Jana de Boniface, Tove Filtenborg Tvedskov, Lisa Rydén, Robert Szulkin, Toralf Reimer, Thorsten Kühn, Michalis Kontos, Oreste D Gentilini, Roger Olofsson Bagge, Malin Sund, Dan Lundstedt, Matilda Appelgren, Johan Ahlgren, Sophie Norenstedt, Fuat Celebioglu, Helena Sackey, Inge Scheel Andersen, Ute Hoyer, Per F Nyman, Eva Vikhe Patil, Elinore Wieslander, Henrik Dahl Nissen, Sara Alkner, Yvette Andersson, Birgitte V Offersen, Leif Bergkvist, Jan Frisell, Peer Christiansen
BACKGROUND: Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups. METHODS: We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, ≤20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only)...
April 4, 2024: New England Journal of Medicine