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

NCT ID: NCT01622478

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Breast Cancer

Keywords

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sentinel lymph node biopsy neoadjuvant chemotherapy breast cancer locally advanced breast cancer positive axillary lymph node negative conversion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinically node-positive patients before NAC

Patients with clinically positive lymph node receiving neoadjuvant chemotherapy

1. Clinically negative-node after NAC
2. Clinically positive-node after NAC

Sentinel lymph node biopsy

Intervention Type PROCEDURE

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

Neoadjuvant chemotherapy

Intervention Type DRUG

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

complete axillary lymph node dissection

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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Sentinel lymph node biopsy

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

Intervention Type PROCEDURE

Neoadjuvant chemotherapy

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

Intervention Type DRUG

complete axillary lymph node dissection

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

Intervention Type PROCEDURE

positron emission tomography and ultrasonogram

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung Gwe Ahn

Research Fellow, Breast Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GNSBCC001

Identifier Type: -

Identifier Source: org_study_id