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Clinical Trials/NCT00321464
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

Amgen0 sites2,049 target enrollmentStarted: April 1, 2006Last updated:
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

Sponsor
Amgen
Sponsor Class
Industry
Responsible Party
Sponsor

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