A Randomized Phase III 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-line Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Locally Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 96
- 主要终点
- Overall Survival (PP Population)
研究概览
简要总结
First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.
详细描述
Arm A:
Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks
Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks
Arm B:
Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks
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
结局指标
主要结局
Overall Survival (PP Population)
时间窗: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.
Overall Survival (ITT Population)
时间窗: Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years
Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250.
次要结局
- Observation Time (ITT Population)(Up to approximately 6 years)
- Best Overall Response (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Best Overall Response (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Unconfirmed Best Overall Response (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Unconfirmed Best Overall Response (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Objective Response Rate and Disease Control Rate (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Progression Free Survival (ITT Population)(Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.)
- Progression Free Survival (PP Population)(Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.)
- Time to Treatment Failure (ITT Population)(From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years)
- Objective Response Rate and Disease Control Rate (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Time to Treatment Failure (PP Population)(From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years)
- Time to Response (ITT Population)(Time from randomization until occurrence of response, assessed up 1.7 years)
- Unconfirmed Objective Response Rate and Disease Control Rate (PP Population)(Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.)
- Time to Response (PP Population)(Time from randomization until occurrence of response, assessed up 1.7 years)
- Duration of Response (ITT Population)(Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.)
- Duration of Response (PP Population)(Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.)