RecruitingNot ApplicableNCT04744506

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

Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy (TADCOM): a Prospective, Multicenter, Randomized Controlled Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

126 participants

Start Date

Nov 30, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Surgery Lymph Node Metastases

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 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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a targeted approach to removing axillary (armpit) lymph nodes in breast cancer patients after pre-surgery chemotherapy, focusing only on the originally cancerous lymph nodes rather than removing all of them. **You may be eligible if...** - You are a woman between 18 and 85 years old - You have been diagnosed with breast cancer that had spread to 1–2 nearby lymph nodes before chemotherapy, but those nodes now appear cancer-free on imaging - Your cancer is classified as cT1–T4, N1–N2a, M0 - Your general health score is 0 or 1 (ECOG) - You have provided written informed consent **You may NOT be eligible if...** - You had more than 2 involved lymph nodes before chemotherapy - Your lymph nodes still appear cancerous after chemotherapy - You have distant metastases - You are unable to tolerate surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETissue Marker Clip

Tissue Marker Clip to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)

DRUGCarbon Nanoparticle Suspension Injection

Carbon Nanoparticle Suspension Injection to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)

DRUGCarbon Nanoparticle Suspension Injection

Carbon Nanoparticle Suspension Injection to be Placed around Primary Tumor (Before Neoadjuvant Chemotherapy for Breast Cancer)

Locations(1)

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

Hangzhou, Zhejiang, China

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NCT04744506

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