A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,221
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
干预措施: Ixabepilone + Capecitabine (Drug)
B
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: from date of randomization until death
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
次要结局
- Progression-Free Survival (PFS)(every 6 weeks (± 3 days) from randomization while on treatment until documented progression)
- Duration of Response(every 6 weeks (± 3 days) from randomization while on treatment until documented progression)
- Response Rate (RR)(every 6 weeks (± 3 days) from randomization while on treatment until documented progression)
- Time to Response(every 6 weeks (± 3 days) from randomization while on treatment until documented progression)
- Treatment-Related Safety Summary(safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.)
- Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)(Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment)