Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

Recruiting now · Not applicable

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT06225505

Run by

Institut Curie

People needed

450

Starts

2026-01-05

Expected to finish

2031-08-03

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 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:
• 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

You may not qualify if…

• 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.

Where it is running

• Institut Curie — Saint-Cloud, France (enrolling)
• Institut Bergonié — Bordeaux, France
• Centre Jean Perrin — Clermont-Ferrand, France
• Centre Leon Bérard — Lyon, France
• Institut Paoli-Calmettes — Marseille, France
• Institut du cancer de Montpellier — Montpellier, France
• CHU Nîmes — Nîmes, France
• Hôpital Saint-Louis — Paris, France
• Hôpital Tenon — Paris, France
• Centre Eugène Marquis — Rennes, France
• ONCOPOLE Claudius Regaud — Toulouse, France
• Sainte-Catherine Institut du Cancer Avignon-Provence — Avignon, France
• Institut de cancérologie de Lorraine — Vandœuvre-lès-Nancy, France

Full record on ClinicalTrials.gov

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