Early detection of relapse in triple‑negative breast cancer using blood DNA and advanced PET imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CUPCAKE uses a Trials‑within‑Cohorts design to follow high‑risk, non‑metastatic TNBC patients with ctDNA monitoring every ~4 months for up to 24 months, with ctDNA results available within three weeks. If ctDNA is detected, patients are randomized 1:1 between continued blinded monitoring and an arm where the ctDNA result is disclosed and patients are offered whole‑body 18F‑FDG PET‑CT plus 68Ga‑FAPI‑46 PET‑CT and any additional workup deemed relevant. No systemic therapy will be started solely on the basis of a positive ctDNA result; treatment requires imaging or clinical confirmation of relapse. Extra plasma is banked for future research and timing of radiologic relapse and performance status at relapse are recorded as secondary outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must have signed a written informed consent before inclusion
2. Patients must be female ≥ 18 years old
3. 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
4. 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.
5. High-risk primary tumor, defined as:

   1. 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,
   2. Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR
   3. Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC
6. No sign of local or distant relapse, as per investigator assessment
7. Performance status \< 2
8. Available FFPE tumor block with \> 10% cellularity or 11 tumor sections with \>10% cellularity
9. Patient able to comply with protocol requirements
10. Patients covered by a health insurance

Exclusion Criteria:

1. 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
2. Male participants
3. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
4. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons
5. Person deprived of liberty or under guardianship
6. History of another primary malignancy except for the following :

   1. Basal cell carcinoma or any in situ carcinoma treated with curative intent
   2. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years
7. For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.

Where it's running

• Institut Curie
  Saint-Cloud, France Recruiting
• Sainte-Catherine Institut du Cancer Avignon-Provence
  Avignon, France Not yet recruiting
• Institut Bergonié
  Bordeaux, France Not yet recruiting
• Centre Jean Perrin
  Clermont-Ferrand, France Not yet recruiting
• Centre Leon Bérard
  Lyon, France Not yet recruiting
• Institut Paoli-Calmettes
  Marseille, France Not yet recruiting

Study contacts

• Principal investigator: François-Clément BIDARD — Institut Curie
• Study coordinator: Anne-Claire COYNE
• Email: drci.promotion@curie.fr
• Phone: 0147111515

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.