Actively Recruiting
Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
Led by Institut Curie · Updated on 2026-01-22
450
Participants Needed
13
Research Sites
290 weeks
Total Duration
On this page
Sponsors
I
Institut Curie
Lead Sponsor
N
National Research Agency, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent before joining the study
- Female patients aged 18 years or older
- Diagnosed with non-metastatic triple negative breast cancer (ER & PR <10%, HER2-negative)
- Underwent surgery with curative intent for TNBC between 3 to 9 months before joining
- Started any indicated adjuvant therapy at least 12 weeks before inclusion
- High-risk primary tumor defined by lack of complete response after neoadjuvant chemotherapy, or stage IIB-III, or any loco-regional relapse after prior curative TNBC treatment
- No signs of local or distant relapse
- Performance status less than 2
- Available tumor tissue sample with more than 10% cellularity
- Able to follow study procedures
- Covered by health insurance
You will not qualify if you...
- Any uncontrolled disease or medical condition interfering with trial procedures
- Male participants
- Altered mental status or psychiatric disorder preventing valid consent
- Difficulty undergoing trial procedures due to geographic, social, or psychological reasons
- Person deprived of liberty or under guardianship
- History of other primary cancers except basal cell carcinoma, in situ carcinoma treated curatively, or stage I-II malignancies treated curatively with no active disease in last 5 years
- Clinical or radiological metastatic relapse before molecular relapse detection in randomization step
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Sainte-Catherine Institut du Caner Avignon-Provence
Avignon, France, 84918
Not Yet Recruiting
2
Institut Bergonié
Bordeaux, France, 33000
Not Yet Recruiting
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
4
Centre Leon Bérard
Lyon, France, 69008
Not Yet Recruiting
5
Institut Paoli-Calmettes
Marseille, France, 13009
Not Yet Recruiting
6
Institut du cancer de Montpellier
Montpellier, France, 34298
Not Yet Recruiting
7
CHU Nîmes
Nîmes, France, 30900
Not Yet Recruiting
8
Hôpital Saint-Louis
Paris, France, 75010
Not Yet Recruiting
9
Hôpital Tenon
Paris, France, 75020
Not Yet Recruiting
10
Centre Eugène Marquis
Rennes, France, 35000
Not Yet Recruiting
11
Institut Curie
Saint-Cloud, France, 92340
Actively Recruiting
12
ONCOPOLE Claudius Regaud
Toulouse, France, 31059
Not Yet Recruiting
13
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Not Yet Recruiting
Research Team
A
Anne-Claire COYNE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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