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Clinical trial

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

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Last updated:20th Nov 2014
Identifier: NCT02278120

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

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

Category Value
Date last updated at source 2018-07-18
Study type(s) Interventional
Expected enrolment 660
Study start date 2014-11-20
Estimated primary completion date 2017-08-20

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