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Completed

NCT Number: NCT01622478

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Gangnam Severance Hospital

Seoul, 135270, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure

Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation

Neoadjuvant chemotherapy

Drug

Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis

complete axillary lymph node dissection

Procedure

Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy

positron emission tomography and ultrasonogram

Procedure

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

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Acronym: VSNBNAC

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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