Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy

Study Overview
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Brief Summary
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The aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.

Detailed Description
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The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.

Official Title
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Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Sentinel lymph node biopsy (SLNB)
* Procedure: Axillary dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of breast carcinoma confirmed by biopsy neoadjuvant therapy examination of axillary lymph nodes clinically and by ultrasound surgical therapy after neoadjuvant therapy Exclusion Criteria: inflammatory breast carcinoma incomplete neoadjuvant therapy previous sentinel lymph node biopsy performed on the same side of the body disagreement with participation in the study other malignities influencing the treatment of breast carcinoma distant metastases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cN0 before and after neoadjuvant th., SLNB - negative, no AD<br>Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD | Procedure: Sentinel lymph node biopsy (SLNB)<br>* Sentinel lymph node biopsy will be performed in the patients<br>|
| Experimental: cN0 before and after neoadjuvant th., SLNB - posit., AD<br>Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II) | Procedure: Sentinel lymph node biopsy (SLNB)<br>* Sentinel lymph node biopsy will be performed in the patients<br>Procedure: Axillary dissection<br>* Axillary dissection procedure will be performed in the patients<br>|
| Experimental: cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD<br>Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II) | Procedure: Sentinel lymph node biopsy (SLNB)<br>* Sentinel lymph node biopsy will be performed in the patients<br>Procedure: Axillary dissection<br>* Axillary dissection procedure will be performed in the patients<br>|
| Experimental: cN1 after neoadjuvant therapy, SLNB, AD<br>Patients with cN1 after neoadjuvant therapy, SLNB, AD. | Procedure: Sentinel lymph node biopsy (SLNB)<br>* Sentinel lymph node biopsy will be performed in the patients<br>Procedure: Axillary dissection<br>* Axillary dissection procedure will be performed in the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clear indications for SLNB or axillary dissection | Clear indications for SLNB or axillary dissection (AD) in women with breast carcinoma after neoadjuvant therapy using false-negativity rate of SLNB. False-negativity rate of SLNB under 10% is acceptable for avoiding AD. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Morbidity after SLNB and AD will be assessed by check-ups provided by clinicians. The result will be the percentage of patients which suffer from some complications after SLNB or AD. Common morbidity rate after AD is 20%, after SLNB 1-2%. | 24 months | 
| Changes in the Quality of Life | Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire. | 24 months | 
| Overall Survival | The overall survival (in months, years) of the patients will be assessed. | 24 months | 
| Disease-free Survival | The disease-free survival (in months, years) of the patients will be assessed. | 24 months | 
| Progression-free Survival | The progression-free survival (in months, years) of the patients will be assessed. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant therapy, sentinel lymph node biopsy, axillary dissection