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Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT04573231
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
29.3
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Primary Objective:
  • To evaluate the expression of PSMA via 18F-DCFPyL PSMA-based PET/CT in patients with metastatic HER2-negative, AR-positive breast cancer. Expression of PSMA will be quantified using PSMA-based PET imaging using a novel agent, 18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature in HER2-negative, AR-positive metastatic breast cancer.
Secondary Objectives:

  • PSMA PET will be compared with the expression of PSMA in CTCs and diagnostic metastatic tissue from patients with HER2-negative, AR-positive metastatic breast cancer.

  • PSMA expression will be correlated with clinical benefit (objective response and progression-free survival) to bicalutamide and ribociclib for patients enrolled in NCT03090165.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Phase 2, single-center, open-label studyPhase 2, single-center, open-label study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
May 24, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-DCFPyL PSMA-based PET/CT

18F-DCFPyL whole body PET/CT scan Review of relevant imaging and medical record information Blood draw for circulating tumor cells (CTCs) Analysis of diagnostic tissue specimens

Drug: 18F-DCFPyL
PSMA 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.

Outcome Measures

Primary Outcome Measures

  1. PSMA Expression as measured by 18F-DCFPyL SUV [up to 3 days]

    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.

Secondary Outcome Measures

  1. Expression of PSMA in CTCs [up to 2 weeks]

    Expression of PSMA in CTCs will be measured via immunofluorescence.

  2. Expression of PSMA in diagnostic metastatic tissue [up to 3 days]

    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.

  3. Change in PSMA Expression on CTCs after 2 weeks of bicalutamide [baseline and up to 2 weeks]

    The change in PSMA expression on CTCs will be measured pre and post treatment via immunofluorescence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Wisconsin School of Medicine and Public Health Madison Wisconsin United States 53705

Sponsors and Collaborators

  • University of Wisconsin, Madison

Investigators

  • Principal Investigator: Steve Y Cho, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT04573231
Other Study ID Numbers:
  • UW20035
  • A539300
  • SMPH/RADIOLOGY/RADIOLOGY
  • Protocol Version 3/5/2021
  • NCI-2020-07434
  • 2020-0949
First Posted:
Oct 5, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Apr 6, 2022