Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 24, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06179303). This is a study registration, not published results. Lead sponsor: University of Washington. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma. Interventions: DRUG: Abemaciclib; DRUG: Anastrozole; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Diagnostic Imaging Testing; DRUG: Exemestane; OTHER: Fludeoxyglucose F-18; DRUG: Fluorine F 18 Fluoro Furanyl Norprogesterone; DRUG: Fulvestrant; BIOLOGICAL: Gonadotropin-releasing Hormone Analog; DRUG: Letrozole; PROCEDURE: Positron Emission Tomography; DRUG: Tamoxifen; DRUG: Therapeutic Estradiol. Primary outcome measures: Response to abemaciclib + endocrine therapy , Up to 2 years. Brief summary: 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 of tumors that "light up" with FFNP than a PET scan alone can provide.