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

NCT04744506 | Recruiting

• 1 other identifier: 2020-535
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Surgery; Lymph Node Metastases

Outcome Measures

Primary Outcomes (4)

• Lymph node retrieval rate marked

  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.

  Up to 2 months

• Number of sentinel and marked lymph nodes

  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.

  Up to 2 months

• Concordance between marked and sentinel lymph nodes

  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.

  Up to 2 months

• Complication rate

  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.

  Up to 60 months

Secondary Outcomes (6)

• Axillary and distant recurrence rates

  Up to 60 months

• Overall survival (OS), and disease-free survival (DFS)

  Up to 60 months

• Surgical duration

  Up to 2 hours

• Postoperative complications

  Up to 60 months

• The Life Quality Index

  Up to 24 months

Study Arms (3)

Group 1: CG-TAD Group

ACTIVE COMPARATOR

US-guided clip insertion into suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and clipped LNs

Device: Tissue Marker Clip

Group 2: CN-LNM Group

EXPERIMENTAL

US-guided CNSI injection to tattoo suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and carbon-marked LNs

Drug: Carbon Nanoparticle Suspension Injection

Group 3: PCN-MAP Group

EXPERIMENTAL

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

Drug: Carbon Nanoparticle Suspension Injection

Interventions

Tissue Marker Clip DEVICE

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

Group 1: CG-TAD Group

Carbon Nanoparticle Suspension Injection DRUG

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

Group 2: CN-LNM Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial Natural Science Foundation of China: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• Chen W, Pang L, Jin X, Chen H, Huang J. Targeted axillary dissection using carbon marking for patients with node-positive breast cancer following neoadjuvant therapy (TADCOM): study protocol for a prospective, multicenter, randomized controlled trial. BMC Cancer. 2024 Oct 15;24(1):1276. doi: 10.1186/s12885-024-13001-2.

  PMID: 39402559 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huang Jian

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang, Dr

CONTACT

86-571-87315215; support@runtrial.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: CG-TAD Group (Control) US-guided clip insertion into suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and clipped LNs Group 2: CN-LNM Group US-guided CNSI injection to tattoo suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and carbon-marked LNs Group 3: PCN-MAP Group 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

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: February 9, 2021
• Study Start: November 30, 2024
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2029
• Last Updated: February 12, 2025

Record last verified: 2024-06

Locations

CN (1)