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Life sciences · Observational Study
ClinicalTrials.gov · September 15, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT04373655). This is a study registration, not published results. Lead sponsor: European Breast Cancer Research Association of Surgical Trialists. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 3000 participants (ESTIMATED). Conditions: Breast Cancer. Primary outcome measures: Invasive disease-free survival (iDFS) , 5 years; Axillary recurrence rate , 3 years; Health-related quality of life , 5 years; Arm morbidity , 5 years. Brief 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.