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 investigating whether axillary lymph node dissection (ALND) can be safely avoided in female breast cancer patients who show no remaining cancer in their axillary lymph nodes after receiving neoadjuvant systemic therapy (NST). This prospective, single-arm phase II trial focuses on patients initially diagnosed with biopsy-proven positive axillary lymph nodes that convert to negative status confirmed by a stained region lymph node biopsy (SrLNB). The study aims to evaluate the impact on invasive disease-free survival and local-regional recurrence over three years of follow-up. Participants will undergo SrLNB following NST, where carbon nanoparticles are injected to stain lymph nodes, which are then biopsied to confirm response. Those confirmed to have axillary pathological complete response will omit ALND and instead receive complete regional node irradiation (RNI) including the axilla at a dose of 50 Gy over 25 sessions. Additionally, patients will receive adjuvant chemotherapy, targeted therapy, and endocrine therapy after surgery. The trial includes a detailed radiation protocol covering the supraclavicular region and entire axillary lymphatic drainage areas. During the study, participants will be closely monitored for up to three years with assessments focusing on invasive disease-free survival, local-regional recurrence, breast cancer-related lymphedema, quality of life, and patient-reported arm morbidity. Follow-up visits will include physical exams, imaging, and questionnaires to track health outcomes and side effects. This comprehensive monitoring will help determine the safety and long-term effects of omitting ALND in this patient group.

Omission of ALND in Breast Cancer Patients With Axillary pCR