Evaluating PSMA in HER2-negative, AR-positive 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
This study is testing if measuring a specific protein called PSMA in patients with HER2-negative, AR-positive metastatic breast cancer can help understand their resistance to certain hormone therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT04573231 on ClinicalTrials.gov |
What this trial studies
This research aims to assess the expression of prostate specific membrane antigen (PSMA) in patients with HER2-negative, androgen receptor-positive metastatic breast cancer. The study will utilize 18F-DCFPyL PSMA-based PET/CT imaging to quantify PSMA expression as a non-invasive biomarker. The investigators hypothesize that higher PSMA expression may correlate with resistance to anti-androgen therapies, specifically bicalutamide. A total of 15 participants will be enrolled for approximately three days to evaluate these relationships.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with metastatic HER2-negative breast cancer with androgen receptor expression of 10% or greater.
Not a fit: Patients with other active malignancies or those unable to tolerate PET/CT imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are most likely to benefit from anti-androgen therapies in metastatic breast cancer.
How similar studies have performed: While the approach of evaluating PSMA in breast cancer is relatively novel, similar methodologies have shown promise in prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Amy Fowler, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Radiology Studies
- Email: radstudy@uwhealth.org
- Phone: 608-282-8349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.