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临床试验/NCT00321464
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

Amgen0 个研究点目标入组 2,049 人开始时间: 2006年4月1日最近更新:
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

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

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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