Axillary Surgery in Breast Cancer — Primary Results of the INSEMA Trial

Key Points

• To determine whether omitting surgical axillary staging is noninferior to sentinel-lymph-node biopsy in patients with clinically node-negative early invasive breast cancer.
• Interventional randomized trial (INSEMA, NCT02466737) involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% clinical T1, 79% pathological T1).
• Compared omission of surgical axillary staging against sentinel-lymph-node biopsy with a median follow-up of 6 years.
• Omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up duration of 6 years.