An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Progression-free Survival
研究概览
简要总结
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female patients, ≥ 18 years of age.
- •Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
- •HER-2 negative disease.
- •Candidates for chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
排除标准
- •Previous chemotherapy for metastatic or locally advanced breast cancer.
- •Previous radiotherapy for treatment of metastatic breast cancer.
- •Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.
- •Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).
研究组 & 干预措施
Bevacizumab + paclitaxel + gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Bevacizumab (Drug)
Bevacizumab + paclitaxel + gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Paclitaxel (Drug)
Bevacizumab + paclitaxel + gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Baseline to the end of the study (up to 2 years 10 months)
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
次要结局
- Percentage of Participants With an Objective Response(Baseline to the end of the study (up to 2 years 10 months))
- Duration of the Objective Response(Baseline to the end of the study (up to 2 years 10 months))
- Overall Survival(Baseline to the end of the study (up to 2 years 10 months))