Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-DCFPyL.
- Who it may be relevant to
- Registry conditions: Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- PSMA Expression as measured by 18F-DCFPyL SUV [Time frame: up to 3 days]
Secondary outcome measures (3)
- Expression of PSMA in CTCs [Time frame: up to 2 weeks]
- Expression of PSMA in diagnostic metastatic tissue [Time frame: up to 3 days]
- Change in PSMA Expression on CTCs after 2 weeks of bicalutamide [Time frame: baseline and up to 2 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Wisconsin School of Medicine and Public Health — Madison
Identifiers
NCT: NCT04573231 · 2020-0949 · A539300 · SMPH/RADIOLOGY/RADIOLOGY · Protocol Version 12/12/2025 · NCI-2020-07434 · 2020-0949