RECRUITING

Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, Androgen Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET/CT

Quick Facts

Study Start:2021-05-24
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04573231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%
  1. * Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.
  2. * Unable to lie flat during or tolerate PET/CT
  3. * 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
  4. * Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET/CT

Contacts and Locations

Study Contact

Gemma Gliori
CONTACT
608-262-7269
radstudy@uwhealth.org

Principal Investigator

Steve Y Cho, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Steve Y Cho, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-24
Study Completion Date2025-11

Study Record Updates

Study Start Date2021-05-24
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • HER2-negative Breast Cancer
  • Metastatic Breast Cancer