Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
Early Detection of Triple Negative Breast Cancer Relapse: a Clinical Utility Phase II Trial
Institut Curie
450 participants
Jan 5, 2026
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria13
- Patients must have signed a written informed consent before inclusion
- Patients must be female ≥ 18 years old
- Patients diagnosed with a non-metastatic TNBC (ER \& PR \<10%, HER2- per ASCO/CAP guidelines). Patients must have been previously evaluated by a 18F-FDG PET-CT or a bone scintigraphy combined with a thorax, abdomen and pelvis CT scan with contrast
- Patients who have undergone surgery with curative intent for their non-metastatic TNBC. Surgery must have been performed between 3 to 9 months before inclusion. Patients must have initiated their adjuvant therapy, whenever indicated, since at least 12 weeks. For patients receiving an experimental adjuvant treatment in a clinical trial, any intervention planned as part of this trial must be completed before inclusion.
- High-risk primary tumor, defined as:
- Lack of pathological complete response after neoadjuvant chemotherapy (RCB I, II or III; RCB I being capped to a maximum of 30% of included patients) OR, in the absence of neoadjuvant chemotherapy,
- Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR
- Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC
- No sign of local or distant relapse, as per investigator assessment
- Performance status \< 2
- Available FFPE tumor block with \> 10% cellularity or 11 tumor sections with \>10% cellularity
- Patient able to comply with protocol requirements
- Patients covered by a health insurance
Exclusion Criteria9
- Any uncontrolled disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, interferes with the trial procedures
- Male participants
- Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
- Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons
- Person deprived of liberty or under guardianship
- History of another primary malignancy except for the following :
- Basal cell carcinoma or any in situ carcinoma treated with curative intent
- Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years
- For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.
Interventions
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.
). 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)
View Full Details on ClinicalTrials.gov
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NCT06225505