Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
FEMALE
NCT04744506

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

Age: 18Years - 85Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here