TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes

Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated. The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.

NCT Number	NCT05462457
Lead Sponsor	Kliniken Essen-Mitte
Conditions	Breast Cancer, Node-positive Breast Cancer
Enrollment	150 participants
Start Date	2022-03-07
Primary Completion	2027-03 (estimated)
Study Completion	2032-03 (estimated)
Updated on ClinicalTrials.gov	2023-02-15