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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date: December 17, 2013
Actual Primary Completion Date: January 29, 2016
Estimated Study Completion Date: August 31, 2021

Arms:
- Experimental: LEE011 + letrozole
- Placebo Comparator: Placebo + letrozole


Related journal:
- Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.