A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical/pathological response
研究概览
简要总结
The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
- •Age 18-70
- •No evidence of distant metastasis
- •No previous therapy
- •Normal hematologic function
- •No abnormality of renal or liver function
- •Written informed consent
排除标准
- •With allergic constitution or possible allergic reflection to drugs to be used in this study
- •Any concurrent uncontrolled medical or psychiatric disorder
- •History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
- •Being pregnant or nursing
研究组 & 干预措施
Chemo plus Endostar
Docetaxel, epirubicin and cyclophosphamide plus endostar
干预措施: docetaxel, epirubicin and cyclophosphamide plus endostar (Drug)
Chemo only
docetaxel, epirubicin and cyclophosphamide
干预措施: docetaxel, epirubicin and cyclophosphamide (Drug)
结局指标
主要结局
Clinical/pathological response
时间窗: 48 months
The clincial response will be evaluated according to RECIST criteria.
次要结局
- PFS(5 years)
研究者
Yunjiang Liu
M.D, Chief Physician of Breast Cancer Dept, Vice-President of Hebei Medical University Fourth Hospital
Hebei Medical University Fourth Hospital