A Randomized, Double-blinded, Multicenter Study of Denosumab Compared With Zoledronic acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer
Phase 3
- Conditions
- Advanced breast cancer with bone metastases
- Registration Number
- JPRN-jRCT2080220875
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 1960
Inclusion Criteria
Adult with histologically or cytologically confirmed breast adenocarcinoma, and radiographic evidence of at least 1 bone metastasis
Exclusion Criteria
-Current or prior IV bisphosphonate administration
-Current of prior oral bisphosphonates for bone mets
-Life expectancy of less than 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to the first on-study SRE<br>The Cox model is used for the analyses of time to the first on-study SRE
- Secondary Outcome Measures
Name Time Method Time to the first-and-subsequent on-study SRE<br>The Andersen and Gill approach is used for the analyses of time to the first-and-subsequent on-study SRE