Status:
RECRUITING
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang Provincial Natural Science Foundation of China
Conditions:
Breast Cancer
Surgery
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherap...
Detailed Description
Objective: This study aims to assess the clinical feasibility, accuracy, and effectiveness of CNSI in targeted axillary dissection compared to traditional tissue marker clips in patients with breast c...
Eligibility Criteria
Inclusion
- Female patients aged 18 to 85 years are eligible.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
- Clinical re-staging must indicate an axillary node status of ycN0 following NAC.
- Participants must provide written informed consent to partake in the trial, acknowledging understanding and agreement to the procedures and risks involved.
Exclusion
- Patients with metastatic breast cancer (Stage IV).
- Diagnosed with inflammatory breast cancer or bilateral breast cancer.
- History of axillary surgical procedures.
- Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up.
- Known allergy to carbon nanoparticles or presence of severe comorbid conditions or other serious underlying medical issues.
- 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.
Key Trial Info
Start Date :
November 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2029
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04744506
Start Date
November 30 2024
End Date
July 15 2029
Last Update
February 12 2025
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310000