NCT00584428已完成不适用
High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur.
研究概览
简要总结
To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.
详细描述
There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of breast cancer
- •Age 18-70
- •Breast cancer at first clinical evidence of metastatic disease
- •Must have objectively measurable or evaluable disease or be in complete remission
排除标准
- •Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
- •CNS involvement
结局指标
主要结局
Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur.
时间窗: Undetermined
次要结局
- No secondary outcomes(Undetermined)
研究者
研究点 (2)
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