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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Surgery; Lymph Node Metastases
• Interventions: Device: Tissue Marker Clip; Drug: Carbon Nanoparticle Suspension Injection

• Registration Number: NCT04744506
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 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.

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 cancer undergoing neoadjuvant chemotherapy (NAC).

Background: Breast cancer remains one of the most prevalent cancers among women globally. Neoadjuvant chemotherapy (NAC) has significantly advanced the management of locally advanced breast cancer, enabling more conservative surgical approaches and reducing the dependency on axillary lymph node dissection (ALND), which is often associated with long-term complications such as lymphedema and chronic pain. Traditional TAD methods using tissue marker clips have challenges including high costs and potential for marker loss. CNSI presents a novel approach with potential for enhanced surgical precision and reduced complication rates.

Methods: The study employs a multicenter, randomized controlled trial design to compare the outcomes of TAD using CNSI versus conventional clip-based methods. Patients with clinically node-positive breast cancer who achieve clinical node-negative status post-NAC are enrolled. The primary endpoints include the rate of successful lymph node retrieval, the incidence of surgical complications, and the accuracy of lymph node staging.

Innovation: CNSI is designed to improve the visibility and stability of lymph nodes during surgery, potentially increasing the precision of cancerous node removal and minimizing the need for subsequent surgical interventions. Its unique properties, such as the slow metabolic rate and strong pigmentation, ensure prolonged visibility and facilitate easier identification during surgery.

Significance: By enhancing the effectiveness of TAD, CNSI could transform clinical practices in breast cancer surgery, reducing the physical burden of surgery and improving the quality of life for patients. The study's findings could lead to broader adoption of CNSI in surgical oncology, setting a new standard for axillary management in breast cancer.

Conclusion: This research could significantly impact breast cancer treatment protocols by providing a safer, more cost-effective, and clinically advantageous method for axillary lymph node management, potentially leading to widespread changes in surgical approaches and patient outcomes.

Study Timeline

• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-09
• Status Verified: 2024-06
• Study Start: 2024-11-30
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-12
• Primary Completion: 2028-07-15
• Study Completion: 2029-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

1. breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0)
2. accord with the indications of neoadjuvant chemotherapy for breast cancer
3. informed consent has been signed
4. Preoperative anesthesia assessment is low to medium risk (ASA score)

Exclusion Criteria

1. There are absolute and relative contraindications of chemotherapy
2. Refuse surgery or can't tolerate surgery
3. Unable to cooperate or unwilling to place Marker
4. Pregnant women
5. Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on
6. Diabetes patients who are difficult to control
7. Excessive smokers
8. high risk of anesthesia
9. Any serious complications are not suitable for patients participating in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: CG-TAD Group	Tissue Marker Clip	US-guided clip insertion into suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and clipped LNs
Group 2: CN-LNM Group	Carbon Nanoparticle Suspension Injection	US-guided CNSI injection to tattoo suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and carbon-marked LNs
Group 3: PCN-MAP Group	Carbon Nanoparticle Suspension Injection	US-guided CNSI injection around primary tumor pre-NAC, additional US-guided clip placement for metastatic LN Post-NAC, TAD removing SLNs, carbon-marked LNs, and clipped LNs

Primary Outcome Measures

Name	Time	Method
Lymph node retrieval rate marked	Up to 2 months	The proportion of successfully retrieved marked lymph nodes will be calculated and compared among the study groups to evaluate the effectiveness of each marking technique.
Number of sentinel and marked lymph nodes	Up to 2 months	The mean, median, and range of the number of sentinel and marked lymph nodes harvested during surgery will be recorded and compared to assess the efficacy of the marking techniques in identifying lymph nodes of interest.
Concordance between marked and sentinel lymph nodes	Up to 2 months	The consistency between marked lymph nodes and intraoperatively identified sentinel lymph nodes will be evaluated by calculating the percentage of marked nodes that are also sentinel nodes and vice versa.
Complication rate	Up to 60 months	All surgery-related complications, including but not limited to hemorrhage, lymphedema, infection, pain, tissue damage, clip displacement, clip loss, absence of CNSI staining, and excessive CNSI staining, will be recorded and analyzed. The overall complication rate and rates for specific types of complications will be reported. The severity of complications will be assessed using the Clavien-Dindo classification to provide a standardized evaluation of complication severity.

Secondary Outcome Measures

Name	Time	Method
Axillary and distant recurrence rates	Up to 60 months	During the 2-year and 5-year follow-up periods, the axillary and distant recurrence rates will be monitored and reported for each study group to assess the long-term oncological outcomes of the different marking techniques.
Overall survival (OS), and disease-free survival (DFS)	Up to 60 months	OS and DFS will be monitored and reported for each study group at 2 years, 5 years, and other relevant time points. Kaplan-Meier analysis and Cox proportional hazards models will be used to estimate these endpoints and compare outcomes among the study groups.
Surgical duration	Up to 2 hours	The total time from the start of the surgery to the removal of the last lymph node will be calculated to analyze the efficiency of different techniques in terms of surgical time.
Postoperative complications	Up to 60 months	Complications such as lymphedema, infection, and pain will be assessed at specific time points (e.g., 1 month, 6 months, and 1 year post-surgery) using validated tools or scales (e.g., Common Terminology Criteria for Adverse Events, Brief Pain Inventory) to determine the safety profile of each marking technique and its impact on patient morbidity.
The Life Quality Index	Up to 24 months	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module 23 (EORTC QLQ-BR23) will be used to evaluate patients' quality of life before treatment, at 6 months, 1 year, and 2 years after treatment to assess the impact of the different marking techniques on patient-reported outcomes.
Positive tumor margin rate and re-excision surgery	Up to 6 months	For patients undergoing breast-conserving surgery, the proportion of positive tumor margins, defined as tumor cells at the inked margin or within 1 mm from the margin, will be evaluated postoperatively. The rate of re-excision surgery due to positive margins will also be assessed to evaluate the impact of the marking techniques on the accuracy of surgical resection and the need for additional interventions.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China