Assessing PSMA in Patients with Progressive Triple-Negative Breast Cancer
PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
This study is testing if a special imaging technique can help find a targeted treatment for patients with advanced triple-negative breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06059469 on ClinicalTrials.gov |
What this trial studies
This study evaluates the expression of Prostate-Specific Membrane Antigen (PSMA) in patients with progressive metastatic triple-negative breast cancer (TNBC) using Ga-PSMA PET/CT imaging. The aim is to assess the feasibility of molecular radionuclide therapy with Lutetium-177 in patients who have measurable disease identified on prior imaging. Participants will undergo PSMA PET/CT before starting their next line of treatment to determine the potential for targeted therapy. This is a single-center, prospective study designed to gather data on PSMA expression in TNBC lesions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with confirmed progressive metastatic TNBC and measurable disease on recent imaging.
Not a fit: Patients with skin-only metastatic disease or other active neoplastic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new targeted treatment options for patients with refractory metastatic TNBC.
How similar studies have performed: While the approach of using PSMA imaging in breast cancer is relatively novel, similar studies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure * Women with ≥ 18 years-old * Eastern Cooperative Oncology Group Performance Status of 0 to 2 * Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT. * Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation Exclusion Criteria: * Pregnant or lactating patients * Other active neoplastic disease * Treatment by another molecule that is the object of investigation within 30 days * Skin only metastatic disease * Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study
Where this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Géraldine Gebhart, MD
- Email: geraldine.gebhart@hubruxelles.be
- Phone: 025413095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.