 80 mg	0.390
Dose Escalation: Enzalutamide 160 mg	0.507

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Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing

(NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1

Intervention	micrograms*hour per milliliter (Mean)
Dose Escalation: Enzalutamide 80 mg	43.0
Dose Escalation: Enzalutamide 160 mg	107

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Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)

DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug. (NCT01597193)
Timeframe: Baseline up to Day 35

Intervention	percentage of participants (Number)
Dose Escalation: Enzalutamide 80 mg	16.7
Dose Escalation: Enzalutamide 160 mg	0.0

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Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing

Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration. (NCT01597193)
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1

Intervention	hours (Mean)
Dose Escalation: Enzalutamide 80 mg	280
Dose Escalation: Enzalutamide 160 mg	198

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Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide

(NCT01597193)
Timeframe: pre-dose on Day 57

Intervention	micrograms per milliliter (Mean)
Dose Expansion: Enzalutamide 160 mg	13.40
Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg	14.33
Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg	13.52
Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg	12.41
Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg	11.62

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Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. (NCT01597193)
Timeframe: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)

Intervention	percentage of participants (Number)
Dose Escalation: Enzalutamide 80 mg	0.0
Dose Escalation: Enzalutamide 160 mg	0.0
Dose Expansion: Enzalutamide 160 mg	7.1
Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg	5.0
Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg	12.5
Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg	13.0
Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg	0.0

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Percentage of Participants Who Require Dose Reductions Due to Adverse Events

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. (NCT01597193)
Timeframe: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)

Intervention	percentage of participants (Number)
Dose Escalation: Enzalutamide 80 mg	0.0
Dose Escalation: Enzalutamide 160 mg	0.0
Dose Expansion: Enzalutamide 160 mg	0.0
Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg	20.0
Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg	12.5
Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg	8.7
Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg	18.2

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Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event. (NCT01597193)
Timeframe: Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)

Intervention	percentage of participants (Number)
Dose Escalation: Enzalutamide 80 mg	57.1
Dose Escalation: Enzalutamide 160 mg	12.5
Dose Expansion: Enzalutamide 160 mg	21.4
Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg	30.0
Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg	37.5
Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg	39.1
Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg	36.4

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Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL)

The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprises the following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of randomisation to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported. (NCT01602380)
Timeframe: Quality of life questionnaires completed at baseline and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).

Intervention	months (Median)
	Time to TOI deterioration	Time to FACT-B total score deterioration
Anastrozole 1 mg	11.1	11.1
Fulvestrant 500 mg	13.8	13.8

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Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment

ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response [PR] or complete response [CR]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).

Intervention	Percentage of participants (Number)
Fulvestrant 500 mg	46.1
Anastrozole 1 mg	44.9

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Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment

EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65). (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).

Intervention	Days (Number)
Fulvestrant 500 mg	346.84
Anastrozole 1 mg	227.58

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Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment

EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65). (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).

Intervention	Days (Number)
Fulvestrant 500 mg	667.94
Anastrozole 1 mg	532.04

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Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment

DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off)..

Intervention	Months (Median)
Fulvestrant 500 mg	20.0
Anastrozole 1 mg	13.2

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Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment

DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression. (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).

Intervention	Months (Median)
Fulvestrant 500 mg	22.1
Anastrozole 1 mg	19.1

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Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole

PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique. (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months for the primary analysis data cut-off).

Intervention	Months (Median)
Fulvestrant 500 mg	16.6
Anastrozole 1 mg	13.8

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Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events

OS was defined as the time from randomisation until death by any cause. Two timepoints were planned for OS analysis: an interim OS analysis at the time of the data cut-off for PFS analysis and a final OS analysis when 75% of the deaths have occurred. The current OS data correspond to that of the interim analysis only and the outcome measure is reported as percentage of patients with events. (NCT01602380)
Timeframe: Baseline up to data cut-off for PFS analysis (up to approximately 38 months). Following disease progression, patients were to be contacted at 12 weekly intervals to to determine survival status.

Intervention	Percentage of participants (Number)
Fulvestrant 500 mg	29.1
Anastrozole 1 mg	32.3

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Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment

CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks. (NCT01602380)
Timeframe: Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).

Intervention	Percentage of participants (Number)
Fulvestrant 500 mg	78.3
Anastrozole 1 mg	74.1

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Overall Survival (OS)

Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The results were presented as 5-year OS estimate. (NCT01674140)
Timeframe: 5 years after last accrual

Intervention	percentage of participants (Number)
Placebo	85.8
Everolimus	88.1

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Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.

Toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported. (NCT01674140)
Timeframe: Every 6 weeks while on protocol therapy. Adverse events (AEs) that occurred during follow up after protocol treatment were reported as late AEs, for every 6 months for the first 2 years and then yearly until 10 years after registration.

Intervention	Participants (Number)
	Abdominal pain	Alanine aminotransferase increased	Allergic reaction	Anemia	Anxiety	Appendicitis	Appendicitis perforated	Arthralgia	Ascites	Aspartate aminotransferase increased	Back pain	Bone pain	Breast infection	Cardiac arrest	Cholecystitis	Cholesterol high	Colitis	Cough	Dehydration	Depression	Diarrhea	Dizziness	Dyspnea	Edema face	Edema limbs	Eye disorders - Other, specify	Eye infection	Fatigue	Fever	Gallbladder infection	Gallbladder perforation	Gastrointestinal disorders - Other, specify	General disorders and admin site conditions - Other	Generalized muscle weakness	Headache	Heart failure	Hip fracture	Hot flashes	Hyperglycemia	Hyperhidrosis	Hyperkalemia	Hypertension	Hypertriglyceridemia	Hypokalemia	Hyponatremia	Hypophosphatemia	Hypoxia	Immune system disorders - Other, specify	Infections and infestations - Other, specify	Infusion related reaction	Insomnia	Investigations - Other, specify	Irregular menstruation	Joint infection	Kidney infection	Left ventricular systolic dysfunction	Lipase increased	Lung infection	Lymphedema	Lymphocyte count decreased	Menorrhagia	Mucositis oral	Muscle weakness lower limb	Muscle weakness upper limb	Musculoskeletal and connective tiss disorder - Other	Myalgia	Nasal congestion	Nausea	Neck pain	Nervous system disorders - Other, specify	Neuralgia	Neutrophil count decreased	Obesity	Otitis media	Pain	Pain in extremity	Papulopustular rash	Paroxysmal atrial tachycardia	Periorbital edema	Peripheral sensory neuropathy	Platelet count decreased	Pleural effusion	Pneumonitis	Portal vein thrombosis	Postoperative hemorrhage	Productive cough	Pruritus	Psychiatric disorders - Other, specify	Pulmonary edema	Radiation recall reaction (dermatologic)	Rash acneiform	Rash maculo-papular	Rash pustular	Respiratory failure	Sepsis	Seroma	Skin and subcutaneous tissue disorders - Other	Skin infection	Skin ulceration	Soft tissue infection	Sore throat	Suicidal ideation	Suicide attempt	Thromboembolic event	Tooth infection	Upper respiratory infection	Urinary tract infection	Vascular access complication	Vomiting	Weight gain	Weight loss	White blood cell decreased	Wound complication	Wound dehiscence	Wound infection
Everolimus	7	4	2	10	0	1	2	5	1	6	0	1	6	0	1	9	1	2	3	2	13	2	7	1	1	1	1	23	1	1	1	2	1	1	4	4	1	0	33	2	1	15	35	5	2	1	2	1	5	1	3	1	1	1	2	2	0	6	1	36	0	60	1	0	1	2	1	2	1	0	1	22	0	1	0	0	1	0	2	2	4	2	7	1	1	1	2	0	1	2	1	4	2	0	7	1	3	8	2	2	1	1	1	5	1	1	2	1	1	0	2	20	5	4	6
Placebo	1	1	0	0	1	2	0	1	0	1	1	0	1	1	0	0	1	0	0	0	3	0	2	0	0	0	0	6	0	0	0	0	0	0	1	0	0	2	1	0	0	6	4	0	0	0	0	0	4	0	0	0	1	0	0	0	1	2	0	5	1	2	0	1	0	0	0	0	1	1	0	3	1	0	1	1	0	1	0	1	1	0	1	0	0	0	1	1	0	0	0	0	0	1	0	0	0	3	0	0	0	0	0	3	0	0	1	0	1	2	0	2	0	1	0

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Distant Recurrence-Free Survival (DRFS)

Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. The results were presented as 5-year DRFS estimate. (NCT01674140)
Timeframe: 5 years after last accrual

Intervention	percentage of participants (Number)
Placebo	75.7
Everolimus	76.9

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Invasive Disease-Free Survival (IDFS)

Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. The results were presented as 5-year IDFS estimate. (NCT01674140)
Timeframe: Up to 5 years post registration

Intervention	percentage of participants (Number)
Placebo	74.4
Everolimus	74.9

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Overall Survival

Overall survival is assessed relative to the start of the study therapy to the date of death, from any cause. (NCT01720602)
Timeframe: From the time of start of study therapy to date of documented death

Intervention	months (Median)
Treatment (Vorinostat, AI Therapy)	19

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Duration of Response

Duration of response will be summarized for responders. (NCT01720602)
Timeframe: Up to 5 years

Intervention	weeks (Median)
Treatment (Vorinostat, AI Therapy)	29.6

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Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST

"A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)." (NCT01720602)
Timeframe: 8 weeks

Intervention	percentage of patients (Number)
Treatment (Vorinostat, AI Therapy)	60

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Response Rate According to RECIST

"A 90% score (Wilson) confidence interval will be computed for the response rate.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)." (NCT01720602)
Timeframe: 8 weeks

Intervention	percentage of patients (Number)
Treatment (Vorinostat, AI Therapy)	60

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Progression-free Survival (PFS)

Progression-free survival is assessed relative to the start of the study therapy. Progression can be determined by RECIST 1.1, elevated tumor markers, worsening clinical symptoms or new lesions identified by FDG-PET or bone scan. (NCT01720602)
Timeframe: From the time of start of study therapy to documented progression - up to 5 years

Intervention	months (Median)
Treatment (Vorinostat, AI Therapy)	2

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Number of Participants With Complete Cell Cycle Arrest

Compare rate of complete cell cycle arrest (defined as Ki67 ≤ 2.7%) arrest between C1D1 and C1D15 (NCT01723774)
Timeframe: Cycle 1 day 1 and cycle 1 day 15 (2 weeks)

Intervention	Participants (Count of Participants)
	Cycle 1 Day 1 complete cell cycle arrest	Cycle 1 Day 15 complete cell cycle arrest
Arm 1: PIK3CA Wild Type Cohort	8	23
Arm 2: PIK3CA Mutant Type Cohort	4	16
Arm 3: Endocrine Resistant Cohort	0	19

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Number of Participants With Pathologic Complete Response (pCR)

-A pathologic complete response is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes. (NCT01723774)
Timeframe: At the time of surgery (estimated to be 5 months)

Intervention	Participants (Count of Participants)
Arm 1: PIK3CA Wild Type Cohort	0
Arm 2: PIK3CA Mutant Type Cohort	0
Arm 3: Endocrine Resistant Cohort	0

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Change in Ki67 Level of Tumor Specimens

To assess Ki67 level on serially collected tumor specimens (NCT01723774)
Timeframe: Cycle 1 day 15 and at time of surgery (approximately 2-4 weeks post completion of cycle 4 - each cycle is 28 days)

Intervention	percentage of Ki67 in tumor sample (Mean)
	Cycle 1 Day 15	At time of surgery
Arm 1: PIK3CA Wild Type Cohort	11.70	23.00
Arm 2: PIK3CA Mutant Type Cohort	0.51	8.75
Arm 3: Endocrine Resistant Cohort	0.97	2.84

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Change in Ki67 Level of Tumor Specimens

To assess Ki67 level on serially collected tumor specimens (NCT01723774)
Timeframe: Pre-treatment and cycle 1 day 15

Intervention	percentage of Ki67 in tumor sample (Mean)
	Pre-treatment	Cycle 1 Day 15
Arm 1: PIK3CA Wild Type Cohort	29.75	8.18
Arm 2: PIK3CA Mutant Type Cohort	19.76	0.51
Arm 3: Endocrine Resistant Cohort	33.52	15.27

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Radiologic Response Rate

"The radiological response rate is the number of patients whose disease meets with WHO criteria for complete or partial response at the evaluation prior to surgery divided by the total number of eligible patients who began combination neo-adjuvant therapy.~Complete Response (CR) is defined as the disappearance of all known disease based on a comparison between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy (that is, at the end of cycle 4 neo-adjuvant combination therapy). In addition there is no appearance of new lesions.~Partial Response (PR) is defined as a 50% or greater decrease in the product of the bidimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy (that is, at the end of cycle 4 neo-adjuvant combination therapy). In addition there can be no appearance of new lesions or progression of any lesion." (NCT01723774)
Timeframe: At the end of cycle 4 prior to surgery (estimated to be 16 weeks)

