NCT06059469 PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
| NCT ID | NCT06059469 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jules Bordet Institute |
| Condition | TNBC - Triple-Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-05-30 |
| Primary Completion | 2025-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2022-05-30 with a primary completion date of 2025-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06059469 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying TNBC - Triple-Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06059469 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06059469 currently recruiting?
Yes, NCT06059469 is actively recruiting participants. Contact the research team at geraldine.gebhart@hubruxelles.be for enrollment information.
Where is the NCT06059469 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06059469 clinical trial?
NCT06059469 is sponsored by Jules Bordet Institute. The trial plans to enroll 20 participants.
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