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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
CDK4/6 Inhibitor
Abemaciclib
Phase
3
Active, not recruiting
Recruiting Info
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 Cancera
Related Resources:
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Key Inclusion Criteria
  • Hormone-receptor-positive (HR+), HER2-negative, node-positive, early-stage resected invasive breast cancer without evidence of distant metastases
  • Underwent definitive surgery of the primary breast tumor(s) within 16 months of randomization
  • Availability of tumor tissue from breast or lymph node for biomarker analysis prior to randomization
  • Pathologic axillary lymph node involvement with at least one of the following:
    • Four or more positive axillary lymph nodes
    • Tumor size of at least 5 cm
    • Grade 3 tumor defined as at least 8 points on the Bloom-Richardson grading system
    • Ki-67 index by central analysis of ≥20% on untreated breast tissue
  • Up to 12 weeks of endocrine therapy following the last nonendocrine therapy
  • Recovery (Grade ≤1) from the acute effects of chemotherapy and radiotherapy, and surgical side effects following definitive breast surgery
  • Female (regardless of menopausal status) or male ≥18 years of age, or per local regulations
  • Negative blood pregnancy test and must agree to use highly effective contraceptive methods
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Able to swallow oral medications
Key Exclusion Criteria
  • Metastatic disease (including contralateral axillary lymph nodes) or lymph node-negative breast cancer
  • Inflammatory breast cancer
  • History of breast cancer (except ipsilateral ductal carcinoma in situ treated by locoregional therapy alone) ≥5 years prior to study entry
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of 5 years, or at low risk of recurrence if diagnosed within the last 5 years
  • Pregnant or breastfeeding
  • Previous treatment with any cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor
  • Currently receiving concurrent exogenous hormone therapy
  • Previously received endocrine therapy for breast cancer prevention
  • Serious preexisting medical conditions as judged by the investigator 
  • History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest
  • History of venous thromboembolic event
  • Active systemic infections, or fungal or detectable viral infections requiring systemic therapy
  • Received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer
a
This clinical trial is being conducted globally. 
b
Administered orally.
c
Administered according to label instructions.
For information on trial enrollment, locations, and more, call 1-877-285-4559.
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