A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer

Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Oct 2017

At a glance

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

    • 03 Jun 2017 According to an Eli Lilly and Company Ltd. media release, this trial will support registration of abemaciclib in China.
    • 13 Dec 2016 Status changed from not yet recruiting to recruiting.
    • 02 Nov 2016 Planned End Date changed from 1 Dec 2019 to 1 Jan 2020.
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