drugset / Trial / NCT06179303

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

NCT06179303 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-22
Primary completion
2027-03-01
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule — Oral
Subject Fluorine F 18 Fluoro Furanyl Norprogesterone Diagnostic / imaging agent — Intravenous
Background Anastrozole Other / unclassified — Oral
Background Exemestane Small molecule — Oral
Background Fulvestrant Small molecule — Intramuscular
Background Letrozole Other / unclassified — Oral
Background Tamoxifen Small molecule — Oral
Background Therapeutic Estradiol Unknown — Oral