Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

Although there is no doubt that the presence of lymph node metastases worsens prognosis of a patient, unambiguous evidence to support lymph node dissection is still lacking. For many solid tumors, the role of lymph node dissection is yet controversial, and may depend on the tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast cancer is now considered as staging procedure that does not seem to influence breast cancer mortality. Women with breast cancer have benefitted greatly from a series of carefully performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA is to show that less axillary surgery is better, in that oncological outcomes are the same and less surgical intervention will result in fewer surgical complications.

NCT Number	NCT02466737
Lead Sponsor	University of Rostock Collaborators: German Cancer Aid, GBG Forschungs GmbH
Conditions	Breast Cancer
Enrollment	5,505 participants
Start Date	2015-09
Primary Completion	2024-08-30 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-01