68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Area under the ROC curve
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Area under the ROC curve
时间窗: 6 months
To measure the performance of 68Ga-FAPI-46 PET/CT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve).
次要结局
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances(Baseline)
- Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances(Baseline)
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances(Day 168)
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances(5 years)
- Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT(Baseline)
- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances(Baseline)
- Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT(Baseline)