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Clinical trial

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

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Last updated:25th Apr 2023
Status: COMPLETED
Identifier: NCT01958021
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)