NCT00387907已完成2 期
Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Tumor response measured
研究概览
简要总结
The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.
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
- •Diagnosis of breast cancer
- •Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
- •No more than one prior treatment for advanced disease
- •Her2 positive status
- •Adequate liver and kidney function
- •No remaining severe harmful effects to prior treatments
排除标准
- •Certain heart condition
- •Pregnant Women
- •History of another cancer except some skin cancers and cervical cancer
- •Taking other treatments for your cancer at the time you enter the trial
研究组 & 干预措施
Larotaxel + Trastuzumab
Experimental
干预措施: larotaxel (XRP9881) (Drug)
Larotaxel + Trastuzumab
Experimental
干预措施: trastuzumab (Drug)
结局指标
主要结局
Tumor response measured
时间窗: every 2 cycles during treatment phase
次要结局
- Progression Free Survival and Overall Survival(measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months)
研究者
研究点 (1)
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