letrozole and Adverse Drug Event studies

Research Excerpts

Excerpt	Relevance	Reference
"In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer."	9.30	Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. ( Abdi, E; Aebi, S; Barbeaux, A; Bernhard, J; Biganzoli, L; Chirgwin, J; Coates, AS; Colleoni, M; Di Lauro, V; Di Leo, A; Foukakis, T; Francis, PA; Gelber, RD; Goldhirsch, A; Gomez, HL; Graas, MP; Graiff, C; Jerusalem, G; Karlsson, P; Luo, W; Maibach, R; Müller, B; Neven, P; Pagani, O; Rabaglio, M; Regan, MM; Ribi, K; Ruhstaller, T; Vorobiof, D, 2019)
"Letrozole radiosensitises breast cancer cells in vitro."	9.14	Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. ( Azria, D; Belkacemi, Y; Coelho, M; Crompton, NE; Fenoglietto, P; Gourgou, S; Gutowski, M; Lemanski, C; Moscardo, CL; Ozsahin, M; Romieu, G; Rosenstein, B; Zaman, K, 2010)
"To investigate the safety and feasibility of performing two consecutive ovarian stimulation cycles with the use of letrozole protocol for fertility preservation in breast cancer patients."	7.79	Safety and feasibility of performing two consecutive ovarian stimulation cycles with the use of letrozole-gonadotropin protocol for fertility preservation in breast cancer patients. ( Bedoschi, G; Moy, F; Oktay, K; Turan, V, 2013)
"In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer."	5.30	Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. ( Abdi, E; Aebi, S; Barbeaux, A; Bernhard, J; Biganzoli, L; Chirgwin, J; Coates, AS; Colleoni, M; Di Lauro, V; Di Leo, A; Foukakis, T; Francis, PA; Gelber, RD; Goldhirsch, A; Gomez, HL; Graas, MP; Graiff, C; Jerusalem, G; Karlsson, P; Luo, W; Maibach, R; Müller, B; Neven, P; Pagani, O; Rabaglio, M; Regan, MM; Ribi, K; Ruhstaller, T; Vorobiof, D, 2019)
"Letrozole radiosensitises breast cancer cells in vitro."	5.14	Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. ( Azria, D; Belkacemi, Y; Coelho, M; Crompton, NE; Fenoglietto, P; Gourgou, S; Gutowski, M; Lemanski, C; Moscardo, CL; Ozsahin, M; Romieu, G; Rosenstein, B; Zaman, K, 2010)
" A meta-analysis revealed an advantage for AIs over tamoxifen in the monotherapy setting for recurrence but not breast cancer mortality, and an advantage in both of these parameters for switching to an AI after several years of tamoxifen."	4.89	Postmenopausal women with hormone receptor-positive breast cancer: balancing benefit and toxicity from aromatase inhibitors. ( Ingle, JN, 2013)
"There may be a relationship between the incidence of vasomotor and arthralgia/myalgia symptoms and treatment outcomes for postmenopausal breast cancer patients with endocrine-responsive disease who received adjuvant letrozole or tamoxifen."	3.80	Symptoms of endocrine treatment and outcome in the BIG 1-98 study. ( Bonnefoi, H; Coates, AS; Cole, BF; Colleoni, M; Ejlertsen, B; Forbes, JF; Gelber, RD; Giobbie-Hurder, A; Goldhirsch, A; Huober, J; Láng, I; Neven, P; Price, KN; Rabaglio, M; Smith, I; Thürlimann, B; Wardley, A; Wu, J, 2014)
"To investigate the safety and feasibility of performing two consecutive ovarian stimulation cycles with the use of letrozole protocol for fertility preservation in breast cancer patients."	3.79	Safety and feasibility of performing two consecutive ovarian stimulation cycles with the use of letrozole-gonadotropin protocol for fertility preservation in breast cancer patients. ( Bedoschi, G; Moy, F; Oktay, K; Turan, V, 2013)

Research

Studies (10)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Average Percent Adherence to Vitamin D Interventio

