NCT06179303

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

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: Patients receive FFNP intravenously (IV) and undergo PET/CT imaging at baseline. Patients then receive estradiol orally every 8 hours (Q8H) over a 24-hour period, followed again by FFNP IV and PET/CT imaging. Patients then receive abemaciclib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive endocrine therapy (ET) of the treating physician choice. Patients also receive FDG IV and undergo PET/CT imaging at baseline, with additional diagnostic imaging for tumor assessment every 3 cycles, and undergo blood sample collection throughout the study. After study completion of study, patients are followed every 3 months.

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

Type	Name	Description
DRUG	Abemaciclib	Given PO
DRUG	Anastrozole	Given PO
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo PET/CT
PROCEDURE	Diagnostic Imaging Testing	Undergo clinical imaging for tumor assessment
DRUG	Exemestane	Given PO
OTHER	Fludeoxyglucose F-18	Given IV
DRUG	Fluorine F 18 Fluoro Furanyl Norprogesterone	Given IV
DRUG	Fulvestrant	Given IM injection
BIOLOGICAL	Gonadotropin-releasing Hormone Analog	Given GnRH analog
DRUG	Letrozole	Given PO
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
DRUG	Tamoxifen	Given PO
DRUG	Therapeutic Estradiol	Given PO

Timeline

• Start date: 2024-07-22
• Primary completion: 2027-03-01
• Completion: 2028-06-01
• First posted: 2023-12-21
• Last updated: 2026-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study