Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy (TADCOM): a Prospective, Multicenter, Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the use of Carbon Nanoparticle Suspension Injection (CNSI) for targeted axillary dissection (TAD) in women with breast cancer who have undergone neoadjuvant chemotherapy (NAC). This study compares CNSI with traditional clip-based methods to see if CNSI improves the precision of lymph node removal, reduces surgical complications, and enhances clinical outcomes like lymph node retrieval rates and staging accuracy. The trial is a multicenter, randomized controlled study focusing on patients who were initially node-positive but became node-negative after NAC. The study involves three groups. One group receives ultrasound-guided clip insertion into suspicious lymph nodes before NAC, followed by TAD removing sentinel and clipped lymph nodes after NAC. Another group receives ultrasound-guided CNSI injection to mark suspicious lymph nodes before NAC, followed by TAD removing sentinel and carbon-marked lymph nodes. The third group receives CNSI injection around the primary tumor plus an additional clip placement for metastatic lymph nodes before NAC, followed by TAD removing sentinel, carbon-marked, and clipped lymph nodes. These approaches aim to compare the effectiveness and feasibility of CNSI versus traditional clips. Participants will undergo assessments including lymph node retrieval rates, number and concordance of sentinel and marked lymph nodes, surgical complication rates, and long-term outcomes like recurrence and survival, monitored up to five years. Other evaluations include surgical duration, postoperative complications, quality of life measurements, and re-excision surgery rates. The total follow-up includes short-term surgical outcomes and longer-term monitoring to assess the safety and clinical impact of the targeted dissection methods.

Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy