RecruitingPhase 2NCT06179303

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


Sponsor

University of Washington

Enrollment

60 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether special imaging scans (PET/CT) can predict how well a breast cancer drug called abemaciclib will work. Abemaciclib is a targeted pill used for hormone receptor-positive, HER2-negative breast cancer — a common type that is fueled by estrogen but not by the HER2 protein. **You may be eligible if...** - You have metastatic or locally advanced breast cancer that cannot be surgically removed - Your cancer is ER-positive and HER2-negative (your doctor can confirm this) - You are being considered for hormone therapy combined with abemaciclib - You are a man or woman (any age) **You may NOT be eligible if...** - Your breast cancer is HER2-positive or hormone receptor-negative (triple-negative) - You are not a candidate for the drug abemaciclib - You are unable to undergo imaging scans required for the study - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

Given PO

DRUGAnastrozole

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo PET/CT

PROCEDUREDiagnostic Imaging Testing

Undergo clinical imaging for tumor assessment

DRUGExemestane

Given PO

OTHERFludeoxyglucose F-18

Given IV

DRUGFluorine F 18 Fluoro Furanyl Norprogesterone

Given IV

DRUGFulvestrant

Given IM injection

BIOLOGICALGonadotropin-releasing Hormone Analog

Given GnRH analog

DRUGLetrozole

Given PO

PROCEDUREPositron Emission Tomography

Undergo PET/CT

DRUGTamoxifen

Given PO

DRUGTherapeutic Estradiol

Given PO


Locations(2)

Siteman Cancer Center at Washington University

St Louis, Missouri, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06179303


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