CDK4/6 Inhibitor
Abemaciclib
Phase
2
Not Enrolling
An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone-Receptor-Positive, HER2-Negative Metastatic Breast Cancer*
Related Resources:
Key Inclusion Criteria
- Hormone-receptor-positive (HR+), HER2-negative metastatic breast cancer (MBC)
- Have all of the following:
- Recurrent, locally advanced, unresectable or metastatic breast cancer (MBC) with disease progression following antiestrogen therapy
- Prior treatment with chemotherapy for locally advanced or metastatic disease
- No prior treatment with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
- Discontinued all previous treatments for cancer and recovered from the acute effects of therapy
- Adequate organ function
- Women of child-bearing potential must have a negative pregnancy test
- Able to swallow tablets/capsules
Key Exclusion Criteria
- Currently receiving an investigational treatment
- Serious preexisting medical conditions as judged by the investigator
- History of syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
- Symptomatic central nervous system malignancy or metastasis
- History of any other cancer
- Major surgery within 14 days prior to the first dose of study drug
- Breastfeeding
- Received investigational therapy within 14 or 21 days prior to the first dose of study drug for nonmyelosuppressive or myelosuppressive agents, respectively
- Symptomatic HIV infection or activated/reactivated hepatitis A, B, or C
*
This clinical trial is being conducted outside of the United States.
†
Abemaciclib is administered PO Q12H.
