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

Breast Cancer Clinical Trial

— VSNBNAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622478
• Other study ID #: GNSBCC001
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: August 14, 2012
• Start date: December 2006
• Est. completion date: November 2009

Study information

• Verified date: August 2012
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• positron emission tomography and ultrasonogram
Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of,