CDK4/6 Inhibitor
Abemaciclib
Phase
3
Not Enrolling
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*
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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
*
This clinical trial is being conducted globally.
†
Abemaciclib is administered PO.
‡
Standard adjuvant endocrine therapy is administered according to label instructions.
