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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00321464
First received: May 2, 2006
Last updated: March 25, 2014
Last verified: March 2014

May 2, 2006
March 25, 2014
April 2006
March 2009   (final data collection date for primary outcome measure)
Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) [ Time Frame: Up to 34 months ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00321464 on ClinicalTrials.gov Archive Site
  • Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: Up to 34 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 34 months ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Bone Metastases
  • Biological: Denosumab
    Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes
  • Drug: Zoledronic Acid
    Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
    Other Name: Zometa
  • Active Comparator: zoledronic acid
    Intervention: Drug: Zoledronic Acid
  • Experimental: denosumab
    Intervention: Biological: Denosumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2049
April 2012
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00321464
20050136
Yes
Amgen
Amgen
Daiichi Sankyo Inc.
Study Director: MD Amgen
Amgen
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP