NCT00321464CompletedPhase 3
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 2,049
- Primary Endpoint
- Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Current or prior IV bisphosphonate administration
- •current or prior oral bisphosphonates for bone mets
- •life expectancy of less than 6 months
Arms & Interventions
zoledronic acid
Active Comparator
Intervention: Zoledronic Acid (Drug)
denosumab
Experimental
Intervention: Denosumab (Biological)
Outcomes
Primary Outcomes
Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
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