Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,404
- 试验地点
- 79
- 主要终点
- Frequency and timing of skeletal-related events (SREs)
研究概览
简要总结
RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer.
PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy, in terms of reducing frequency and timing of skeletal-related events (SREs), of ibandronate vs zoledronate in patients with newly diagnosed bone metastases secondary to breast cancer.
Secondary
- Compare the median time to first SRE in patients treated with these regimens.
- Compare the percentage of patients experiencing a SRE after treatment with these regimens.
- Compare the number of occult vertebral fractures present in patients at the end of treatment with these regimens.
- Compare the pain and analgesic scores and quality of life of patients treated with these regimens.
- Compare the number of patients developing renal dysfunction or hypocalcemia during the study period.
- Compare the number of patients developing osteonecrosis of the jaw during study treatment and follow-up.
- Compare the overall survival of these patients at 96 weeks and at 5 years.
- Compare the health-resource usage of patients treated with these regimens.
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
- All
- 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
Ibandronic Acid
50mg tablet once daily over 96 weeks
干预措施: ibandronate sodium (Drug)
Zoledronic Acid
4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
干预措施: zoledronic acid (Drug)
Zoledronic Acid
4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
干预措施: Zolendronic Acid (Drug)
结局指标
主要结局
Frequency and timing of skeletal-related events (SREs)
时间窗: 96 weeks
次要结局
- Toxicity(96 weeks)
- Survival(5 years)
- Quality of life(96 weeks)
- Time to first SREs(96 Weeks)
- Proportion of patients with SREs(96 Weeks)
- Pain and analgesic score(96 weeks)
- Health resource usage and serum bone marker levels(96 weeks)