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

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

Not applicable Interventional Institut Curie · NCT06225505

This study tests whether regular ctDNA blood checks combined with 68Ga‑FAPI‑46 and 18F‑FDG PET‑CT scans can find relapse earlier in people who finished treatment for high‑risk, non‑metastatic triple‑negative breast cancer.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexFemale
SponsorInstitut Curie Academic / other
Drugs / interventionschemotherapy
Locations13 sites (Avignon and 12 other locations)
Trial IDNCT06225505 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (female, ≥18 years) with non‑metastatic, high‑risk triple‑negative breast cancer who completed curative surgery 3–9 months earlier and have started any indicated adjuvant therapy at least 12 weeks before enrollment are ideal candidates.

Not a fit: Patients who are already metastatic at enrollment, those at low risk of relapse, or patients whose tumors do not shed detectable ctDNA are unlikely to benefit from this monitoring approach.

Why it matters

Potential benefit: If successful, this approach could enable earlier, imaging‑confirmed detection of metastatic relapse and more timely treatment decisions.

How similar studies have performed: ctDNA minimal‑residual‑disease detection has predicted relapse earlier than imaging in several cancer studies, but using ctDNA to trigger 68Ga‑FAPI‑46 PET‑CT is a novel approach that remains unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.
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 this trial is running

Avignon and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast CancerTriple negative breast cancer68Ga-FAPI-46ctDNA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.