A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 470
- 主要终点
- Time to Progression of Disease or Death
研究概览
简要总结
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.
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
- •women >=18 years of age;
- •>=1 target lesion;
- •locally advanced or metastatic breast cancer;
- •demonstrated resistance to anthracycline;
- •>=2 regimens of chemotherapy for advanced/metastatic disease.
排除标准
- •previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
- •previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
研究组 & 干预措施
1250 mg/m^2 capecitabine + docetaxel
1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
干预措施: capecitabine (Xeloda®) (Drug)
1250 mg/m^2 capecitabine + docetaxel
1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
干预措施: docetaxel (Taxotere®) (Drug)
825 mg/m^2 capecitabine + docetaxel
825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
干预措施: capecitabine (Xeloda®) (Drug)
825 mg/m^2 capecitabine + docetaxel
825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
干预措施: docetaxel (Taxotere®) (Drug)
结局指标
主要结局
Time to Progression of Disease or Death
时间窗: Event driven (after 350 events). Median observation time was approximately 16 months.
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.
次要结局
- Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)(Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.)
- Time to Overall Response(Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.)
- Duration of Overall Response(Until PD or death. Median duration of response was approximately 7 months.)
- Time to Treatment Failure(Until premature withdrawal or end of primary study treatment (up to 16 cycles).)
- Overall Survival(Throughout the study. Median observation time was approximately 16 months.)
- Number of Participants With Adverse Events and Serious Adverse Events(First study drug intake until last study drug intake plus 28 days)