Recruiting
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
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.
ClinicalTrials.gov IDNCT06349512
PhaseNA
Enrollment60
SponsorInstitut Curie
Age18 Years and older
SexFEMALE
Conditions studied
Triple Negative Breast Cancer
About this study
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.
Interventions
- Procedure: 68Ga-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.
Primary outcomes
- Area under the ROC curve (6 months)
Eligibility information
Inclusion Criteria:
1. Female with age ≥ 18 years,
2. 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,
3. Patients with measurable targets according to RECIST/PERCIST criteria,
4. Patients without distant metastasis based on staging 18F-FDG PET/CT,
5. Patients with tumor tissue available,
6. Patients who provided a signed written informed consent,
7. Patient ability to comply with protocol requirements,
8. Patients covered by a health insurance system.
Exclusion Criteria:
1. Pregnant and lactating women,
2. Patients with prior anti-PD(L)1 immunotherapy,
3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
6. Person deprived of liberty or under guardianship
Study locations
- Hôpital Privé d'Antony, Antony, 92160 France
- Institut Curie -site Paris, Paris, 75005 France
- GH Diaconesses Croix Saint-Simon, Paris, 75020 France
- Institut Curie -site St Cloud, Saint-Cloud, 92210 France
- HIA Begin, Saint-Mandé, 94160 France
- Hôpital FOCH, Suresnes, 92150 France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-04.