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

Trial Profile

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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2018

At a glance

  • Drugs Ribociclib (Primary) ; Letrozole
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-2
  • Sponsors Novare Pharmaceuticals; Novartis
  • Most Recent Events

    • 07 Feb 2018 Results assessing safety and efficacy and providing rationale for FDA approval published in the Clinical cancer research: an official journal of the American Association for Cancer Research
    • 09 Dec 2017 Results assessing efficacy by baseline circulating tumor DNA alterations (n=427) presented at the 40th Annual San Antonio Breast Cancer Symposium
    • 09 Dec 2017 Results reporting subsequent therapies received following discontinuation from MONALEESA-2 presented at the 40th Annual San Antonio Breast Cancer Symposium
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