A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2017

At a glance

  • Drugs Abemaciclib (Primary) ; Anastrozole; Letrozole
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONARCH 3
  • Sponsors Eli Lilly
  • Most Recent Events

    • 12 Oct 2017 According to a company media release, the US FDA has granted Priority Review designation for Eli Lilly's NDA for abemaciclib (Verzenio™) as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The NDA was based upon the positive interim results from this trial.
    • 06 Oct 2017 Interim results presented in an Eli Lilly media release.
    • 06 Oct 2017 According to an Eli Lilly media release, final PFS results are expected at the end of the year and will be presented at a scientific congress in the first half of 2018.
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