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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of denosumab in treating bone metastases from advanced breast cancer?
How does denosumab compare to zoledronic acid in managing skeletal-related events in breast cancer patients?
Which biomarkers correlate with response to RANKL inhibition in breast cancer bone metastases trials?
What are the adverse event profiles and management strategies for denosumab versus zoledronic acid in oncology?
Are there combination therapies involving denosumab or zoledronic acid improving outcomes for RANKL-positive breast cancer bone metastases?