Actively Recruiting
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-12
126
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
Z
Zhejiang Provincial Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 85 years
- Histologically confirmed breast cancer classified as cT1-4N1-2aM0 per AJCC 8th edition
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Clinical re-staging showing axillary node-negative (ycN0) status after neoadjuvant chemotherapy
- Written informed consent provided for study participation
You will not qualify if you...
- Metastatic breast cancer (Stage IV)
- Diagnosis of inflammatory or bilateral breast cancer
- History of axillary surgical procedures
- Medical, psychological, or social conditions preventing study adherence or completion
- Known allergy to carbon nanoparticles or severe comorbid or underlying medical conditions
- Current or previous participation in another conflicting clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
L
Lu Wang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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