A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 752
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
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 is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. 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
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
时间窗: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
次要结局
- Time to Response Per IRRC(based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity)
- Overall Response Rate (ORR) Per IRRC(based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity)
- 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.)
- Overall Survival (OS)(from date of randomization until death)
- Duration of Response Per IRRC(based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity)
- 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.)