PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.

NCT ID: NCT06059469

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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TNBC - Triple-Negative Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT

Patients with progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT

Group Type EXPERIMENTAL

Ga-PSMA PET/CT

Intervention Type DIAGNOSTIC_TEST

Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment

Interventions

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Ga-PSMA PET/CT

Patient undergo Ga-PSMA PET/CT prior to the start of the new drug treatment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Géraldine Gebhart, MD

Role: CONTACT

025413095

Loubna Taraji, Ms

Role: CONTACT

025413781

Facility Contacts

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Loubna Taraji Schiltz

Role: primary

Other Identifiers

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IJBMNdTNBC

Identifier Type: -

Identifier Source: org_study_id

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