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Clinical Trial Summary

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.


Clinical Trial Description

Eligible participants were randomized in a 1:1 ratio to receive denosumab 120 mg or placebo subcutaneously (SC) for up to 5 years. Randomization was stratified based on: 1. Breast cancer therapy/lymph node (LN) status: neoadjuvant therapy/any LN status versus adjuvant therapy/LN negative (based on axillary LN dissection, or based on sentinel node status) versus adjuvant therapy/LN positive 2. Hormone receptor (estrogen receptor [ER]/progesterone receptor [PR]) status: ER and/or PR positive versus ER and PR negative 3. Human epidermal growth factor receptor 2 (HER-2) status: HER-2 positive versus HER-2 negative 4. Age: < 50 years versus ≥ 50 years 5. Geographic Region: Japan versus Other regions. The primary analysis was conducted after all enrolled participants had the opportunity to complete 5 years of treatment from study day 1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01077154
Study type Interventional
Source Amgen
Contact
Status Terminated
Phase Phase 3
Start date June 2, 2010
Completion date March 26, 2018

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