Axillary Sentinel Lymph Node Biopsy After Chemotherapy in Patients with Initial cN1 Breast Cancer A Real-World Study Evaluating Best Techniques and Long-Term Safety

What this Trial Is About

Researchers are evaluating the best technical approach and long-term tumor safety of sentinel lymph node biopsy SLNB in patients with initial cN1 breast cancer who have undergone neoadjuvant chemotherapy NAC and have downgraded to clinical axillary node-negative status ycN0. Although SLNB is recommended by guidelines, the optimal technique and long-term safety data are still unclear, prompting this real-world study to explore these aspects further. The primary focus is on axillary recurrence-free survival, alongside other important outcomes related to lymph node recurrence, disease-free survival, overall survival, lymphedema incidence, and quality of life. This prospective, multicenter, single-arm study involves patients receiving SLNB after completing NAC and before breast surgery. If the frozen pathology of sentinel lymph nodes SLNs is negative, no axillary lymph node dissection ALND is performed. If SLNs are positive or the frozen pathology is falsely negative, ALND is recommended, with completion within 12 weeks after SLNB surgery if needed. The study aims to evaluate this optimized pathway and its outcomes in a real-world clinical setting. Participants will be monitored over five years after surgery to assess axillary recurrence-free survival and secondary outcomes such as regional lymph node recurrence, disease-free survival, overall survival, and postoperative upper limb lymphedema. Quality of life will also be evaluated using the EORTC-QLQ-C30 V3 scale. The study involves regular follow-up and assessments to track these outcomes and understand the long-term safety and effectiveness of the SLNB approach in this patient group.

Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer