Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Surgery; Neoadjuvant Therapy; Sentinel Lymph Node Biopsy (SLNB)
• Interventions: Drug: carbon suspension

• Registration Number: NCT07032220
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. This was done to investigate the detection rate of carbon nanoparticle-labeled lymph nodes and to assess the stability and safety of carbon nanoparticles. Additionally, the dye single tracer method was employed for sentinel lymph node biopsy to evaluate the false-negative rate of TAD. This is an open-label, single-arm, multi-center prospective clinical trial. The primary objectives of this study are to evaluate the accuracy, feasibility, and safety of this method, thereby improving the quality of life and reducing postoperative complications for breast cancer patients while ensuring treatment efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-09
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2027-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 175

Inclusion Criteria

1. women aged 18-70 years
2. The primary breast lesion was confirmed as invasive breast cancer by core needle biopsy
3. Axillary lymph node metastasis confirmed by fine needle aspiration or core needle biopsy
4. plan to undergo neoadjuvant chemotherapy
5. operable breast cancer
6. Patients with good heart, lung, liver, and kidney function are suitable for surgery
7. Informed consent

Exclusion Criteria

1. Surgery is not planned or impossible
2. Metastasis of supraclavicular lymph nodes
3. distant metastasis, excluding bone metastasis
4. previous ipsilateral axillary surgery or radiotherapy
5. Due to personal or family factors, the patient is unable to cooperate with the surgical treatment recommended by the doctor according to the condition (breast conserving surgery or radical surgery).
6. Patients with severe heart and lung diseases, uncontrolled infectious diseases and other non-tumor related diseases could not tolerate comprehensive treatment such as surgery and chemotherapy
7. Unable to sign the informed consent form due to mental illness or other reasons
8. Poor medical compliance, and the study group believed that the patients could not complete the trial treatment process and follow-up according to the standard

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility and Accuracy of Targeted Axillary Dissection of Carbon Tattooing	carbon suspension	-

Primary Outcome Measures

Name	Time	Method
By analyzing the detection rate of TAD, FNR and NPV, the feasibility and accuracy of this method in evaluating axillary lymph nodes of breast cancer patients after neoadjuvant therapy were evaluated.	24 months

Secondary Outcome Measures

Name	Time	Method
The feasibility and accuracy of TLNB and SLNB in axillary lymph node evaluation were evaluated by analyzing the detection rate of TLNB and SLNB, FNR and NPV.	24 months

Trial Locations

Locations (1)

Study Officials; 🇨🇳 Fuzhou, Fujian, China