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

• Status: Completed
• Trial end date: 2012-04-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

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