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Closed (no longer recruiting)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

Clinical summary

Summary

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

Conditions

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

Cancer

Breast Cancers Breast

Age

People18+

Phase

II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

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 have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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