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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Feb 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new method for removing lymph nodes in women with breast cancer who have received chemotherapy before surgery. The researchers are testing a special injection called Carbon Nanoparticle Suspension Injection (CNSI) that helps doctors see and remove the lymph nodes more accurately compared to traditional methods that use clips. The goal is to make the surgery safer and more effective, leading to better outcomes for patients.

To participate, women aged 18 to 85 who have a confirmed diagnosis of breast cancer and specific lymph node conditions can join. However, those with advanced breast cancer, a history of certain surgeries, or other serious health issues would not be eligible. If you join this study, you can expect close monitoring and follow-up care as the team evaluates how well the new method works. Your involvement could help improve future breast cancer treatments for others.

Gender

FEMALE

Eligibility criteria

• 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.