The Role of Multimodal Imaging and Circulating Biomarkers in Predicting the Response of Neoadjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- pathological complete response (pCR)
研究概览
简要总结
The BINC-B trial is a diagnostic and interventional study in which various function imaging methods as Magnetic Resonance Imaging (PWI, DWI and DCE-MRI) and will be compared with common imaging methods (mammography and/or ultrasound) to investigate if an early response to a combined neoadjuvant chemotherapy in operable or potentially operable breast cancer. For breast cancer patients with positive HER-2, additional Herceptin could improve the response further. In this study the efficacy of combined neoadjuvant therapy with or without Herceptin should be evaluated and the role in predicting the tumor response with different imaging should be estimated.
详细描述
Firstly, the investigators aim to show that the results of functional imaging including dynamic enhanced, diffuse weighted, and perfusion MR imaging biomarkers as well the ultrasonic outcome could be used to predict the response to the neoadjuvant chemotherapy for operable and potentially operable breast cancer (luminal B, HER-2 positive and triple negative).
Secondly, the investigators will study the role of peripheral blood biomarker including circulating tumor DNA (ctDNA), circulating endothelial cells (CECs) and subsets, myeloid-derived suppressor cells (MDSCs), and lymph cell subsets and their combinations could predict the response of the tumor measured with imaging.
Thirdly, the investigators will establish a mode with these multiple imaging and serum biomarker panel as well as their changes during the treatment course establish to predict the response to neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Neoadjuvant chemotherapy
Epirubicin 100mg/m2 and cyclophosphamine 600mg/m2 for four cycles followed by paclitaxol 175mg/m2 for four cycles with (for patients with positive HER-2) or without Trastuzumab (loading dose of 6 mg/kg followed by 4 mg/kg every 2 weeks for four cycles), each cycle is 14 days.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
pathological complete response (pCR)
时间窗: from the first day of the the first cycle (each cycle is 14 days) of neoadjuvant chemotherapy to the date that breast and axillary sugery will be performed
Rate of pathological complete response (pCR) following neoadjuvant therapy and to determine efficacy of neoadjuvant therapy in primary breast cancer using pCR (According to National Surgical Adjuvant Breast and Bowel Project guideline)
次要结局
- Response rate(from the first day of the the first cycle (each cycle is 14 days) of neoadjuvant chemotherapy to the date that breast and axillary sugery will be performed)
- Disease free survival(from the first day of the the first cycle of neoadjuvant chemotherapy (each cycle is 14 days) to the date of first documented progression or date of death from breast cancer, whichever came first, assessed up to 60 months)
- Overall survival(from the first day of the the first cycle (each cycle is 14 days) of neoadjuvant chemotherapy to the date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Wenyong Tan
Director
Shenzhen People's Hospital