TNBC - Triple-Negative Breast CancerPhase 2PRISMANCT06059469
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
A Phase 2 study testing Ga-PSMA PET/CT in people with TNBC - Triple-Negative Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Ga-PSMA PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 30 May 2022to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels
Loubna Taraji Schiltz, loubna.taraji@hubruxelles.be
About this study
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.
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.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Ga-PSMA PET/CT
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-PSMA PET/CTDiagnostic test
Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT | Experimental | Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT Receives: Diagnostic Test: Ga-PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess PSMA expression in progressive metastatic TNBC patients
uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.
Measured: once at baseline prior to the start of the new anti cancer treatment
Secondary outcomes (1)
Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).
Matching between FDG and PSMA-labelled radiotracers uptake: on PSMA PET/CT and 18F-FDG PET/CT images, each lesion will be identified and faced with the other images. Each imaging pair will be classified as complete match, partial match or no match between the different types of imaging
Measured: once at baseline prior to the start of the new anti cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start30 May 2022
- Primary completion2 Jun 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059469
- Sponsor's protocol ID
- IJBMNdTNBC
- Acronym
- PRISMA
- Status last verified
- Mar 2025
- First submitted
- 6 Sep 2023
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06059469
- Acronym / sponsor ID
- PRISMA / IJBMNdTNBC
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT | Experimental | Diagnostic Test: Ga-PSMA PET/CTPatients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-PSMA PET/CTPatient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment | Diagnostic test | Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT |
Primary outcome
Assess PSMA expression in progressive metastatic TNBC patients
Time frame: once at baseline prior to the start of the new anti cancer treatment
uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.
1 secondary outcome
Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).
Time frame: once at baseline prior to the start of the new anti cancer treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ga-PSMA PET/CT in people with TNBC - Triple-Negative Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Géraldine Gebhart, MD (025413095, geraldine.gebhart@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess PSMA expression in progressive metastatic TNBC patients (time frame: once at baseline prior to the start of the new anti cancer treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.