Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
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…
Conditions studied
Triple Negative Breast Cancer
About this study
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.
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.
Primary outcomes
- Overall survival (36 months)
Eligibility information
Study locations
- Sainte-Catherine Institut du Cancer Avignon-Provence, Avignon, 84918 France
- Institut Bergonié, Bordeaux, 33000 France
- Centre Jean Perrin, Clermont-Ferrand, 63011 France
- Centre Leon Bérard, Lyon, 69008 France
- Institut Paoli-Calmettes, Marseille, 13009 France
- Institut du cancer de Montpellier, Montpellier, 34298 France
- CHU Nîmes, Nîmes, 30900 France
- Hôpital Saint-Louis, Paris, 75010 France
- Hôpital Tenon, Paris, 75020 France
- Centre Eugène Marquis, Rennes, 35000 France
Showing 10 of 13 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.