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Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
Sponsor: Institut Curie
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
Conditions
Interventions
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.
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