Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Status
RECRUITING
Phase
PHASE2
Age
≥ 18 Years
Enrollments
13Conditions
Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast CancerDrugs
18F-DCFPyLSummary
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.
Detailed Description
Primary Objective:
* To evaluate the expression of PSMA via 18F-DCFPyL PSMA-based PET/CT in patients with metastatic HER2-negative, AR-positive breast cancer. Expression of PSMA will be quantified using PSMA-based PET imaging using a novel agent, 18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature in HER2-negative, AR-positive metastatic breast cancer.
Secondary Objectives:
* PSMA PET will be compared with the expression of PSMA in CTCs and diagnostic metastatic tissue from patients with HER2-negative, AR-positive metastatic breast cancer.
* PSMA expression will be correlated with clinical benefit (objective response and progression-free survival) to bicalutamide and ribociclib for patients enrolled in NCT03090165.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Radiology Studies
- 608-282-8349
- [email protected]
Principal Investigator
- Steve Y Cho, MD
Eligibility Criteria
Inclusion Criteria:
* Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%
Exclusion Criteria:
* Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.
* Unable to lie flat during or tolerate PET/CT
* Participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
* Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET/CT
Study Plan
18F-DCFPyL PSMA-based PET/CT
EXPERIMENTAL
* 18F-DCFPyL whole body PET/CT scann* Review of relevant imaging and medical record informationn* Blood draw for circulating tumor cells (CTCs)n* Analysis of diagnostic tissue specimens
DRUG:
18F-DCFPyLDescription:
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.
Outcome Measures
Primary Outcome Measures
PSMA Expression as measured by 18F-DCFPyL SUV
Secondary Outcome Measures
Expression of PSMA in CTCs
Expression of PSMA in diagnostic metastatic tissue
Change in PSMA Expression on CTCs after 2 weeks of bicalutamide
Timeline
Last Updated
January 17, 2025Start Date
October 5, 2020Today
November 9, 2025Completion Date ( Estimated )
November 1, 2025
Sponsors of this trial
Lead Sponsor
University of Wisconsin, Madison
RECRUITING 
≥ 18 Years