Why carry out this study?

Although denosumab treatment reduces skeletal-related event (SRE) risk and delays the time to first SRE in patients with solid metastatic tumors, the benefits of denosumab to bone health have not been established in patients with early-stage breast cancer at high risk of disease recurrence.

Besides evaluating bone metastasis-free survival (BMFS), we further investigated the potential benefits of denosumab treatment by assessing the prespecified bone endpoints and the associated subgroup analysis in patients with high-risk early breast cancer receiving denosumab versus placebo.

What was learned from the study?

The hazard ratios of the prespecified exploratory bone endpoints mostly favored denosumab over placebo, suggesting a clinically meaningful effect of denosumab in these patients.

This study demonstrates that denosumab improves bone-related outcomes for women with high-risk early breast cancer.