RecruitingNot ApplicableNCT06349512
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
Sponsor
Institut Curie
Enrollment
60 participants
Start Date
Oct 14, 2024
Study Type
INTERVENTIONAL
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 patients with early-stage high-risk TNBC.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria8
- 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 Criteria6
- 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
Interventions
PROCEDURE68Ga-FAPI-46 PET/CT imaging
The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06349512