Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
NCT02278120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 672
Last updated 2024-03-12
Summary
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Conditions
- Advanced Metastatic Breast Cancer
Interventions
- DRUG
-
Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
- DRUG
-
Tamoxifen
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)
- DRUG
-
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
- DRUG
-
Anastrozole
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
- DRUG
-
Goserelin
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
- DRUG
-
Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-20
- Primary Completion
- 2017-08-21
- Completion
- 2023-04-20
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Bulgaria
- Canada
- Colombia
- France
- Germany
- Greece
- Hong Kong
- Hungary
- India
- Italy
- Lebanon
- Malaysia
- Mexico
- Poland
- Portugal
- Russia
- Saudi Arabia
- Singapore
- South Korea
- Spain
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Arab Emirates
Study Locations
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