An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.
详细描述
Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged : 20~70 years
- •WHO (ECOG) performance status 0-2
- •Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- •patients had previously not received chemotherapy of recurrent or metastatic lesion.
- •Have given written informed consent and are available for prolonged follow-up
排除标准
- •Patients with previous chemotherapy for recurrent breast cancer
- •Breast cancer recurrence within 12 months after taxane treatment
- •Her-2/neu expression breast cancer
- •Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- •Brain metastasis
- •uncontrolled infection, medically uncontrollable heart disease
- •other serious medical illness or prior malignancies
- •Pregnant or lactating women were excluded.
研究组 & 干预措施
docetaxel/ oxaliplatin
All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
干预措施: docetaxel/ oxaliplatin (Drug)
结局指标
主要结局
overall response rate
时间窗: 2 years
次要结局
- progression free survival(2 years)
- toxicity(2 years)
- quality of life(2 years)