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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply:
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Stage IV (M1), Stage IA, and lymph node-negative breast cancer.
- Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.
- Females who are pregnant or lactating.
- The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
- The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
- The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
- The participant has a serious pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
- The participant has an active bacterial infection, fungal infection, or detectable viral infection or viral load.
- The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.