Prospective Clinical Trial on Expanding the Eligibility Criteria for Targeted Axillary Dissection after Neoadjuvant Systemic Therapy in Breast Cancers with Advanced Nodal Disease.

BACKGROUND: Targeted axillary dissection (TAD) is an established axillary restaging approach in breast cancer after neoadjuvant chemotherapy (NAC), but evidence to date has focused largely on clinical N1 disease with limited nodal involvement. For higher nodal burden patients, axillary dissection (AD) is still frequently performed despite high axillary pathologic complete response (pCR) rates. We hypothesized that TAD is noninferior to AD for nodal staging in patients with advanced nodal disease. PATIENTS AND METHODS: Patients with higher nodal burden breast cancer planned for NAC followed by curative surgery were included. Higher nodal burden was defined as > 3 metastatic nodes up to clinical N3 stage. Patients underwent TAD followed by AD during the same operation. The primary outcome was the false negative rate (FNR) of TAD. Secondary outcomes included clipped node detection rate, concordance between clipped and sentinel nodes, and axillary pCR rates. RESULTS: A total of 65 patients were prospectively recruited from February 2023 to October 2025; 10 withdrew, leaving 55 for analysis. The technical success rate of TAD was 96%, with clipped node detection rate of 100% and sentinel node detection rate of 96%. The clipped node was identified as an additional sentinel node in 68%. Axillary pCR occurred in 49%. In non-pCR patients, TAD demonstrated a FNR of 0%. CONCLUSIONS: In clinical N1 (> 3 nodes), N2, and N3 patients, a 0% FNR suggests TAD is highly accurate for detecting residual axillary disease in the setting of higher nodal burden. These results support expanding TAD eligibility in appropriately selected patients to potentially reduce AD and its morbidities.