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A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Trial Profile

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

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

Latest Information Update: 21 Mar 2024

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At a glance

  • Drugs Abemaciclib (Primary) ; Aromatase inhibitors; Hormone modulators; LHRH receptor agonists; Tamoxifen
  • Indications Early breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MonarchE
  • Sponsors Eli Lilly and Company; Eli Lilly Japan
  • Most Recent Events

    • 09 Jan 2024 5-year efficacy results from a prespecified overall survival (OS) interim analysis, published in the Journal of Clinical Oncology
    • 07 Dec 2023 According to an Eli Lilly and Company media release, based on the data of this study, the Health Canada has authorized the label expansion of Verzenio (abemaciclib) to include the full intent-to-treat (ITT) population.
    • 06 Dec 2023 According to a Natera media release, an analysis of an expanded cohort is ongoing.
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