Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

No longer recruiting (closed or complete)Last updated: 30 January 2024

This phase II trial is examining the side effects (if any) that metastatic breast cancer patients experience when taking abemaciclib (an oral drug) with or without foodAn 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Clinical summary

Summary

Patients in this study will be randomised to receive abemaciclib with or without food.

Conditions

This trial is treating people with hormone receptor positive (HR+), HER2- breast cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

No longer recruiting (closed or complete) hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Eli Lilly and Company

Scientific Title

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

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information