A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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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
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Bone Metastases

Intervention / Treatment
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* Biological: Denosumab
* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zoledronic acid<br> | Drug: Zoledronic Acid<br>* Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC<br>* Other names: Zometa;|
| Experimental: denosumab<br> | Biological: Denosumab<br>* Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | 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. | Up to 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First On-Study Skeletal-Related Event (Superiority) | Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented. | Up to 34 months | 
| Time to First and Subsequent On-Study Skeletal-Related Event | Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events. | Up to 34 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractures, Compressions, Bisphosphonates, Bone metastases, Breast cancer, Skeletal, Radiation, Surgery to Bone