NCT01622478

Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy Cancer Patients With Radiologically Positive Axillary Lymph Nodes

Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients With Radiologically Positive Axillary Lymph Nodes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate. Further, the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to determine the identification rate, the false-negative rate, and the accuracy of SLNB after NAC for node positive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Sentinel lymph node biopsy	Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation
DRUG	Neoadjuvant chemotherapy	Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis
PROCEDURE	complete axillary lymph node dissection	Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy
PROCEDURE	positron emission tomography and ultrasonogram	Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-06-01
• Completion: 2009-11-01
• First posted: 2012-06-19
• Last updated: 2012-08-15

Locations

1 site across 1 country: South Korea