Amgen
S.C. Linn (for BOOG)
Amgen: A. Aarts en H. Denecker BOOG: A.E. van Leeuwen-Stok
Amgen
Amgen NL
Subjects will be randomized in a 1:1 ratio to receive denosumab 120 mg or matching placebo subcutaneously (SC) every 4 weeks (Q4W; ± 7 days) for 6 months followed by denosumab 120 mg or matching placebo SC every 3 months (Q3M; i.e. every 12 weeks ± 14 days) for 4½ years (approximately 54 months), for a total treatment duration of 5 years (approximately 60 months).
Primary: Tocompare the treatment effect of denosumab with that of placebo on prolonging bone metastasis-free survival (BMFS) in subjects with early-stage breast cancer at high risk of disease recurrence Secondary Objectives: To compare the treatment effect of denosumab with that of placebo on: Disease-free survival (DFS) Overall survival (OS) Distant recurrence-free survival (DRFS) Safety Objectives: Toassess the safety and tolerability of denosumab compared with placebo.
Primary:
BMFS (determined by the time from randomization to the first observation of bone metastasis or death from any cause)
Secondary:
Adjuvant treatment for women with early-stage breast cancer at high risk of disease recurrence receiving standard of care adjuvant/neoadjuvant cancer therapy Inclusion Criteria: Histologically confirmed, AJCC stage II or III breast cancer High risk of breast cancer recurrence, defined as documented evidence of one or more of the following criteria: o Biopsy evidence of breast cancer in regional LN (node positive disease) o Tumor size > 5 cm (T3) or locally advanced disease (T4) Documented pathological evaluation of the breast cancer for hormone receptor (ER and PR) status and HER-2 status Subjects must be receiving or be scheduled to receive standard of care adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy Exclusion Criteria: Prior or current evidence of metastatic disease History of breast cancer prior to current diagnosis (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] Osteoporosis requiring treatment Active oral, dental or jaw condition Non-healed dental or oral surgery Use of oral bisphosphonates within the past year Prior or current IV bisphosphonate administration Subject is pregnant or breast feeding
