Actively Recruiting
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Led by Institut Curie · Updated on 2025-12-22
60
Participants Needed
6
Research Sites
424 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
CONDITIONS
Official Title
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Previously untreated, non-metastatic, centrally confirmed triple-negative breast cancer
- Neoadjuvant chemotherapy plus pembrolizumab recommended as standard care
- Measurable tumor targets according to RECIST/PERCIST criteria
- No distant metastasis based on staging 18F-FDG PET/CT
- Available tumor tissue for analysis
- Signed written informed consent provided
- Ability to comply with study protocol requirements
- Covered by a health insurance system
You will not qualify if you...
- Pregnant or lactating women
- Prior treatment with anti-PD(L)1 immunotherapy
- Contraindications to chemo-immunotherapy standard of care as assessed by investigator
- Altered mental status or psychiatric disorders preventing valid informed consent
- Difficulty undergoing trial procedures due to geographic, social, or psychological reasons
- Person deprived of liberty or under guardianship
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hôpital Privé d'Antony
Antony, France, 92160
Actively Recruiting
2
Institut Curie -site Paris
Paris, France, 75005
Actively Recruiting
3
GH Diaconesses Croix Saint-Simon
Paris, France, 75020
Actively Recruiting
4
Institut Curie -site St Cloud
Saint-Cloud, France, 92210
Actively Recruiting
5
HIA Begin
Saint-Mandé, France, 94160
Actively Recruiting
6
Hôpital FOCH
Suresnes, France, 92150
Actively Recruiting
Research Team
S
Sandra Nespoulous
CONTACT
M
Marie-Emmanuelle LEGRIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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