A Phase IV, Multi-center, Open Label, Single Arm Clinical Trial to Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.
研究概览
简要总结
to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.
详细描述
to evaluate the efficacy and safety of zoledronic acid by measuring changes in bone turnover markers
- the incidence of skeletal-related events
- time to skeletal-related events
- time to bone metastases progression
- overall survival
- the incidence of each adverse event including osteonecrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging)
- •Men or women aged ≥ 18 years
- •WHO (ECOG) performance status 0-2
- •Women of child-bearing potential must be using a reliable and appropriate method of contraception
- •Urine sample taken and sent to the central laboratory for baseline Ntx analysis
- •Written informed consent.
排除标准
- •Bisphosphonate treatment within the 4 weeks prior to planned first study treatment
- •Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute
- •Poor venous access
- •Metabolic bone disease
- •Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements
- •Estimated life expectancy of < 6 months
- •Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry
- •Wide field (hemi-body) radiotherapy within the 3 months prior to study entry
- •Concomitant medication with drugs known to affect bone metabolism
- •Pregnancy or breast-feeding
- •Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ)
- •Recent (within 4 weeks of study entry*) or planned dental or jaw surgery
研究组 & 干预措施
Zoledronic acid
Patients with advanced breast cancer with radiographic confirmation of bone metastases. This arm will be receiving zoledronic acid administration. The primary endpoint is to find the correlation between bone turnover markers and the frequency of skeletal-related-events for one year. Skeletal related events are defined as pathologic fractures, the need for radiation therapy, orthopaedic surgery, hypercalcemia of malignancy and spinal cord compression. A total of 237 patients will be included.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Urinary NTX and serum osteocalcin will be assessed at baseline, 3, 6, 9, and 12 months and when unexpected skeletal related events is detected.
时间窗: one year
次要结局
未报告次要终点