A Randomized Phase II Trial of Paclitaxel and Bevacizumab Versus Gemcitabine, Paclitaxel, and Bevacizumab as First Line Treatment for Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This study will compare the cancer response to both treatments for locally advanced 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
- •Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
- •Must be able to measure the disease by specific medical parameters
- •May have received breast cancer treatment in the early stage of the disease
- •May be restricted in physically strenuous activity but able to carry out light work.
- •Must have adequate organ function as seen in blood test results.
- •Cancer that has spread to the brain.
- •Unstable heart problems
- •Unstable high blood pressure.
- •Breast cancer treatment after the disease has considered to spread to other areas or organs.
- •Unable to agree with the requirements of the study
排除标准
- 未提供
研究组 & 干预措施
paclitaxel plus bevacizumab (PB)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
干预措施: paclitaxel (Drug)
paclitaxel plus bevacizumab (PB)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
干预措施: bevacizumab (Drug)
paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
干预措施: gemcitabine (Drug)
paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
干预措施: paclitaxel (Drug)
paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
干预措施: bevacizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).
次要结局
- Progression-free Survival (PFS)(baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated))
- Overall Survival(baseline to death from any cause (up to 35 months))
- Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))
- Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))
- Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))
- Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))
- Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))
- Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))
- Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy(Baseline through 30 days post therapy follow-up (up to 35 months))