Early detection of triple negative breast cancer relapse (CUPCAKE)

Trial details

Who runs it

Institut Curie

Trial code

EU 2022-501562-22-01

Record updated

2026. július 3.

Original description

To evaluate the efficacy of ctDNA-based surveillance strategy, in terms of risk of early deathRead full original descriptionShow less

"CUPCAKE": Early detection of triple negative breast cancer relapse: a clinical utility trial

To evaluate the efficacy of ctDNA-based surveillance strategy, in terms of risk of early death

Inclusion: Patients must have signed a written informed consent before inclusion; Patients covered by a health insurance; 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 24 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: a.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, b.Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR c. 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.

Exclusion: History of another primary malignancy except for the following : a. Basal cell carcinoma or any in situ carcinoma treated with curative intent b. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years 6.7. For step #2 (randomization after ctDNA detection): clinical/radiological; Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent; 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 who have difficulty undergoing trial procedures for geographic, social or psychological reasons; Person deprived of liberty or under guardianship; For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.

EU CTIS 2022-501562-22-01