A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Annual Overall Skeletal Morbidity Rate (SMR)
研究概览
简要总结
The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
Every 3 months
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every three months. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized patients will receive a maximum of 4 infusions in this group.
干预措施: Zoledronic acid (Drug)
Every 4 weeks
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every 4 weeks. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Patients randomized to this group will receive up to 12 infusions.
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Annual Overall Skeletal Morbidity Rate (SMR)
时间窗: 12 months
The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy. SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.
次要结局
- Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)(12 month)
- Median Time to First Skeletal Related Event(s) (SRE)(12 month)
- Annual Incidence of Any Skeletal Related Events (SREs)(12 months)
- Percentage of Participants Skeletal Related Event (SRE) Free(12 months)
- Use Of Analgesic Medications According to the Analgesic Score Scale(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire(At Baseline, Month 3, Month 6, Month 9 and Month 12)