NCT02553850已完成不适用
A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 主要终点
- Beta C-terminal telopeptide (B-CTx) level
研究概览
简要总结
This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
- •Adult patients greater than (>) 18 years of age
- •Histologically confirmed breast cancer
- •Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
- •Life expectancy >6 months
- •No previous bisphosphonate therapy
- •Patients signed written informed consent form before study start
排除标准
- •All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
- •Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
- •Hypersensitivity to bisphosphonates
结局指标
主要结局
Beta C-terminal telopeptide (B-CTx) level
时间窗: 12 months
Treatment response rate
时间窗: 12 months
次要结局
- Number of patients who died due to progression of breast cancer(12 months)
- Safety: Incidence of adverse events(12 months)
研究者
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