Intervention	Participants (Count of Participants)
Arm 1: PIK3CA Wild Type Cohort	7
Arm 2: PIK3CA Mutant Type Cohort	3
Arm 3: Endocrine Resistant Cohort	6

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Clinical Response Rate

"The clinical response rate is the number of patients whose disease meets the WHO criteria of complete or partial response prior to surgery divided by the total number of eligible patients who began combination neoadjuvant treatment.~Complete Response (CR) is defined as the disappearance of all known disease based on a comparison between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy (that is, at the end of cycle 4 neo-adjuvant combination therapy). In addition there is no appearance of new lesions.~Partial Response (PR) is defined as a 50% or greater decrease in the product of the bidimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy (that is, at the end of cycle 4 neo-adjuvant combination therapy). In addition there can be no appearance of new lesions or progression of any lesion." (NCT01723774)
Timeframe: 16 weeks

Intervention	Participants (Count of Participants)
Arm 1: PIK3CA Wild Type Cohort	21
Arm 2: PIK3CA Mutant Type Cohort	10
Arm 3: Endocrine Resistant Cohort	16

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Safety of PD 0332991 in Combination in Anastrozole as Measured by Frequency and Grade of Related Adverse Events

The maximum grade for each type of adverse event will be recorded for each patient using the NCI-CTCAE v4.0 coding scheme, and frequency tables will be reviewed to determine patterns. Additionally, the relationship (possibly related, probably related, and definitely related) of the adverse event(s) to the study treatment will be taken into consideration. (NCT01723774)
Timeframe: From start of treatment through 30 days after completion of an estimated 4 months of neoadjuvant therapy

Intervention	Participants (Count of Participants)
	Grade 1/2 anemia	Grade 1/2 dry eye	Grade 1/2 constipation	Grade 1/2 diarrhea	Grade 1/2 dry mouth	Grade 1/2 dyspepsia	Grade 1/2 flatulence	Grade 1/2 gastroesophageal reflux disease	Grade 1/2 gastrointestinal pain	Grade 1/2 mucositis oral	Grade 1/2 nausea	Grade 1/2 oral pain	Grade 1/2 rectal pain	Grade 1/2 stomatitis	Grade 1/2 vomiting	Grade 1/2 chills	Grade 1/2 edema limbs	Grade 1/2 fatigue	Grade 1/2 fever	Grade 1/2 localized edema	Grade 1/2 pain	Grade 1/2 shingles	Grade 1/2 sinusitis	Grade 1/2 urinary tract infection	Grade 1/2 seroma	Grade 1/2 alanine aminotransferase increased	Grade 3/4 alanine aminotransferase increased	Grade 1/2 aspartate aminotransferase increased	Grade 3/4 aspartate aminotransferase increased	Grade 1/2 lymphocyte count decreased	Grade 1/2 neutrophil count decreased	Grade 3/4 neutrophil count decreased	Grade 1/2 platelet count decreased	Grade 1/2 weight loss	Grade 1/2 white blood cell decreased	Grade 3/4 white blood cell decreased	Grade 1/2 anorexia	Grade 1/2 hypocalcemia	Grade 1/2 hypokalemia	Grade 1/2 hyponatremia	Grade 1/2 arthralgia	Grade 1/2 back pain	Grade 1/2 bone pain	Grade 1/2 myalgia	Grade 1/2 osteoporosis	Grade 1/2 dizziness	Grade 1/2 dysgeusia	Grade 1/2 headache	Grade 1/2 memory impairment	Grade 1/2 peripheral motor neuropathy	Grade 1/2 peripheral sensory neuropathy	Grade 1/2 confusion	Grade 1/2 depression	Grade 1/2 insomnia	Grade 1/2 pelvic pain	Grade 1/2 allergic rhinitis	Grade 1/2 cough	Grade 1/2 dyspnea	Grade 1/2 epistaxis	Grade 1/2 nasal congestion	Grade 1/2 postnasal drip	Grade 1/2 sore throat	Grade 1/2 alopecia	Grade 1/2 dry skin	Grade 1/2 hyperhidrosis	Grade 1/2 papulopustular rash	Grade 1/2 pruritus	Grade 1/2 rash maculo-papular	Grade 3/4 rash maculo-papular	Grade 1/2 fever blister	Grade 1/2 itching	Grade 1/2 hot flashes
Arm 1: PIK3CA Wild Type Cohort	4	0	4	4	0	1	1	0	0	9	8	0	1	1	0	2	1	15	3	0	0	1	1	0	0	1	1	1	1	3	14	7	6	1	23	0	2	3	1	1	5	2	1	2	0	3	1	5	1	0	1	0	2	2	1	1	2	0	1	1	1	0	1	2	2	1	1	1	1	1	0	10
Arm 2: PIK3CA Mutant Type Cohort	5	0	3	1	0	1	1	1	0	3	3	0	0	0	0	1	0	8	0	1	0	0	0	0	0	0	1	0	0	0	4	6	5	0	6	1	3	0	0	0	4	1	0	0	1	0	0	0	0	0	0	1	1	0	0	0	0	1	1	0	0	0	4	1	2	0	1	0	0	0	0	7
Arm 3: Endocrine Resistant Cohort	7	1	1	0	1	0	1	0	1	3	10	1	0	0	2	0	0	6	1	0	1	0	0	1	1	0	0	0	0	1	12	13	3	0	11	2	1	0	0	0	0	0	0	1	0	0	0	2	0	1	0	0	0	1	0	0	1	2	1	0	0	1	2	1	0	0	0	0	0	0	1	3

