Status:
RECRUITING
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Lead Sponsor:
Institut Curie
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 patien...
Detailed Description
Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients ...
Eligibility Criteria
Inclusion
- Female with age ≥ 18 years,
- Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
- Patients with measurable targets according to RECIST/PERCIST criteria,
- Patients without distant metastasis based on staging 18F-FDG PET/CT,
- Patients with tumor tissue available,
- Patients who provided a signed written informed consent,
- Patient ability to comply with protocol requirements,
- Patients covered by a health insurance system.
Exclusion
- Pregnant and lactating women,
- Patients with prior anti-PD(L)1 immunotherapy,
- Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
- 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
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2032
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06349512
Start Date
October 14 2024
End Date
November 30 2032
Last Update
December 22 2025
Active Locations (6)
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1
Hôpital Privé d'Antony
Antony, France, 92160
2
Institut Curie -site Paris
Paris, France, 75005
3
GH Diaconesses Croix Saint-Simon
Paris, France, 75020
4
Institut Curie -site St Cloud
Saint-Cloud, France, 92210