NCT00393939已完成3 期
A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
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
- 594
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.
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 cancer with evidence of unresectable locally recurrent, or metastatic disease
- •Her-2 negative tumors
排除标准
- •Patients for whom docetaxel is contraindicated
- •Clinical presentation of inflammatory carcinoma with no other measurable disease
研究组 & 干预措施
A
Experimental
干预措施: Sunitinib malate (Drug)
B
Active Comparator
干预措施: Taxotere (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline up to Month 33
PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.
次要结局
- Percentage of Participants With Objective Response(Baseline up to Month 33)
- Overall Survival (OS)(Baseline to date of death from any cause (up to Month 33))
- Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score(Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33))
- Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score(Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33))
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score(Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33))
- Duration of Response (DR)(Baseline up to Month 33)
研究者
研究点 (1)
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