Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Official Title

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

Summary:

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Trial Description

Primary Outcome:

  • Invasive Disease Free Survival (IDFS)
Secondary Outcome:
  • IDFS for Participants with Ki67 Index ≥20%
  • Distant Relapse-Free Survival (DRFS)
  • Overall Survival (OS)
  • Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
  • Change from Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)
  • Change from Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
  • Change from Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Change from Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society