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

• Status: Active, not recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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.