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (10.00)	29.6817
2010's	9 (90.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Liu, Z	1
Shi, Q	1
Ding, D	1
Kelly, R	1
Fang, H	1
Tong, W	1
Morgan, RE	1
van Staden, CJ	1
Chen, Y	1
Kalyanaraman, N	1
Kalanzi, J	1
Dunn, RT	1
Afshari, CA	1
Hamadeh, HK	1
Ribi, K	1
Luo, W	1
Colleoni, M	2
Karlsson, P	1
Chirgwin, J	1
Aebi, S	1
Jerusalem, G	1
Neven, P	2
Di Lauro, V	1
Gomez, HL	1
Ruhstaller, T	1
Abdi, E	1
Biganzoli, L	1
Müller, B	1
Barbeaux, A	1
Graas, MP	1
Rabaglio, M	2
Francis, PA	1
Foukakis, T	1
Pagani, O	1
Graiff, C	1
Vorobiof, D	1
Maibach, R	1
Di Leo, A	1
Gelber, RD	2
Goldhirsch, A	2
Coates, AS	2
Regan, MM	1
Bernhard, J	1
Turan, V	1
Bedoschi, G	1
Moy, F	1
Oktay, K	1
Ingle, JN	1
Malloch, L	1
Rhoton-Vlasak, A	1
Huober, J	1
Cole, BF	1
Giobbie-Hurder, A	1
Wu, J	1
Ejlertsen, B	1
Bonnefoi, H	1
Forbes, JF	1
Láng, I	1
Smith, I	1
Wardley, A	1
Price, KN	1
Thürlimann, B	1
Shapiro, AC	1
Adlis, SA	1
Robien, K	1
Kirstein, MN	1
Liang, S	1
Richter, SA	1
Lerner, RE	1
Azria, D	1
Belkacemi, Y	1
Romieu, G	1
Gourgou, S	1
Gutowski, M	1
Zaman, K	1
Moscardo, CL	1
Lemanski, C	1
Coelho, M	1
Rosenstein, B	1
Fenoglietto, P	1
Crompton, NE	1
Ozsahin, M	1
Carpenter, R	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)[NCT00651456]	Phase 2/Phase 3	448 participants (Actual)	Interventional	2008-02-29	Completed
A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors[NCT00004205]	Phase 3	8,028 participants (Actual)	Interventional	1998-03-31	Completed
Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors[NCT01509079]	Phase 2	116 participants (Actual)	Interventional	2012-03-31	Completed
A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors[NCT00208273]	Phase 2	150 participants (Actual)	Interventional	2005-01-31	Completed
Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma[NCT02386371]		66 participants (Actual)	Interventional	2014-03-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months (NCT01509079)
Timeframe: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months

Change in Hand Grip Strength

Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale

Intervention	% of adherence for each treatment arm (Number)
Vitamin D3 4000 IU	95
Vitamin D3 600 IU	95

Intervention	pounds (Mean)
Vitamin D3 4000 IU	1.8
Vitamin D3 600 IU	1.0

The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia (NCT01509079)
Timeframe: baseline to 6 months

Change in PROMIS Physical Functioning Questionnaire

Intervention	units on a scale (Mean)
Vitamin D3 4000 IU	-0.2
Vitamin D3 600 IU	-0.5

PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst). (NCT01509079)
Timeframe: baseline to 6 months

Whole Body Bone Mineral Density

Intervention	units on a scale (Mean)
Vitamin D3 4000 IU	0.6
Vitamin D3 600 IU	1.7

GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use (NCT01509079)
Timeframe: From Baseline and 6 months of D3 supplementation

Change in Steady State Concentrations of Serum Anastrazole and Letrozole

Intervention	gm/cm2 (Geometric Least Squares Mean)
Vitamin D3 4000 IU	1.1
Vitamin D3 600 IU	1.12

Difference in steady state concentrations in plasma from baseline to 6 months (NCT01509079)
Timeframe: baseline to 6 months

Intervention	mg/L (Mean)
	anastrozole	letrozole
Vitamin D3 4000 IU	-1.31	2.16
Vitamin D3 600 IU	2.4	-0.83

Article	Year
Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. British journal of cancer, 2019, Volume: 120, Issue:10 Topics: Adult; Aged; Breast Neoplasms; Chemotherapy, Adjuvant; Disease-Free Survival; Drug Administration Sc	2019
Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast cancer research and treatment, 2016, Volume: 155, Issue:3 Topics: Adult; Aged; Anastrozole; Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Arthralgia; Bone De	2016
Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. The Lancet. Oncology, 2010, Volume: 11, Issue:3 Topics: Aged; Aged, 80 and over; Aromatase Inhibitors; Breast Neoplasms; Combined Modality Therapy; Dermatit	2010
Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. The Lancet. Oncology, 2010, Volume: 11, Issue:3 Topics: Aged; Aged, 80 and over; Aromatase Inhibitors; Breast Neoplasms; Combined Modality Therapy; Dermatit	2010
Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. The Lancet. Oncology, 2010, Volume: 11, Issue:3 Topics: Aged; Aged, 80 and over; Aromatase Inhibitors; Breast Neoplasms; Combined Modality Therapy; Dermatit	2010
Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. The Lancet. Oncology, 2010, Volume: 11, Issue:3 Topics: Aged; Aged, 80 and over; Aromatase Inhibitors; Breast Neoplasms; Combined Modality Therapy; Dermatit	2010

Article	Year
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). PLoS computational biology, 2011, Volume: 7, Issue:12 Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da	2011
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. Toxicological sciences : an official journal of the Society of Toxicology, 2013, Volume: 136, Issue:1 Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily	2013
Safety and feasibility of performing two consecutive ovarian stimulation cycles with the use of letrozole-gonadotropin protocol for fertility preservation in breast cancer patients. Fertility and sterility, 2013, Volume: 100, Issue:6 Topics: Adult; Breast Neoplasms; Cohort Studies; Comorbidity; Drug Therapy, Combination; Drug-Related Side E	2013
An assessment of current clinical attitudes toward letrozole use in reproductive endocrinology practices. Fertility and sterility, 2013, Volume: 100, Issue:6 Topics: Aromatase Inhibitors; Attitude of Health Personnel; Attitude to Health; Comorbidity; Drug-Related Si	2013
Symptoms of endocrine treatment and outcome in the BIG 1-98 study. Breast cancer research and treatment, 2014, Volume: 143, Issue:1 Topics: Adult; Aged; Antineoplastic Agents, Hormonal; Breast Neoplasms; Drug-Related Side Effects and Advers	2014

letrozole and Adverse Drug Event