FAP-IT68Ga-FAPI-46 PET/CT for predicting histological response to neoadjuvant chemo-immunotherapy in triple-negative breast cancer - IC 2022-07

Institut Curie0 个研究点目标入组 300 人开始时间: 2023年12月11日最近更新: 2024年7月22日

适应症

试验速览

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•Female with age = 18 years, Patients with previously untreated, non-metastatic, centrally confirmed TNBC (stage T1c N1-2 or T2-4 N0-2 per AJCC) 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

•Patients with prior anti-PD(L)1 immunotherapy, Pregnant and lactating women, 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, Patients who are not affiliated to a social security system, or who are deprived of liberty, or under guardianship, Person deprived of liberty or under guardianship

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