NCT03355261

Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.

Detailed description

Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	complete remission (CR) group	According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
PROCEDURE	partial remission (PR) group	According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
PROCEDURE	stable disease (SD) group	According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
PROCEDURE	progressive disease (PD) group	According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2017-11-28
• Last updated: 2020-02-20

Locations

3 sites across 1 country: China