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

NCT06059469 | Recruiting Phase 2

• 1 other identifier: IJBMNdTNBC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assess PSMA expression in progressive metastatic TNBC patients

  uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.

  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).

  once at baseline prior to the start of the new anti cancer treatment

Study Arms (1)

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

Diagnostic Test: Ga-PSMA PET/CT

Interventions

Ga-PSMA PET/CT DIAGNOSTIC_TEST

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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with ≥ 18 years-old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Géraldine Gebhart, MD

CONTACT

025413095; geraldine.gebhart@hubruxelles.be

Loubna Taraji, Ms

CONTACT

025413781; loubna.taraji@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 28, 2023
• Study Start: May 30, 2022
• Primary Completion: June 2, 2025
• Study Completion: December 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-03

Locations

BE (1)