A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pathological complete response rate
研究概览
简要总结
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18≤aged<70
- •pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+）
- •Immunohistochemical（IHC） positive for 3+ or FISH（+）
- •clear hormone receptor（HR） status
- •Eastern cooperative oncology group(ECOG)=0/1
- •pathologic grading of Miller and Payne
- •screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ULM,Aspartate transaminase (AST)/ALT≤2.5×ULM,platelet≥80000/mm3，serum creatinine≤1.5×ULM
- •no pregnant or nursing
- •signed Informed consent forms
排除标准
- •prior exposure to any treatments for breast cancer
- •inflammatory/Bilateral/IV stage breast cancer
- •poor physical condition
- •pregnant or nursing
- •Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure>180mmHg/diastolic pressure>100mmHg））
- •any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer
- •Allergic to chemotherapy drugs
研究组 & 干预措施
A group
docetaxel+carboplatin+trastuzumab
干预措施: Docetaxel (Drug)
A group
docetaxel+carboplatin+trastuzumab
干预措施: Trastuzumab (Drug)
A group
docetaxel+carboplatin+trastuzumab
干预措施: Carboplatin (Drug)
B group
Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
干预措施: Epirubicin (Drug)
B group
Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
干预措施: Docetaxel (Drug)
B group
Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
干预措施: Trastuzumab (Drug)
结局指标
主要结局
pathological complete response rate
时间窗: up to one year
次要结局
- Number of Adverse Event(up to one year)
- clinical response rate(up to one year)