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postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

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Trial Profile

postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

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

Latest Information Update: 03 Mar 2025

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At a glance

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

Most Recent Events

  • 09 Dec 2024 Planned End Date changed from 16 Feb 2026 to 1 Feb 2026.
  • 01 Nov 2024 According to an Eli Lilly and Company media release, data from this study will be presented at the San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, TX
  • 04 Jun 2024 Primary endpoint has been met. (Progression-Free Survival (PFS), as per Results presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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