Status:
COMPLETED
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
Lead Sponsor:
Amgen
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- Current or prior IV bisphosphonate administration
- current or prior oral bisphosphonates for bone mets
- life expectancy of less than 6 months
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2012
Estimated Enrollment :
2049 Patients enrolled
Trial Details
Trial ID
NCT00321464
Start Date
April 1 2006
End Date
April 4 2012
Last Update
November 8 2022
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