Targeted removal of lymph nodes in breast cancer patients after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Huang Jian — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Lu Wang, Dr
• Email: support@runtrial.com
• Phone: 86-571-87315215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.