NCT00301886撤回3 期
A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Skeletal-related events (SRE)
研究概览
简要总结
RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of zoledronate vs ibandronate, in terms of preventing the occurrence of skeletal-related events (SRE) (e.g., fracture, spinal cord compression, radiotherapy or surgery for bone symptoms or events, or hypercalcemia ≥ grade 3), in women with stage IV breast cancer and bone metastases.
Secondary
- Compare the change in patient-reported measures of pain and use of analgesics in patients treated with these drugs.
- Compare the time to first clinically apparent SRE in patients treated with these drugs.
- Compare the toxicity of these drugs.
- Compare the changes in performance status and overall survival of patients treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
zoledronate
Experimental
zoledronate
干预措施: zoledronate (Drug)
zoledronate
Experimental
zoledronate
干预措施: quality-of-life assessment (Procedure)
ibandronate
Experimental
ibandronate
干预措施: ibandronate (Drug)
ibandronate
Experimental
ibandronate
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Skeletal-related events (SRE)
次要结局
- Survival and time to first clinically apparent SRE
- Change in patient's rating of worst pain as measured by the Brief Pain Inventory
- Changes in performance status
- Tolerability and toxicity as measured by NCI CTCAE v3.0
研究者
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