Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

Brief Summary:
This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

Detailed Description:
The purpose of this study is to assess the efficacy of LEE011, as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Actual Study Start Date: November 20, 2014
Actual Primary Completion Date: August 20, 2017
Estimated Study Completion Date: September 27, 2019

Arm:
- Experimental: LEE011 + NSAI/tamoxifen + goserelin
- Placebo Comparator: LEE011 placebo + NSAI/tamoxifen+ goserelin