NCT07032220

Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. This was done to investigate the detection rate of carbon nanoparticle-labeled lymph nodes and to assess the stability and safety of carbon nanoparticles. Additionally, the dye single tracer method was employed for sentinel lymph node biopsy to evaluate the false-negative rate of TAD. This is an open-label, single-arm, multi-center prospective clinical trial. The primary objectives of this study are to evaluate the accuracy, feasibility, and safety of this method, thereby improving the quality of life and reducing postoperative complications for breast cancer patients while ensuring treatment efficacy.

Conditions

• Breast Cancer Surgery
• Neoadjuvant Therapy
• Sentinel Lymph Node Biopsy (SLNB)

Interventions

Type	Name	Description
DRUG	carbon suspension	Before primary systemic therapy, a core needle biopsy or fine-needle aspiration of the most suspicious axillary lymph node was performed.22 Sterile black carbon suspension (0.5 mL: 25 mg, Chongqing LUMMY Pharmaceutical Co) was injected in the cortex of the metastatic node under ultrasound guidance using a 25G needle by a trained ultrasonographer at the time of biopsy or during a separate session. The injection volume was recorded and varied depending on node size and operator. The trained ultrasonographer had more than 5 years of puncture experience. Of note, for the patients with multiple abnormal nodes or N3 disease under ultrasound at diagnosis, only the pathologically-proven lymph node is marked with carbon suspension.

Timeline

• Start date: 2024-12-09
• Primary completion: 2027-01-31
• Completion: 2028-01-31
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: China