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RECRUITING
NCT06225505
NA

Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

Sponsor: Institut Curie

View on ClinicalTrials.gov

Summary

CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse. The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \~4 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.

Official title: Early Detection of Triple Negative Breast Cancer Relapse: a Clinical Utility Phase II Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2026-01-05

Completion Date

2031-08-03

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

ctDNA monitoring

For each patient included, a ctDNA detection assay will be performed in blood samples every 4 months, while extra-plasma will be banked. ctDNA results will be available with a turnaround time of less than 3 weeks. When negative, ctDNA detection results will not be disclosed to patients nor clinicians.

DIAGNOSTIC_TEST

68Ga-FAPI-46-PET-CT

). To locate metastatic deposits, patients will be offered to undergo a whole-body imaging with 18F-FDG PET-CT and 68Ga-FAPI-46-PET-CT, in addition to any other workup considered as relevant by their treating physician.

Locations (13)

Sainte-Catherine Institut du Caner Avignon-Provence

Avignon, France

Institut Bergonié

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Leon Bérard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Institut du cancer de Montpellier

Montpellier, France

CHU Nîmes

Nîmes, France

Hôpital Saint-Louis

Paris, France

Hôpital Tenon

Paris, France

Centre Eugène Marquis

Rennes, France

Institut Curie

Saint-Cloud, France

ONCOPOLE Claudius Regaud

Toulouse, France

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, France