Assessing PSMA in Patients with Progressive Triple-Negative Breast Cancer
Official title: 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.
Run by Jules Bordet Institute · NCT06059469 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | May 30, 2022 |
| Main results expected | June 2, 2025 |
| Study ends | December 2025 |
| Registry record updated | July 18, 2025 |
| Trial ID | NCT06059469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with confirmed progressive metastatic TNBC and measurable disease on recent imaging.
✕Probably not a fit
Patients with skin-only metastatic disease or other active neoplastic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of using PSMA imaging in breast cancer is relatively novel, similar studies in other cancers have shown promising results.
Who can join: the full rules
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 it's running
-
Institut Jules Bordet
Brussels, Belgium Recruiting
Study contacts
- Study coordinator: Géraldine Gebhart, MD
- Email: geraldine.gebhart@hubruxelles.be
- Phone: 025413095
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This imaging study tests how well the imaging agent works in people with metastatic urothelial cancer, various breast cancers, or NSCLC.
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Radiotherapy with chemotherapy plus adebrelimab and bevacizumab for TNBC with brain metastases
This phase II study tests a combination of radiotherapy, cisplatin or carboplatin, adebrelimab, and bevacizumab in adults with triple-negative breast cancer that has spread to the brain.
-
First-line therapy for advanced TNBC with QL1706, plus anlotinib and nab-paclitaxel
This study tests whether a combination of QL1706 with anlotinib and nab-paclitaxel can help people with newly diagnosed, advanced triple-negative breast cancer.
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Patient-reported outcomes of sacituzumab govitecan versus physician‑choice chemotherapy in Chinese metastatic HER2‑negative breast cancer
This project will test whether sacituzumab govitecan or physician‑choice chemotherapy leads to better patient‑reported quality of life and symptoms for Chinese adults aged 18–75 with metastatic HER2‑negative breast cancer who progressed after first‑line treatment.
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Short-course SBRT plus toripalimab and chemotherapy for chemo-resistant triple-negative breast cancer
This trial will try a short, high-precision course of breast radiation followed by toripalimab with paclitaxel and carboplatin for people whose triple-negative breast cancer did not shrink after initial chemotherapy to see if it can eliminate invasive cancer at surgery.
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Neoadjuvant chemotherapy with sintilimab and bevacizumab for triple-negative breast cancer
This trial will try adding the immunotherapy drug sintilimab and the blood‑vessel blocker bevacizumab to pre-surgery chemotherapy for women with stage II–III triple‑negative breast cancer to see if more tumors disappear completely before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.