NCT00435409已完成3 期
A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
- •Previous treatment with an anthracycline and a taxane in any setting
- •Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months
排除标准
- •History of inflammatory carcinoma if there is no other measurable disease
- •More than 2 chemotherapy agents in the advanced disease setting
- •Brain metastases
研究组 & 干预措施
A
Experimental
干预措施: Sunitinib + Capecitabine (Drug)
B
Active Comparator
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline until disease progression (up to 3 years from first dose)
Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.
次要结局
- Percentage of Participants With Objective Response (OR)(Baseline until response or disease progression (up to 3 years from first dose))
- Duration of Response (DR)(Baseline until response or disease progression (up to 3 years from first dose))
- Overall Survival (OS)(Baseline until death or up to 3 years from first dose)
- Percent Chance of Participant Survival(Year 1, Year 2, Year 3)
- Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)(Day 1 of each treatment cycle (up to 3 years or end of treatment))
- Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)(Day 1 of each treatment cycle (up to 3 years or end of treatment))
- Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)(Day 1 of each treatment cycle (up to 3 years or end of treatment))
研究者
研究点 (1)
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