NCT00584766已完成2 期
Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Quality of maximal response; time to initial disease progression; and overall survival
研究概览
简要总结
To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast carcinoma at first clinical evidence of metastatic disease
- •must have measurable disease by physical exam, x-ray, or scan
- •Age < or equal to 55
- •performance status 0-2
排除标准
- •can't have had more than one prior chemotherapy regimen
- •can't have had concurrent hormonal therapy
- •no brain metastases
- •no previous pelvic radiation
- •no history of another malignancy
研究组 & 干预措施
1
Experimental
干预措施: High-dose chemotherapy (Procedure)
结局指标
主要结局
Quality of maximal response; time to initial disease progression; and overall survival
时间窗: undetermined
次要结局
- to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer(undetermined)
研究者
研究点 (1)
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