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

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ClinicalTrials.gov Identifier: NCT00321464
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : March 10, 2014
Last Update Posted : March 8, 2017
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Metastases Biological: Denosumab Drug: Zoledronic Acid Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2049 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : April 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: zoledronic acid Drug: Zoledronic Acid
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
Other Name: Zometa

Experimental: denosumab Biological: Denosumab
Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: 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.

  2. Time to First and Subsequent On-Study Skeletal-Related Event [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321464


Sponsors and Collaborators
Amgen
Daiichi Sankyo, Inc.
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00321464     History of Changes
Other Study ID Numbers: 20050136
First Posted: May 3, 2006    Key Record Dates
Results First Posted: March 10, 2014
Last Update Posted: March 8, 2017
Last Verified: January 2017

Keywords provided by Amgen:
Fractures
Compressions
Bisphosphonates
Bone metastases
Breast cancer
Skeletal
Radiation
Surgery to Bone

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Denosumab
Bone Marrow Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs