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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00321464
First received: May 2, 2006
Last updated: July 1, 2010
Last verified: July 2010
History of Changes

May 2, 2006
July 1, 2010
April 2006
July 2009   (final data collection date for primary outcome measure)
Time to first on-study Skeletal Related Event (SRE) [ Time Frame: Study is event driven. May take longer than 33 months of study duration to observe 745 first on-study SREs in study population. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00321464 on ClinicalTrials.gov Archive Site
Time to first and subsequent on-study SREs [ Time Frame: Study is event driven. May take longer than 33 months of study duration to observe 745 first on-study SREs in study population. ] [ Designated as safety issue: Yes ]
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 in Subjects With Advanced Breast Cancer
  • Biological: Denosumab
    120 mg SC Q4W
  • Drug: Zoledronic Acid
    4mg IV Zoledronic Acid over 15 minutes
    Other Name: Zometa
  • Active Comparator: 980 subjects with advanced breast cancer: zoledronic acid
    Active Comparator IV over 15 minutes + placebo SC Q4W
    Intervention: Drug: Zoledronic Acid
  • Experimental: 980 subjects with advanced breast cancer: denosumab
    Experimental SC + placebo IV over 15 minutes Q4W
    Intervention: Biological: Denosumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2049
July 2011
July 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
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Latvia,   Lithuania,   Mexico,   Netherlands,   Panama,   Peru,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT00321464
20050136
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Daiichi Sankyo Inc.
Study Director: MD Amgen
Amgen
July 2010

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