Early Detection of Triple Negative Breast Cancer Relapse: a Clinical Utility Phase II Trial
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.
• 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