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Safety Profile of Study Therapy During Adjuvant Therapy as Measured by Frequency and Grade of Adverse Event

The maximum grade for each type of adverse event will be recorded for each patient using the NCI-CTCAE v4.0 coding scheme, and frequency tables will be reviewed to determine patterns. Additionally, the relationship (possibly related, probably related, and definitely related) of the adverse event(s) to the study treatment will be taken into consideration. (NCT01723774)
Timeframe: From start of adjuvant therapy through 30 days after completion of adjuvant therapy (estimated to be 2 years)

Intervention	Participants (Count of Participants)
	Grade 1/2 anemia	Grade 1/2 blurred vision	Grade 1/2 watering eyes	Grade 1/2 diarrhea	Grade 1/2 gastritis	Grade 1/2 mucositis oral	Grade 1/2 nausea	Grade 1/2 vomiting	Grade 1/2 fatigue	Grade 1/2 upper respiratory infection	Grade 1/2 bruising	Grade 1/2 aspartate aminotransferase increased	Grade 1/2 lymphocyte count decreased	Grade 3/4 lymphocyte count decreased	Grade 1/2 neutrophil count decreased	Grade 3/4 neutrophil count decreased	Grade 1/2 platelet count decreased	Grade 1/2 white blood cell count decreased	Grade 3/4 white blood cell count decreased	Grade 1/2 hyperglycemia	Grade 1/2 arthralgia	Grade 1/2 alopecia
Adjuvant Continuation	1	1	1	1	1	1	2	1	1	1	1	1	3	2	2	3	1	1	2	1	1	2

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Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 ( PIK3CA Mutant Type Cohort Only)

Complete cell cycle arrest is defined as Ki67 ≤ 2.7% following 2 weeks of neoadjuvant PD 0332991 (NCT01723774)
Timeframe: At cycle 1 day 15 (2 weeks)

Intervention	Participants (Count of Participants)
Arm 2: PIK3CA Mutant Type Cohort	16

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Number of Participants With a PEPI-0 Score

"Preoperative endocrine prognostic index (PEPI) score is derived from four factors assigned a numerical score following neoadjuvant endocrine therapy, including Ki67 expression in the surgical specimen, pathologic tumor size (indicated as T below), lymph node status (indicated as N below), and estrogen receptor (ER) level (indicated as ER Allred below).~PEPI-0 score indicates T1 or T2, N0, Ki67 < 2.7%, ER Allred > 2.~It predicts a low risk of recurrence." (NCT01723774)
Timeframe: At the time of surgery (estimated to be 5 months)

Intervention	Participants (Count of Participants)
Arm 1: PIK3CA Wild Type Cohort	3
Arm 2: PIK3CA Mutant Type Cohort	2
Arm 3: Endocrine Resistant Cohort	1

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Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (Endocrine Resistant Cohort Only)

Complete cell cycle arrest is defined as Ki67 ≤ 2.7% following 2 weeks of neoadjuvant PD 0332991 (NCT01723774)
Timeframe: At cycle 1 day 15 (2 weeks)

Intervention	Participants (Count of Participants)
Arm 3: Endocrine Resistant Cohort	19

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Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (PIK3CA Wild Type Cohort Only)

Complete cell cycle arrest is defined as Ki67 ≤ 2.7% following 2 weeks of neoadjuvant PD 0332991 (NCT01723774)
Timeframe: At cycle 1 day 15 (2 weeks)

