NCT00087958已完成2 期
Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine
适应症
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
- 168
- 试验地点
- 16
- 主要终点
- Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
研究概览
简要总结
The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.
详细描述
All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once every three weeks. This drug prevents tumor cells from dividing, so they may stop growing or die.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible for this trial you must:
- •Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
- •Have received previous treatment with anthracyclines (e.g. doxorubicin [Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [Taxotere]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments are no longer of benefit to you.
- •Be at least 18 years of age
- •Not be taking other treatments for your cancer at the time you enter the trial.
- •Not be pregnant
- •Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (lab tests, CT scans).
排除标准
- •None listed here. Can be discussed with your doctor.
结局指标
主要结局
Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
次要结局
- Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks
- Time to tumor response and duration of response.
- Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.
研究者
研究点 (16)
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