Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location

Trial Details

NCT ID
NCT06179303
Phase
PHASE2
Sponsor
University of Washington
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Abemaciclib
  • Anastrozole
  • Biospecimen Collection
  • Computed Tomography
  • Diagnostic Imaging Testing
  • Exemestane
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Men or women with metastatic or locally advanced unresectable breast cancer
  • Histologically confirmed ER+ / HER2-negative, breast cancer who is a candidate for endocrine therapy with pathology from the primary tumor or metas…
  • In the case of bone biopsy which could yield false negative ER or PR status in patients with historically HR+ disease, a patient may be eligible if…
  • Note that baseline PR status by IHC does not influence results of deltaFFNP-PET imaging.

For full eligibility, visit ClinicalTrials.gov.

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