Intervention	Participants (Count of Participants)
Arm 1: PIK3CA Wild Type Cohort	23

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Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the number of patients that reported a grade 3 or higher graded adverse event during neoadjuvent treatment. A complete list of all reported adverse events is in the Adverse Events section of the report. (NCT01776008)
Timeframe: Baseline to end of Cycle 4 (28 day cycles)

Intervention	Participants (Count of Participants)
	Grade 3+ Adverse Event	Grade 4+ Adverse Event
Treatment (MK2206, Anastrozole, Goserelin Acetate)	6	2

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Pathological Complete Response Rate

Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach. (NCT01776008)
Timeframe: At time of surgery (up to 3 weeks after 4, 28-day cycles)

Intervention	participants (Number)
Treatment (MK2206, Anastrozole, Goserelin Acetate)	0

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Proportion of Tumour Size Change at 12 Weeks (or Progression if Prior to Week 12)

This is the primary outcome measure in the Randomised Phase IIa part of the study. This is the proportion of tumour size change from baseline to week 12 (or progression if prior to week 12) based on local review of results. (NCT01791985)
Timeframe: 12 weeks

Intervention	Proportion of tumour size change (Mean)
AZD4547	0.08

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Progression Free Survival

Progression Free Survival (PFS) was defined as the time from study enrolment to first evidence of progression. Progression is defined as overall progressive disease identified at follow-up or confirmed disease progression at the end of the trial or death. (NCT01791985)
Timeframe: 42 months

Intervention	months (Median)
AZD4547	3.1

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Number of Participants With Serious Adverse Events (SAEs)

Safety and tolerability of AZD4547 to be used in combination with a standard dose of anastrozole or letrozole, as assessed by Dose limiting toxicity (DLT) This is the primary outcome measure in the Safety Run-In part of the study. (NCT01791985)
Timeframe: Dose limiting toxicity (DLT) assessment window - days 1 to 28 of cycle 1

Intervention	Participants (Count of Participants)
AZD4547	10

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Proportion of Tumour Size Change at 6, 20 and 28 Weeks

Proportion of tumour size change at 6, 20 and 28 weeks to assess the efficacy of AZD4547 in combination with anastrozole or letrozole. This outcome measure is based on local review. (NCT01791985)
Timeframe: 6, 20 and 28 weeks

Intervention	Proportion of tumuour size change (Mean)
	Proportion of tumour size change at week 6	Proportion of tumour size change at week 20	Proportion of tumour size change at week 28
AZD4547	0.04	0.09	0.10

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Objective Response at 6, 12, 20 and 28 Weeks

Objective Response at 6, 12, 20 and 28 weeks to assess the efficacy of AZD4547 in combination with anastrozole or letrozole. The Objective Response Rate (ORR) is defined as the proportion of overall complete response (CR) and overall partial response (PR) among all patients who receive at least one dose of study treatment. This outcome measure is based on local review. (NCT01791985)
Timeframe: 6, 12, 20 and 28 weeks

Intervention	Participants (Count of Participants)
	Objective response at week 6	Objective response at week 12	Objective response at week 20	Objective response at week 28
AZD4547	0	2	3	3

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Tumour Response (RECIST Criteria) at 6, 12, 20 and 28 Weeks

Tumour response (RECIST criteria) at 6, 12, 20 and 28 weeks to assess the efficacy of AZD4547 in combination with anastrozole or letrozole. This outcome measure is based on local review. (NCT01791985)
Timeframe: 6, 12, 20 and 28 weeks

Intervention	Participants (Count of Participants)
	Overall response at week 672008119							Overall response at week 1272008119	Overall response at week 2072008119	Overall response at week 2872008119
	Scan not done or not available	Complete response	Partial response	Stable disease	Progressive disease	Progressive disease before scan	Withdrawn before scan
AZD4547	31
AZD4547	16
AZD4547	0
AZD4547	1
AZD4547	18
AZD4547	8
AZD4547	17
AZD4547	6
AZD4547	2
AZD4547	13
AZD4547	3
AZD4547	26
AZD4547	10
AZD4547	30
AZD4547	9

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Mean Pain50 Assessed at Baseline, 3 Months and 6 Months

Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined. (NCT01814397)
Timeframe: Baseline, 3 months, 6 months

Intervention	kg/cm^2 (Mean)
	Baseline	3 month	6 month
Women Starting AI Therapy	4.3	4.2	4.2

