Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 196
- 主要终点
- Proportion of Patients With Confirmed Responses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer.
- Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients.
Secondary
* Determine the time to disease progression and survival of patients treated with this regimen.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nab-paclitaxel/Gemcitabine
干预措施: Gemcitabine (Drug)
Nab-paclitaxel/Gemcitabine
干预措施: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Drug)
结局指标
主要结局
Proportion of Patients With Confirmed Responses
时间窗: Two consecutive evaluations at least 6 weeks apart
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
次要结局
- Progression-free Survival(Time from registration to progression or death (up to 5 years))
- Overall Survival(Death or last follow-up (up to 5 years))
- Adverse Event(Every 6 weeks)