NCT00295867已完成2 期
Pilot Study to Evaluate the Effect of Zoledronic Acid (Zometa) on Occult Malignant Bone Marrow Cells in Patients With High Risk Early Stage Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Response of Bone Marrow Micrometastases
研究概览
简要总结
RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast cancer.
PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow micrometastases in women with stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response of bone marrow micrometastases, as measured by immunocytochemistry/flow cytometry (IC/FC), during and after 2 years of treatment with zoledronate in women with stage I-III breast cancer.
Secondary
- Evaluate the effects of zoledronate on the bone osteoclast activation marker, n-telopeptide, in these patients.
- Evaluate the incidence of distant recurrences in high-risk women with early-stage breast cancer and bone marrow micrometastases who receive adjuvant zoledronate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Zoledronic Acid
Experimental
Patients women with early stage breast cancer and evidence of occult malignant cells in bone marrow aspirates following adjuvant chemotherapy will receive zoledronic acid (Zometa) 4mg, given intravenously over 15 minutes, once a month for two years.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Response of Bone Marrow Micrometastases
时间窗: up to 2 years
Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months
次要结局
- Change in N-telopeptide Level(up to 2 years)
- Number of Patients With Incidences of Distant Recurrence(up to 5 years post initiation of treatment)
研究者
研究点 (1)
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