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

RecruitingNAAges 18 Years - 85 YearsFemaleSecond Affiliated Hospital, Zhejiang University, …
NCT04744506 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Female patients aged 18 to 85 years are eligible. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1. 4. Clinical re-staging must indicate an axillary node status of ycN0 following NAC. 5. Participants must provide written informed consent to partake in the trial, acknowledging understanding and agreement to the procedures and risks involved. Exclusion Criteria: 1. Patients with metastatic breast cancer (Stage IV). 2. Diagnosed with inflammatory breast cancer or bilateral breast cancer. 3. History of axillary surgical procedures. 4. Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up. 5. Known allergy to carbon nanoparticles or presence of severe comorbid conditions or other serious underlying medical issues. 6. Current or prior participation in another clinical trial that could interfere with the outcome of this study or affect the safety and well-being of the participants.
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What it tests

  • Tissue Marker Clip
  • Carbon Nanoparticle Suspension Injection
  • Carbon Nanoparticle Suspension Injection
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Where

1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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