A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study
研究概览
简要总结
The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
干预措施: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg (Drug)
Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
干预措施: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg (Drug)
Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
干预措施: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg (Drug)
结局指标
主要结局
Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study
时间窗: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression
Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.
次要结局
- Percentage of Participants With Progression-free Survival at Week 24(Date of randomization to Week 24)
- Median Progression-free Survival (PFS)(Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months))
- Median Time to Response(Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks))
- Median Duration of Response(Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks))
- Percentage of Participants Surviving at 1 Year(Date first participant enrolled to 1 year)
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs(At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug)
- Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade(At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle)
- Number of Participants With Abnormalities in Liver Function by Worst CTC Grade(At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle)
- Number of Participants With Abnormalities in Renal Function by Worst CTC Grade(At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle)