For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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


Have all of the following:


  1. Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
  2. Prior treatment with chemotherapy for locally advanced or metastatic disease.
  3. No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
  4. Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
  5. Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
  6. Have adequate organ function.
  7. Women of child-bearing potential must have a negative pregnancy test.
  8. Are able to swallow tablets/capsules.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Are currently receiving treatment in a clinical study involving an investigational product.
  2. Have a serious concomitant systemic disorder.
  3. Have symptomatic central nervous system (CNS) malignancy or metastasis.
  4. Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
  5. Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  6. Have a history of any other cancer.
  7. Had major surgery within 14 days prior to randomization.
  8. Are breastfeeding.
  9. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Metastatic Breast Cancer

Age (in years)

18+

Phase

Phase 2

Participants needed

72

Est. Completion Date

Sep 20, 2023

Treatment type

Interventional


Sponsor

Eli Lilly and Company

ClinicalTrials.gov identifier

NCT03703466

Study number

I3Y-MC-JPCP

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