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NCT number NCT03355261
Study type Interventional
Source Shengjing Hospital
Contact Jianyi Li, Master
Phone 8618940257177
Email sjbreast@yeah.net
Status Recruiting
Phase N/A
Start date May 1, 2014
Completion date May 2019

Clinical Trial Summary

To investigate the regression model of positive nodes after neoadjuvant chemotherapy (NAC) by injecting and tracing carbon nanoparticles (CNs) in fusion node prior to NAC in patients with breast cancer.


Clinical Trial Description

Approximate 20% of breast cancer survivors develop cancer-related arm lymphedema (BCRAL) which causes substantial functional impairment and psychological morbidity with no effective treatment. While the etiology of BCRL is complicated, the findings of a meta-analysis reviewing 72 studies demonstrated that axillary lymph node dissection (ALND), more extensive breast surgery, radiotherapy, chemotherapy, being overweight or obese and physical inactivity were consistently associated with increased BCRAL risk. One of the primary factors, the extent of ALND is positively correlated with BCRAL. Over the past 20 years, the increasing number of patients with early-stage breast cancer can avoid the risk of arm lymphedema caused by ALND in cases where the sentinel lymph nodes (SLNs) are negative for cancer cell. Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is a feasible and accurate tool in patients with operable T1-3, N1 and clinically node-negative breast cancer after therapy. Some studies, however, regarded the false negative rate (FNR) of 14% for SLNB after NAC as unacceptable when compared with the below 5% rate produced by the pioneers of SLNB. The placement of clips at the diagnosis of node-positive disease with removal of the clipped nodes during SLNB reduces the false negative rate FNR after NAC. Additionally, about 9% patients with positive node and T0-2 breast cancer have residual positive node in level III region after NAC. Therefore, it is essential to explore the regression model post NAC in patients who are node positive prior to NAC. Carbon nanoparticles (CNs) suspension contains nanosized polymeric carbon granules with an average diameter of 150 nm and ensures the passing of CNs through the lymphatic vessels (diameter 120-500 nm) rather than blood capillaries (diameter 20-50 nm) due to their molecular size. In the present study, CNs suspension was injected into fusion nodes guided by ultrasound in patients with advanced breast cancer before NAC, total ALND (from level I to III) and breast surgery were then performed after NAC. The distribution of CNs traced in axillary nodes was investigated to establish the regression model of positive nodes in relation to NAC.


Study Design


Related Conditions & MeSH terms


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