Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
18F-DCFPyL
DrugPSMA 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.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: 18F-DCFPyL PSMA-based PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PSMA Expression as measured by 18F-DCFPyL SUV
Quantitative analysis of 18F-DCFPyL PSMA PET uptake will be performed at the lesion-level. Standardized uptake values (SUV) will be measured by manually drawing a region of interest (ROI) to encompass the entire lesion guided by the lesion extent visualized on conventional imaging. PET SUV based quantitative tumor uptake parameters will be obtained.
Time frame
up to 3 daysSecondary outcomes
1
Expression of PSMA in CTCs
Expression of PSMA in CTCs will be measured via immunofluorescence.
Time frame
up to 2 weeks2
Expression of PSMA in diagnostic metastatic tissue
PSMA expression in tumors will be semi-quantitatively scored by a study pathologist using published methods including separate assessment of tumor-associated and non-tumor vasculature, with the endothelium highlighted by a CD31 immunostain to facilitate definitive recognition.
Time frame
up to 3 days3
Change in PSMA Expression on CTCs after 2 weeks of bicalutamide
The change in PSMA expression on CTCs will be measured pre and post treatment via immunofluorescence.
Time frame
baseline and up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov