NCT00286247已完成2 期
Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer
Introgen Therapeutics2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年2月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.
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
- •Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer
- •Male or female
- •18 years or older
- •Adequate bone marrow, liver, and kidney function
排除标准
- 未提供
研究者
研究点 (2)
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