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: 17 Oct 2017

At a glance

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

    • 28 Sep 2017 Based on the data from this trial, the US FDA has approved Verzenio (abemaciclib) in combination with fulvestrant to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones (endocrine therapy), as reported in a media release.
    • 12 Sep 2017 Results assessing efficacy and safety of abemaciclib plus fulvestrant in exploratory cohort of HR1/HER2-endocrine therapy naive, were presented at the 42nd European Society for Medical Oncology Congress.
    • 29 Aug 2017 According to an Eli Lilly media release, results from this trial will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress.
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