NCT04744506 Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
| NCT ID | NCT04744506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-11-30 |
| Primary Completion | 2028-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2024-11-30 with a primary completion date of 2028-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Huang Jian
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT04744506 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04744506 currently recruiting?
Yes, NCT04744506 is actively recruiting participants. Contact the research team at support@runtrial.com for enrollment information.
Where is the NCT04744506 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04744506 clinical trial?
NCT04744506 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Huang Jian at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 126 participants.
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