NCT05480189尚未招募不适用
Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- SREs
研究概览
简要总结
non-intervention、real world study； Effect of timing and regular treatment of zoledronic acid on the incidence of SREs in breast cancer patients
详细描述
(1) Main Purpose: To observe the clinical efficacy of zoledronic acid regularly in the prevention of SREs in breast cancer patients with bone metastasis (2) Secondary Objectives:
- To observe whether zoledronic acid prolonged the time of first SREs in patients with bone metastasis;
- The clinical efficacy and influencing factors of zoledronic acid in different subgroups were observed by subgroup analysis of population baseline, clinical characteristics (such as different types of breast cancer), past history and complications.
- To observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in Chinese breast cancer patients with first bone metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥18 years
- •Histologically confirmed breast cancer
- •Initial diagnosis of bone metastasis by MRI or CT and treatment with zoledronic acid
- •Serum creatinine ≤265mol/L or 3.0mg/dl
- •CrCl ≥ 30 ml/min
- •Serum Ca2+ concentration 2.0-3.0 mmonl/L 7.ECOG score ≤2 Voluntary research, informed consent
排除标准
- •Pregnant and lactating women
- •Severe liver insufficiency (ALT and/or AST higher than 3 times the upper limit of normal)
- •Patients with osteoarthritis or other bone related diseases need bone targeted therapy
- •Patients with uncontrolled dental problems or planned jaw surgery
结局指标
主要结局
SREs
时间窗: 3 years
skeletal-related events (SREs) including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and the need for radiotherapy and/or surgery to bone
次要结局
- time to first on-study SRE(3 years)
研究者
Wang Xiaojia
MD
Zhejiang Cancer Hospital
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