This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC), compared to traditional clip-based methods. By leveraging CNSI's enhanced visibility and stability, the study aims to improve the precision of lymph node removal, reduce surgical complications, and potentially transform clinical practices. Conducted across multiple centers, this randomized controlled trial focuses on clinical outcomes such as lymph node retrieval rates and the accuracy of surgical staging, aiming to establish a safer, more effective approach to managing axillary lymph nodes in breast cancer surgery.
Female patients aged 18 to 85 years are eligible.
Participants must have a histologically confirmed diagnosis of breast cancer, classified as cT1-4N1-2aM0 according to the 8th edition of the AJCC (American Joint Committee on Cancer) TNM classification system.
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
Clinical re-staging must indicate an axillary node status of ycN0 following NAC.
Patients with metastatic breast cancer (Stage IV).
Diagnosed with inflammatory breast cancer or bilateral breast cancer.
History of axillary surgical procedures.
Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Zhejiang Provincial Natural Science Foundation of China
Collaborator