Status of the international prospective multicenter AXSANA study evaluating different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655, AGO-B-053)

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Objective: The AXSANA study investigates the optimal surgical axillary staging procedure for breast cancer patients with initially node-positive breast cancer who convert to a clinically node-negative status (ycN0) after neoadjuvant chemotherapy (NACT). Materials/Methods: AXSANA is an ongoing, prospective, international, non-interventional registry study initiated by the European Breast Cancer Research Association of Surgical Trialists (EUBREAST e.V.). Breast cancer patients (cT1-4c, cM0) with initially clinically node-positive tumors who receive at least 4 cycles of NACT are included. Patients are treated according to the institutional and national standards applicable at the study site. Primary endpoints are invasive disease-free survival, axillary recurrence rate, and health-related quality of life. Results: By February 1, 2026, 7074 patients had been enrolled at 290 study sites in 27 countries. The conversion rate to ycN0 was 68.1%. The following axillary staging procedures were performed: axillary lymph node dissection (ALND) 36.6%, targeted axillary dissection (TAD) 47.4%, sentinel lymph node biopsy (SLNB) 12.9%, target lymph node biopsy (TLNB) 0.6%, and other 2.5%. In patients with a high initial axillary tumor burden (>3 suspicious lymph nodes), ALND as initial staging was performed in 66.0% and less radical procedures (TAD/SLNB/TLNB) in 30.8% of participants; in patients with 1-3 suspicious lymph nodes, ALND was performed in 28.5% of cases versus 69.1% less radical staging procedures.

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