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Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Aug 2026 to Aug 31, 2026
    • Site details revised
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
  2. Primary and study completion pushed from Jul 2026 to Aug 2026v24
  3. Primary and study completion pushed from Jun 2026 to Jul 2027
    • Primary and study completion moved earlier from Jul 2027 to Jul 2026
    v23
  4. Primary and study completion dates: Jun 2026 to Jul 2027v22
  5. Re-verified, no change to tracked fieldsv21
Show 19 earlier versionsHide 19 earlier versions
  1. Primary and study completion dates: Dec 2025 to Jun 2026v20
  2. Primary and study completion dates: Nov 2025 to Dec 2025v19
  3. Site contact updatedv18
  4. Enrollment target: 15 to 13v17
  5. Re-verified, no change to tracked fieldsv16
  6. Primary and study completion dates: Nov 2023 to Nov 2025v15
  7. Re-verified, no change to tracked fieldsv14
  8. Primary and study completion dates: Nov 2022 to Nov 2023v13
  9. Start date changed from estimate of Jun 2021 to May 24, 2021v12
  10. Start date: May 2021 to Jun 2021v11
  11. Start date: Apr 2021 to May 2021v10
  12. Start date: Mar 2021 to Apr 2021v9
  13. Re-verified, no change to tracked fieldsv8
  14. Start date: Feb 2021 to Mar 2021v7
  15. Start date: Jan 2021 to Feb 2021v6
  16. Start date: Dec 2020 to Jan 2021v5
  17. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2020 to Dec 2020
    • Site details revised
    v4
  18. Primary and study completion dates: Oct 2022 to Nov 2022
    • Start date: Oct 2020 to Nov 2020
    v3
  19. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04573231
Lead Sponsor University of Wisconsin, Madison
Conditions
(from sponsor)		 Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov