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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

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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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2024

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At a glance

  • Drugs Abemaciclib (Primary) ; Anastrozole; Fulvestrant; Letrozole
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONARCH plus
  • Sponsors Eli Lilly and Company

    • Most Recent Events

    • 05 Dec 2023 According to an Eli Lilly and Company media release, data from this study will be presented at the 2023 San Antonio Breast Cancer Symposium.
    • 11 Sep 2023 Planned End Date changed from 20 Sep 2023 to 31 Dec 2024.
    • 08 Aug 2022 Planned End Date changed from 28 Feb 2023 to 20 Sep 2023.

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