Phase 3
Completed N=2,046
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
Source: ClinicalTrials.gov NCT00321464 ↗Enrolled (actual)
2,046
Serious AEs
45.5%
Results posted
Mar 2014
Primary outcomePrimary: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) — 372; 315 Participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) |
372; 315 | <0.0001 sig |
| SECONDARY Time to First On-Study Skeletal-Related Event (Superiority) |
372; 315 | 0.010 sig |
| SECONDARY Time to First and Subsequent On-Study Skeletal-Related Event |
608; 474 | 0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00321464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.