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Study Complete
Sponsor ID
20050136

A study comparing denosumab vs. zoledronic acid for the treatment of bone metastases in breast cancer subjects.

Sponsor ID
20050136
Clinicaltrials.gov ID
NCT00321464
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
2049
Additional Study Details

Protocol Summary

Primary Outcome Measures

Time to First On-Study Skeletal Related Event (SRE) (non-inferiority)

Timeframe: Up to 34 months

Secondary Outcome Measures

Time to First On-Study Skeletal-Related Event (superiority)

Timeframe: Up to 34 months

Time to First and Subsequent On-Study Skeletal-Related Event

Timeframe: Up to 34 months

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Advanced/Metastatic Cancer
    • Sex
    All
    Trial Dates
    Apr 2006 - Jul 2009
    Inclusion and Exclusion 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