Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

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.