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

Официальное название

68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer

Обзор

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.

Подробное описание

Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.

Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity.

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Area under the ROC curve [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances [Срок оценки: Baseline]
• Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances [Срок оценки: Baseline]
• Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances [Срок оценки: Day 168]
• Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances [Срок оценки: 5 years]
• Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 6 центров

• Hôpital Privé d'Antony — Antony
• Institut Curie -site Paris — Paris
• GH Diaconesses Croix Saint-Simon — Paris
• Institut Curie -site St Cloud — Saint-Cloud
• HIA Begin — Saint-Mandé
• Hôpital FOCH — Suresnes

Идентификаторы

NCT: NCT06349512 · IC 2022-07 · 2023-507860-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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