Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
详细描述
Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.
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
- •breast adenocarcinoma
- •prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting
排除标准
- •Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
- •Any prior regimen with capecitabine
研究组 & 干预措施
A
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
干预措施: Capecitabine (Drug)
B
37.5 mg daily, continuous dosing
干预措施: Sunitinib malate (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From time of randomization to every 6 weeks thereafter through 22 months or until death
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
次要结局
- Time to Tumor Progression (TTP)(From time of randomization to every 6 weeks thereafter through 22 months)
- Number of Participants With Overall Response (OR)(From time of randomization to every 6 weeks thereafter through 22 months)
- Duration of Response (DR)(From time of randomization to every 6 weeks thereafter through 22 months or death)
- Time to Tumor Response (TTR)(From time of randomization to every 6 weeks thereafter through 22 months)
- Overall Survival (OS)(From time of randomization until death)
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)(From Day 1 of Cycle 1, then odd numbered cycles thereafter)
- EORTC QLQ Breast Cancer Module (BR23)(From Day 1 of Cycle 1, then odd numbered cycles thereafter)