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

Study Overview
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Sentinel lymph node biopsy
* Drug: Neoadjuvant chemotherapy
* Procedure: complete axillary lymph node dissection
* Procedure: positron emission tomography and ultrasonogram


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinically node-positive patients before NAC<br>Patients with clinically positive lymph node receiving neoadjuvant chemotherapy Clinically negative-node after NAC Clinically positive-node after NAC | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation<br>Drug: Neoadjuvant chemotherapy<br>* Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis<br>Procedure: complete axillary lymph node dissection<br>* Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy<br>Procedure: positron emission tomography and ultrasonogram<br>* Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sentinel lymph node biopsy, neoadjuvant chemotherapy, breast cancer, locally advanced breast cancer, positive axillary lymph node, negative conversion