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Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months

To assess conditioned pain modulation, pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. Conditioned pain modulation magnitude was calculated as the difference (second minus first) in the mean of the 3 pain ratings to the test stimulus applied prior to and during the conditioning stimulus. Conditioned pain modulation was assessed at baseline, 3 months, and 6 months. Change over that time period was assessed. Higher conditioned pain modulation values indicate less efficient conditioned pain modulation. (NCT01814397)
Timeframe: Baseline, 3 months, 6 months

Intervention	units on a scale (0-100 pain scale) (Mean)
	baseline	3 months	6 months
Women Starting AI Therapy	7.9	6.3	10.4

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Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment

Patients completed 4 measures at baseline, before aromatase inhibitor therapy initiation. (1) Depression: Center for Epidemiologic Studies-Depression, scores 0-60, higher scores reflect more depression. (2) Pain: 7 day Pain Diary, scores 0-10, higher scores reflect more pain. (3) Fatigue: Multidimensional Fatigue Inventory, scores 4-20, higher scores reflect more fatigue. (4) Sleep: Medical Outcomes Study-Sleep, scores 0-100, higher scores reflect worse sleep. Persistence with aromatase inhibitor therapy was assessed at the 6 month timepoint. Mean baseline values for each measure were calculated for the cohort that persisted with aromatase inhibitor therapy and the cohort that was non-persistent. (NCT01814397)
Timeframe: Baseline patient-reported outcomes measures, 6 month persistence with therapy

Intervention	units on a scale (Mean)
	Baseline depression, discontinuation by 6 mo	Baseline depression, no discontinuation by 6 mo	Baseline sleep, discontinuation by 6 mo	Baseline sleep, no discontinuation by 6 mo	BL general fatigue, discontinuation by 6 mo	BL general fatigue, no discontinuation by 6 mo	BL pain, discontinuation by 6 mo	Baseline pain, no discontinuation by 6 mo
Women Starting AI Therapy	14	6.6	47.1	28.6	16.9	10.6	1.9	1.6

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Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy

Estradiol is being assessed using an ultrasensitive gas chromatography tandem mass spectroscopy-based assay. The lower limit of detection of the assay is 0.625 pg/ml. For patients whose serum estradiol concentrations were below the lower limit of detection, the value of 0.625 pg/ml was used to calculate the mean estradiol concentration and standard deviation at both baseline and 3 months. (NCT01814397)
Timeframe: Baseline, 3 months

Intervention	pg/ml (Mean)
	Baseline	3 months
Women Starting AI Therapy	6.0	0.75

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Effect of Medication on Change in Grip Strength

Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months (NCT01896050)
Timeframe: baseline and 12 months

Intervention	percent change (Mean)
AI Therapy	-7.0
Tamoxifen	0.6

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Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months

Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment (NCT01896050)
Timeframe: baseline and 12 months

Intervention	participants (Number)
Aromatase Inhibitor	37
Tamoxifen	2

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Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy

Change in BMI between baseline and 12 months of endocrine therapy (NCT01896050)
Timeframe: baseline and 12 months

Intervention	kg/m^2 (Mean)
AI Therapy	-0.15
Tamoxifen	2.44

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Overall Response Rate (ORR) in Patients

Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as >= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) >= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria. (NCT02000596)
Timeframe: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months

Intervention	Participants (Count of Participants)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)
Cohort 1: T+P	0	1	1
Cohort 2 - Arm B	0	0	2

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Progression-free Survival (PFS)

Progression Free Survival in treatment cohorts 1 and 2 as well as arms A and B from the time on study until progression of disease or death (NCT02000596)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months

Intervention	weeks (Number)
	Subject 1	Subject 2
Cohort 1: T+P	6	24
Cohort 2 - Arm B	12	24

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Overall Survival (OS)

Overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B from the time on study until death (NCT02000596)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.

Intervention	Months (Number)
	Subject 1	Subject 2
Cohort 2 - Arm B	25	14

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Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0

the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy. in HER2+ MBC patients (NCT02000596)
Timeframe: Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months

Intervention	participants (Number)
	participant 1	participant 2
Cohort 1: T+P	5	5
Cohort 2 - Arm B	2	8

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All GradeTreatment-Related Alopecia Toxicity Rate

All grade treatment-related alopecia toxicity rate is the percentage of participants experiencing at least one grade 1-4 alopecia AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms. (NCT02040857)
Timeframe: AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days.

