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68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)

RecruitingNAAges 18 Years - anyFemaleInstitut Curie
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • 68Ga-FAPI-46 PET/CT imaging
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Where

6 sites
Hôpital Privé d'Antony
Antony, France
Institut Curie -site Paris
Paris, France
GH Diaconesses Croix Saint-Simon
Paris, France
Institut Curie -site St Cloud
Saint-Cloud, France
HIA Begin
Saint-Mandé, France
Hôpital FOCH
Suresnes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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