Clinical Trial

AXillary Surgery After NeoAdjuvant Treatment

Study acronym: AXSANA
Recruiting
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Summary
The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ → ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-05-01; most recent amendment 2025-02-27.
Trial Details
NCT Number NCT04373655
Lead Sponsor European Breast Cancer Research Association of Surgical Trialists
Collaborators: AWOgyn, AGO-B, North Eastern German Society of Gynaecological Oncology, GBG Forschungs GmbH, Claudia von Schilling Foundation for Breast Cancer Research, Ehmann-Stiftung Savognin
Conditions Breast Cancer
Enrollment 3,000 participants
Start Date 2020-04-28
Primary Completion 2030-04 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2025-03-03