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NCT04573231 · ClinicalTrials.gov registry record · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
A Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04573231: Recruiting Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by University of Wisconsin, Madison.
NCT04573231 is a Phase 2 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 13 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04573231, a Phase 2 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 18F-DCFPyL
Study Locations (1)
Wisconsin
- University of Wisconsin School of Medicine and Public Health - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-05-24 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT04573231 shows while recruiting
NCT04573231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which 18F-DCFPyL is the first listed.
NCT04573231 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04573231 about?
NCT04573231 is a clinical study titled "Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer". 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. ...
What is the current status of trial NCT04573231?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-05-24. Estimated completion is 2026-06.
What conditions does trial NCT04573231 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-Negative Breast Cancer.
What interventions are being tested in trial NCT04573231?
The interventions under investigation include: 18F-DCFPyL (DRUG).
Who is sponsoring clinical trial NCT04573231?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04573231 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04573231's enrollment target sits among peer trials
13 1161st of 1224 higher than 59 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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