Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Adjuvant denosumab falls short in early-stage breast cancer

Key clinical point: Adjuvant denosumab did not improve bone metastasis–free survival and related outcomes in women with early-stage, high-risk breast cancer.

Major finding: At 5-year follow-up, no significant difference in bone metastasis–free survival was observed between the denosumab and placebo treatment arms (median survival not reached in either arm; P = .70).

Study details: A phase 3 trial of 4,509 patients with early-stage, high-risk breast cancer.

Disclosures: Amgen funded the study. The authors reported financial affiliations with AbbVie, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Covance, Lilly, Medivation, Merck Serono, Merck Sharp and Dohme, Novartis, Pfizer, and several others.


Coleman R et al. Lancet Oncol. 2019 Dec 2. doi: 10.1016/S1470-2045(19)30687-4.