A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Median Progression-Free Survival
研究概览
简要总结
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.
详细描述
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
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 120 Years（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
Abraxane, Avastin and Gemcitabine
Each treatment cycle is 28 days. Participants will be treated until disease progression:
- Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
- Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
- Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
干预措施: Avastin (Drug)
Abraxane, Avastin and Gemcitabine
Each treatment cycle is 28 days. Participants will be treated until disease progression:
- Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
- Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
- Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
干预措施: Gemcitabine (Drug)
Abraxane, Avastin and Gemcitabine
Each treatment cycle is 28 days. Participants will be treated until disease progression:
- Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
- Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
- Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
干预措施: Abraxane (Drug)
结局指标
主要结局
Median Progression-Free Survival
时间窗: Up to 24 months
Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
次要结局
- Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment(Baseline, over the course of Treatment, about 1 year)
- Relationship Between SPARC Expression and Response to Protocol Therapy.(Baseline, over the course of treatment, about 1 year)
- Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants(After two cycles, about 60 days)
- Rate of Toxicity in Study Participants(Over the course of study treatment.)