Study on Using Functional Imaging to Predict Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06179303

Provider View

This clinical trial is testing whether a special type of imaging, called FFNP-PET/CT, can predict how well patients with advanced hormone receptor-positive, HER2-negative breast cancer will respond to the drug abemaciclib combined with hormone therapy.

Patient Parameters

Program Overview

The purpose of this study is to see if a special imaging technique, FFNP-PET/CT, can accurately predict how well patients with advanced hormone receptor-positive, HER2-negative breast cancer respond to treatment with abemaciclib and hormone therapy. Abemaciclib is a medication that blocks certain proteins to help stop cancer cells from growing. Hormone therapy works by adding, blocking, or removing hormones that can cause cancer to grow. FFNP-PET/CT is a type of imaging that uses a special agent to provide detailed pictures of tumors, potentially offering more precise information than standard PET scans.

Description

In this study, patients will receive a special imaging agent called FFNP through an IV and undergo PET/CT scans at the start. They will then take a hormone called estradiol by mouth every 8 hours for one day, followed by another FFNP IV and PET/CT scan. Patients will take abemaciclib by mouth twice a day for 28-day cycles, continuing as long as the cancer does not progress or cause unacceptable side effects. Patients will also receive hormone therapy chosen by their doctor. Additional imaging and blood tests will be conducted throughout the study to monitor the cancer's response. After completing the study, patients will have follow-up visits every three months.

Eligibility Criteria

Inclusion Criteria

  • Men or women with advanced breast cancer that cannot be surgically removed.
  • Cancer must be hormone receptor-positive (ER+) and HER2-negative, confirmed by lab tests.
  • If premenopausal, must have been treated with a GnRH agonist for at least 6 weeks before imaging.
  • Cancer must be present in at least one non-liver site and measurable by specific criteria.
  • No limit on previous hormone therapies, but only one prior chemotherapy in the metastatic setting is allowed.
  • Must have recovered from previous treatments and meet specific health criteria, including blood counts and organ function.
  • Must be 18 years or older.
  • Women of childbearing potential must use effective birth control during the study.
  • Must be able to understand and sign a consent form.
  • Must agree to provide previous tumor samples for research.
  • No other active cancers unless treatment was completed over two years ago and there is no evidence of disease.

Exclusion Criteria

  • Previous treatment with abemaciclib in the metastatic setting or within two years of completing adjuvant abemaciclib.
  • Cancer that has only spread to the liver.
  • Currently taking other experimental drugs.
  • Untreated or unstable brain metastases.
  • Allergic reactions to similar drugs used in the study.
  • Uncontrolled illnesses like active infections or heart problems.
  • Pregnant or breastfeeding women.
  • HIV-positive patients with low CD4+ counts or recent serious infections, unless on effective antiretroviral therapy.

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