NCT00321464已完成3 期
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 2,049
- 主要终点
- Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
研究概览
简要总结
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adults with histologically or cytologically confirmed breast adenocarcinoma
- •radiographic evidence of at least one bone mets
- •Easter Cooperative Oncology Group status of 0, 1 or 2;
- •adequate organ function
排除标准
- •Current or prior IV bisphosphonate administration
- •current or prior oral bisphosphonates for bone mets
- •life expectancy of less than 6 months
研究组 & 干预措施
zoledronic acid
Active Comparator
干预措施: Zoledronic Acid (Drug)
denosumab
Experimental
干预措施: Denosumab (Biological)
结局指标
主要结局
Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
时间窗: Up to 34 months
Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.
次要结局
- Time to First On-Study Skeletal-Related Event (Superiority)(Up to 34 months)
- Time to First and Subsequent On-Study Skeletal-Related Event(Up to 34 months)
研究者
相似试验
已完成
3 期
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple MyelomaHematologic MalignanciesOncologyBone MetastasesMultiple Myeloma Bone LesionsCancerMultiple MyelomaNCT01345019Amgen1,718
已完成
3 期
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.Bone MetastasesNCT00330759Amgen1,779
已完成
3 期
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate CancerBone MetastasesNCT00321620Amgen1,904
已完成
3 期
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With GlucocorticoidsOsteoporosisNCT00799266Novartis Pharmaceuticals34
已完成
2 期
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral DensityPostmenopausal OsteoporosisNCT00293813Amgen247