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A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

Trial Profile

A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

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

Latest Information Update: 13 Jan 2025

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At a glance

  • Drugs Abemaciclib (Primary) ; Loperamide; Tamoxifen
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Therapeutic Use
  • Acronyms nextMONARCH 1
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 09 Jan 2025 Planned End Date changed from 30 Dec 2024 to 1 Dec 2025.
  • 27 Oct 2023 Results deriving baseline and end-of-treatment plasma samples from patients in MONARCH 3 and nextMONARCH (monotherapy arms) to identify somatic genomic alterations, lished in the Clinical Cancer Research
  • 11 Sep 2023 Planned End Date changed from 20 Sep 2023 to 30 Dec 2024.

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