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NCT00321464 Clinical Trial

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

Bone Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00321464
Other study ID # 20050136
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 1, 2006
Est. completion date April 4, 2012

Study information
Verified date November 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2049
Est. completion date April 4, 2012
Est. primary completion date July 20, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Amgen Daiichi Sankyo, Inc.

References & Publications (3)

Cleeland CS, Body JJ, Stopeck A, von Moos R, Fallowfield L, Mathias SD, Patrick DL, Clemons M, Tonkin K, Masuda N, Lipton A, de Boer R, Salvagni S, Oliveira CT, Qian Y, Jiang Q, Dansey R, Braun A, Chung K. Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid. Cancer. 2013 Feb 15;119(4):832-8. doi: 10.1002/cncr.27789. Epub 2012 Sep 5. — View Citation

Martin M, Bell R, Bourgeois H, Brufsky A, Diel I, Eniu A, Fallowfield L, Fujiwara Y, Jassem J, Paterson AH, Ritchie D, Steger GG, Stopeck A, Vogel C, Fan M, Jiang Q, Chung K, Dansey R, Braun A. Bone-related complications and quality of life in advanced breast cancer: results from a randomized phase III trial of denosumab versus zoledronic acid. Clin Cancer Res. 2012 Sep 1;18(17):4841-9. Epub 2012 Aug 14. — View Citation

Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010 Dec 10;28(35):5132-9. doi: 10.1200/JCO.2010.29.7101. Epub 2010 Nov 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) 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. Up to 34 months
Secondary Time to First On-Study Skeletal-Related Event (Superiority) 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. Up to 34 months
Secondary Time to First and Subsequent On-Study Skeletal-Related Event 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. Up to 34 months
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