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

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Sentinel lymph node biopsy; Drug: Neoadjuvant chemotherapy; Procedure: complete axillary lymph node dissection; Procedure: positron emission tomography and ultrasonogram

• Registration Number: NCT01622478
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-06
• Study Completion: 2009-11
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Advanced breast cancer patients with node-positive proved in preoperative imaging study
• ECOG status 0-1

Exclusion Criteria

• No previous cancer history
• No previous chemotherapy history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinically node-positive patients before NAC	Sentinel lymph node biopsy	Patients with clinically positive lymph node receiving neoadjuvant chemotherapy 1. Clinically negative-node after NAC 2. Clinically positive-node after NAC
Clinically node-positive patients before NAC	Neoadjuvant chemotherapy	Patients with clinically positive lymph node receiving neoadjuvant chemotherapy 1. Clinically negative-node after NAC 2. Clinically positive-node after NAC
Clinically node-positive patients before NAC	complete axillary lymph node dissection	Patients with clinically positive lymph node receiving neoadjuvant chemotherapy 1. Clinically negative-node after NAC 2. Clinically positive-node after NAC
Clinically node-positive patients before NAC	positron emission tomography and ultrasonogram	Patients with clinically positive lymph node receiving neoadjuvant chemotherapy 1. Clinically negative-node after NAC 2. Clinically positive-node after NAC

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of