Targeted removal of lymph nodes in breast cancer patients after chemotherapy

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

This study is testing a new way to remove lymph nodes in breast cancer patients after chemotherapy to see if it works better and is safer than the usual methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04744506 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and feasibility of using Carbon Nanoparticle Suspension Injection (CNSI) for targeted axillary dissection in breast cancer patients who have undergone neoadjuvant chemotherapy. It compares CNSI to traditional clip-based methods to enhance the precision of lymph node removal and reduce surgical complications. The study is a multicenter, randomized controlled trial focusing on clinical outcomes such as lymph node retrieval rates and surgical staging accuracy. By improving visibility and stability during surgery, the study aims to establish a safer and more effective approach to managing axillary lymph nodes in breast cancer surgery.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 85 with clinically node-positive breast cancer who achieve clinical node-negative status after neoadjuvant chemotherapy.

Not a fit: Patients with metastatic breast cancer, inflammatory breast cancer, or those who have undergone prior axillary surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more precise lymph node removal and fewer complications for breast cancer patients.

How similar studies have performed: While traditional methods have been widely used, the use of CNSI represents a novel approach that has not been extensively tested in prior studies.

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.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Huang Jian — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Lu Wang, Dr

Conditions Breast Cancer; Surgery; Lymph Node Metastases