A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
详细描述
On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced breast cancer.
- •Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
- •ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
排除标准
- •No prior treatment with cytotoxics in the advanced disease setting.
- •HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
- •Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.
研究组 & 干预措施
A
干预措施: Sunitinib (Drug)
A
干预措施: paclitaxel (Drug)
B
干预措施: bevacizumab (Drug)
B
干预措施: paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death
Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4
次要结局
- Number of Participants With Objective Response(From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months)
- Duration of Response (DR)(From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause)
- Overall Survival (OS)(From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.)
- Percentage of Participants Surviving at 1 and 2 Years(Year 1, Year 2)
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)(Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months)
- EORTC QLQ Breast Cancer Module (BR23)(Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months)
- Euro Quality of Life-5 Dimension (EQ-5D)(Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months)
- EQ - Visual Analog Scale (EQ-VAS)(Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months)
- Biomarkers(Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1)