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

University Hospital Ostrava61 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Sentinel lymph node biopsy (SLNB)PROCEDURE

Sentinel lymph node biopsy will be performed in the patients

Axillary dissectionPROCEDURE

Axillary dissection procedure will be performed in the patients

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Silesian Hospital in Opava

Opava, Moravian-Silesian Region, Czechia

University Hospital Ostrava

Ostrava-Poruba, Moravian-Silesian Region, Czechia

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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%.

Time frame: 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.

Time frame: 24 months

Overall Survival

The overall survival (in months, years) of the patients will be assessed.

Time frame: 24 months

Disease-free Survival

The disease-free survival (in months, years) of the patients will be assessed.

Time frame: 24 months

Progression-free Survival

The progression-free survival (in months, years) of the patients will be assessed.

Time frame: 24 months

Data from ClinicalTrials.gov

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