A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,611
- 主要终点
- Disease Free Survival [Number of Events]
研究概览
简要总结
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •female patients 18-70 years of age;
- •adenocarcinoma of the breast;
- •previous invasive breast cancer if diagnosed >5 years before entering study;
- •no evidence of metastatic disease.
排除标准
- •history of severe hypersensitivity reaction to Taxotere;
- •previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
- •treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
研究组 & 干预措施
1
干预措施: capecitabine [Xeloda] (Drug)
1
干预措施: Taxotere (Drug)
2
干预措施: Taxotere (Drug)
结局指标
主要结局
Disease Free Survival [Number of Events]
时间窗: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Disease Free Survival [Time to Event]
时间窗: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
次要结局
- Overall Survival [Number of Events](Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.)
- Overall Survival [Time to Event](Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.)
- Breast Cancer Free Survival [Number of Events](Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .)
- Breast Cancer Free Survival [Time to Event](Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.)
- Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events](Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.)
- Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event(Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.)
- Disease Free Survival Including Any New Cancer as Event [Number of Events](Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.)
- Disease Free Survival Including Any New Cancer as Event [Time to Event](Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.)