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.

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ClinicalTrials.gov IDNCT06349512
PhaseNA
Enrollment60
SponsorInstitut Curie
Age18 Years and older
SexFEMALE
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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

Primary outcomes

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

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.