Clinical trials: Letrozole
Breast Cancer
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in…
- Trial name
- NCT01923168
- Testing
- alpelisib, buparlisib
- Where
- 86 sites in United States, Australia and 15 more
- Volunteers
- 340 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV…
- Trial name
- NCT00960960
- Testing
- Bevacizumab, Pictilisib, Letrozole
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 71 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice…
- Trial name
- BOLERO-6 (NCT01783444)
- Testing
- Capecitabine, Exemestane, Everolimus
- Where
- 83 sites in United States, Argentina and 16 more
- Volunteers
- 309 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer.
- Trial name
- FACE (NCT00248170)
- Testing
- Letrozole, Anastrozole
- Where
- 259 sites in United States, Australia and 18 more
- Volunteers
- 4,172 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fasted conditions.
- Trial name
- NCT01367652
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Breast Cancer
Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study.
- Trial name
- NCT00880009
- Testing
- Bosutinib, Letrozole
- Where
- 11 sites in United States, Belgium and 5 more
- Volunteers
- 16 people
- Sponsor
- Pfizer
Metastatic ER+ Her2- Breast Cancer, Postmenopausal
A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in…
- Trial name
- NCT01381874
- Testing
- Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane, Abiraterone acetate + Prednisone or Prednisolone
- Where
- 81 sites in United States, Belgium and 10 more
- Volunteers
- 297 people
- Sponsor
- Janssen Research & Development, LLC
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Advanced Breast Cancer Female
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate…
- Trial name
- NCT02600923
- Testing
- Palbociclib, Letrozole
- Where
- 24 sites in Argentina, Brazil and 2 more
- Volunteers
- 131 people
- Sponsor
- Pfizer
Breast Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer.
- Trial name
- NCT04707196
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI), Fulvestrant
- Where
- 15 sites in India
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Healthy
Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)
This is a Phase I, open label, dose escalation study designed to evaluate the pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole ISM® at different strengths in voluntary healthy post…
- Trial name
- NCT03401320
- Testing
- Letrozole ISM
- Where
- Czechia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Rovi Pharmaceuticals Laboratories
Metastatic Breast Cancer
Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment
The course of the disease in female patients with metastatic mammary carcinoma can vary greatly. In this connection, the individual prognosis depends on a complex interaction of tumor- and patient-related factors.
- Trial name
- NCT00241046
- Testing
- Letrozole
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.
- Trial name
- NCT00237224
- Testing
- Letrozole
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer
GB491-005 is a multicenter, open-label, phase Ib Clinical Trial study to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GB491 in combination with Letrozole in…
- Trial name
- NCT05337657
- Testing
- GB491+Letrozole
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
The purpose of this study is to investigate the efficacy and safety of HRS-6209 in combination with letrozole compared with dalpciclib or palbociclib in combination with aromatase inhibitor in patients with advanced or metastatic…
- Trial name
- NCT07894328
- Testing
- HRS-6209 + Letrozole, Dalpciclib/Palbociclib + Letrozole/Anastrozole
- Where
- China
- Volunteers
- 1,050 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer
This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness.
- Trial name
- NCT01199367
- Testing
- KW-2450 in combination with lapatinib and letrozole
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy
Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fed conditions.
- Trial name
- NCT00648154
- Testing
- Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Osteoporosis, Postmenopausal
Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received…
- Trial name
- NCT00332709
- Testing
- Letrozole, Zoledronic acid
- Where
- 23 sites in Germany
- Volunteers
- 83 people
- Sponsor
- Novartis
Breast Cancer
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who…
- Trial name
- NCT01225172
- Testing
- BMS-754807, letrozole
- Where
- 21 sites in United States
- Volunteers
- 77 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).
- Trial name
- NCT01872260
- Testing
- LEE011, Letrozole, BYL719
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 259 people
- Sponsor
- Novartis Pharmaceuticals