biostudies-literatureUnknown12(1)Reimer TThe sub-study of the INSEMA trial (randomization-2) compares completion axillary lymph node dissection (cALND) with sentinel lymph node biopsy (SLNB) alone in cN0 patients with T1/T2 invasive breast cancer and one to three sentinel node macrometastases undergoing upfront breast-conserving surgery. The key secondary objective is to assess whether the SLNB-alone arm is non-inferior to cALND in terms of invasive disease-free survival (iDFS). Finally, 485 patients were recruited, and 386 patients (cALND: N = 169, SLNB alone: N = 217) were included in the per-protocol set. The median follow-up is 74.2 months. The 5-year iDFS analysis in the per-protocol set demonstrates a non-significant difference between study arms, with a hazard ratio (HR) of 1.69 (95% CI: 0.98-2.94) for SLNB alone compared NPJ breast cancer19https://www.ebi.ac.uk/biostudies/studies/S-EPMC12855813biostudies-literatureAxillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial.PMC12855813Marme FKrug DReimer TKuehn TGerber BLoibl SKnauer MRuth SDenkert CHoltschmidt JGolatta MStahl NVeselinovic KAtaseven BStachs ANekljudova VHeil JTrapp EReitsamer RBekes IStrittmatter HJPolata SHildebrandt GThill MMueller TZahm DMfalseAxillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial.The sub-study of the INSEMA trial (randomization-2) compares completion axillary lymph node dissection (cALND) with sentinel lymph node biopsy (SLNB) alone in cN0 patients with T1/T2 invasive breast cancer and one to three sentinel node macrometastases undergoing upfront breast-conserving surgery. The key secondary objective is to assess whether the SLNB-alone arm is non-inferior to cALND in terms of invasive disease-free survival (iDFS). Finally, 485 patients were recruited, and 386 patients (cALND: N = 169, SLNB alone: N = 217) were included in the per-protocol set. The median follow-up is 74.2 months. The 5-year iDFS analysis in the per-protocol set demonstrates a non-significant difference between study arms, with a hazard ratio (HR) of 1.69 (95% CI: 0.98-2.94) for SLNB alone compared 2026-01-01T00:00:00Z2026 Jan2026-06-14T05:33:10.913Z2026-06-14T03:09:25.566ZS-EPMC128558134159310810.1038/s41523-026-00902-7