Intervention	percentage of participants (Number)
Palbociclib With Adjuvant Endocrine Therapy	28

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Grade 3-4 Treatment-Related Neutropenia Toxicity Rate

Grade 3-4 treatment-related neutropenia toxicity rate is the percentage of participants experiencing at least one grade 3-4 neutropenia AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms. (NCT02040857)
Timeframe: AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days.

Intervention	percentage of participants (Number)
Palbociclib With Adjuvant Endocrine Therapy	54

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Rate of Treatment Related Discontinuation

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in all enrolled participants. (NCT02040857)
Timeframe: Evaluate upon completion of combination therapy with endocrine therapy plus palbociclib, up to 2 years of treatment completion.

Intervention	percentage of participants (Number)
Palbociclib With Adjuvant Endocrine Therapy	63

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2-Year Treatment Discontinuation Rate

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored. (NCT02040857)
Timeframe: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.

Intervention	percentage of participants (Number)
Palbociclib With Adjuvant Endocrine Therapy	31

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2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reason due to toxicity, withdrawal of consent to be treated, or other events related to tolerability of all enrolled participants. (NCT02040857)
Timeframe: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.

Intervention	percentage of participants (Number)
Aromatase Inhibitor + Palbociclib	28
Tamoxifen + Palbociclib	35

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All Grade Treatment-Related Fatigue Toxicity Rate

All grade treatment-related fatigue toxicity rate is the percentage of participants experiencing at least one grade 1-4 fatigue AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms. (NCT02040857)
Timeframe: AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days.

Intervention	percentage of participants (Number)
Palbociclib With Adjuvant Endocrine Therapy	76

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Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ

Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31

Intervention	microgram x hour/millilitre (mcg*h/mL) (Geometric Mean)
	PK analysis of tamoxifen	PK analysis of N-DMT	PK analysis of endoxifen
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	2751	2955	115.8
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	2233	3189	119.3

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Effect of Olaparib on Exposure to Tamoxifen - Cmax ss

Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31

Intervention	mcg/mL (Geometric Mean)
	PK analysis of tamoxifen	PK analysis of N-DMT	PK analysis of endoxifen
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	154.2	149.1	5.727
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	130.3	162.9	5.923

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Effect of Olaparib on Exposure to Letrozole - AUC0-τ

Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43

Intervention	mcg*h/mL (Geometric Mean)
Cohort 3 - Letrozole Alone (Treatment Period 2)	2292
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	2167

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Effect of Anastrozole on Exposure to Olaparib - Cmax ss

Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24

Intervention	mcg/mL (Geometric Mean)
Cohort 2 - Olaparib (Treatment Period 1)	9.490
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	8.256

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Effect of Anastrozole on Exposure to Olaparib - AUC0-τ

Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24

Intervention	mcg*h/mL (Geometric Mean)
Cohort 2 - Olaparib (Treatment Period 1)	55.49
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	44.33

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Effect of Tamoxifen on Exposure to Olaparib - Cmax ss

Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31

Intervention	mcg/mL (Geometric Mean)
Cohort 1 - Olaparib (Treatment Period 1)	9.456
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	7.216

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Effect of Olaparib on Exposure to Letrozole - Cmax ss

Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43

Intervention	mcg/mL (Geometric Mean)
Cohort 3 - Letrozole Alone (Treatment Period 2)	118.9
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	111.8

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Effect of Olaparib on Exposure to Anastrozole - Cmax ss

Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24

Intervention	micrograms per millilitre (mcg/mL) (Geometric Mean)
Cohort 2 - Anastrozole Alone (Treatment Period 2)	40.98
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	35.83

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Effect of Letrozole on Exposure to Olaparib - Cmax ss

Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43

Intervention	mcg/mL (Geometric Mean)
Cohort 3 - Olaparib (Treatment Period 1)	10.05
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	10.48

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Effect of Olaparib on Exposure to Anastrozole - AUC0-τ

Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24

Intervention	mcg*h/mL (Geometric Mean)
Cohort 2 - Anastrozole Alone (Treatment Period 2)	696.8
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	582.5

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Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ

Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31

Intervention	mcg*h/mL (Geometric Mean)
Cohort 1 - Olaparib (Treatment Period 1)	62.12
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	42.27

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Effect of Letrozole on Exposure to Olaparib - AUC0-τ

Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios (NCT02093351)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43

Intervention	mcg*h/mL (Geometric Mean)
Cohort 3 - Olaparib (Treatment Period 1)	61.77
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	67.82

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