A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without LY2835219, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without LY2835219, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Jul 2017

At a glance

  • Drugs Abemaciclib (Primary) ; Fulvestrant
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONARCH 2
  • Sponsors Eli Lilly
  • Most Recent Events

    • 10 Jul 2017 According to an Eli Lilly media release, The U.S. Food and Drug Administration (FDA) has granted Priority Review for NDA application for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy.This NDA submission was based on the data from this trial.
    • 03 Jun 2017 Results published in an Eli Lilly and Company Ltd. media release.
    • 02 Jun 2017 Results assessing safety and efficacy of Abemaciclib + fulvestrant, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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