A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 主要终点
- ORR,TTP,TTF and 2 year PFS
研究概览
简要总结
Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.
The second objective:Assess the safety and QOL.
详细描述
The study main inclusion criteria are:1.age≥18,KPS>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pathologic diagnosis of breast cancer
- •at least 1 measurable lesion as defined by modified RECIST criteria
- •screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
- •signed ICF
- •for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.
排除标准
- •More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
- •prior exposure to 5-Fluorouracil continuous infusion.
- •prior exposure docetaxol for metastatic disease
- •Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
研究组 & 干预措施
A
Arm A is "docetaxol+capecitabine" chemotherapy
干预措施: docetaxol, cisplatin, capecitabine (Drug)
B
Arm B is "docetaxol+cisplatin" chemotherapy
干预措施: docetaxol, cisplatin, capecitabine (Drug)
结局指标
主要结局
ORR,TTP,TTF and 2 year PFS
时间窗: 2008-2010
次要结局
- safety and QOL(2008-2010)