RecruitingPhase 2NCT04573231

Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, Androgen Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET/CT

Sponsor

University of Wisconsin, Madison

Enrollment

13 participants

Start Date

May 24, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Breast Cancer HER2-negative Breast Cancer

Summary

The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. The investigators hypothesize that PSMA expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with HER2-negative, AR-positive metastatic breast cancer will be enrolled and be on study for about 3 days.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of PET scan to look at a protein called PSMA in women with metastatic HER2-negative, androgen receptor (AR)-positive breast cancer. PSMA is usually associated with prostate cancer, but researchers want to understand its role in this type of breast cancer. **You may be eligible if...** - You have been diagnosed with metastatic breast cancer that is HER2-negative - Your tumor shows at least 10% androgen receptor (AR) expression - You are able to lie flat and tolerate a PET/CT scan **You may NOT be eligible if...** - You have another active cancer (not breast cancer) - You cannot tolerate or lie flat for a PET/CT scan - You have medical conditions that, in your doctor's opinion, make participation unsafe - You are pregnant or breastfeeding (a negative pregnancy test within 7 days of the scan is required) 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

DRUG18F-DCFPyL

PSMA is highly expressed on prostate cancer and is associated with metastasis and resistance to anti-androgen therapies. Researchers have evaluated the expression of PSMA in the tumor and tumor-associated neovasculature in primary tumors and distant metastases in patients with breast cancer.

Locations(1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

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NCT04573231

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