A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

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

The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.

Inclusion Criteria:

• Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

• Have all of the following:

  • Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
  • Prior treatment with chemotherapy for locally advanced or metastatic disease.
  • No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.

• Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.

• Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.

• Have adequate organ function.

• Women of child-bearing potential must have a negative pregnancy test.

• Are able to swallow tablets/capsules.

Exclusion Criteria:

• Are currently receiving treatment in a clinical study involving an investigational product.
• Have a serious concomitant systemic disorder.
• Have symptomatic central nervous system (CNS) malignancy or metastasis.
• Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
• Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
• Have a history of any other cancer.
• Had major surgery within 14 days prior to randomization.
• Are breastfeeding.
• Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.