Breast Cancer

CDK4 & 6 Inhibitor

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*

show modal icon NCT03703466
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 (CDK) 4 and 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.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.