At a glance
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A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.
In Brief
A Phase 3 clinical trial evaluating Placebo, Denosumab, and 3 other interventions for Breast Cancer. Completed, enrolled 3,420 participants across 46 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.
Study Details
Timeline
Interventions
Administered as a subcutaneous injection
An approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting
5 mg zoledronic acid administered at a constant infusion rate
Standard of care (SoC) as recommended by the treating physician, depending on individual factors such as bone density, lifestyle recommendations by the Investigator such as diet, physical activities and sun exposure, as well as local treatment standards.