TheranosticTrials.org

Clinical Trial · NCT06225505

Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

Overview

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.

Sponsor

Institut Curie

Phase

N/A

Contacts

Anne-Claire COYNE (CONTACT)

drci.promotion@curie.fr

0147111515

François-Clément BIDARD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06225505

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FAPI-46

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC
  • Available FFPE tumor block with \> 10% cellularity or 11 tumor sections with \>10% cellularity
  • Patient able to comply with protocol requirements
  • 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.
  • No sign of local or distant relapse, as per investigator assessment
  • Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR
  • 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 covered by a health insurance
  • High-risk primary tumor, defined as:
  • Performance status \< 2
  • 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,

Exclusion

  • History of another primary malignancy except for the following :
  • Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years
  • Basal cell carcinoma or any in situ carcinoma treated with curative intent
  • 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
  • For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.
  • Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons
  • Person deprived of liberty or under guardianship