Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy

What this Trial Is About

Researchers are studying breast cancer patients who had positive axillary lymph nodes at diagnosis but show no remaining cancer in those nodes after neoadjuvant systemic therapy (NST). This phase II trial evaluates if axillary lymph node dissection (ALND) can be safely avoided in these patients when confirmed by a special biopsy called Stained region Lymph Node Biopsy (SrLNB). The goal is to observe local-regional recurrence and long-term survival over three years in 92 patients who meet this criteria. Participants will first receive injection of carbon nanoparticles to mark positive lymph nodes before NST. After NST, these marked nodes are biopsied with SrLNB. If the biopsy confirms no cancer, patients will not undergo ALND but will receive regional lymph node radiotherapy (RNI) including the axilla, at a dose of 50 Gy over 25 sessions. In addition, patients will have adjuvant chemotherapy, targeted therapy, and hormone therapy after surgery. Throughout the study, patients will be monitored for up to three years after breast surgery for invasive disease-free survival. Researchers will assess local and regional cancer recurrence and long-term outcomes. Evaluations include pathology, clinical exams, imaging, and follow-up treatments. Safety and effectiveness of omitting ALND in this group will be tracked carefully during this period.

Omission of ALND in Breast Cancer Patients With Axillary pCR