Clinical trial
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Brief Summary:
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Detailed Description:
The primary purpose of this study was to assess the efficacy of LEE011, as measured by progression free survival (PFS), in postmenopausal women with HR positive, HER2 negative advanced breast cancer who received no prior treatment for advanced disease.
Official Title:
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Intervention / Treatment:
- Drug: LEE011
- Drug: Letrozole
- Drug: LEE011 Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2013-12-17 |
| Primary Completion (Actual) | 2016-01-29 |
| Study Completion (Actual) | 2023-03-16 |
| Enrollment (Actual) | 668 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CLEE011A2301
2013-003084-61 (EudraCT Number) |