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

Phase 3

Completed

• Conditions: Bone Metastases
• Interventions: Biological: Denosumab; Drug: Zoledronic Acid

• Registration Number: NCT00321464
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-01
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-03
• Primary Completion: 2009-07-20
• Disposition First Submitted: 2010-06-29
• Disposition First Submitted QC: 2010-06-29
• Disposition First Posted: 2010-07-01
• Results First Submitted: 2010-12-10
• Study Completion: 2012-04-04
• Results First Submitted QC: 2014-01-23
• Results First Posted: 2014-03-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2049

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
denosumab	Denosumab	-
zoledronic acid	Zoledronic Acid	-

Primary Outcome Measures

Name	Time	Method
Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)	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 Outcome Measures

Name	Time	Method
Time to First On-Study Skeletal-Related Event (Superiority)	Up to 34 months	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.
Time to First and Subsequent On-Study Skeletal-Related Event	Up to 34 months	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.