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

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

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-11-30

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No roles in the study will be marked.

Study Groups

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cN0 before and after neoadjuvant th., SLNB - negative, no AD

Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD

Group Type EXPERIMENTAL

Sentinel lymph node biopsy (SLNB)

Intervention Type PROCEDURE

Sentinel lymph node biopsy will be performed in the patients

cN0 before and after neoadjuvant th., SLNB - posit., AD

Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)

Group Type EXPERIMENTAL

Sentinel lymph node biopsy (SLNB)

Intervention Type PROCEDURE

Sentinel lymph node biopsy will be performed in the patients

Axillary dissection

Intervention Type PROCEDURE

Axillary dissection procedure will be performed in the patients

cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD

Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II)

Group Type EXPERIMENTAL

Sentinel lymph node biopsy (SLNB)

Intervention Type PROCEDURE

Sentinel lymph node biopsy will be performed in the patients

Axillary dissection

Intervention Type PROCEDURE

Axillary dissection procedure will be performed in the patients

cN1 after neoadjuvant therapy, SLNB, AD

Patients with cN1 after neoadjuvant therapy, SLNB, AD.

Group Type EXPERIMENTAL

Sentinel lymph node biopsy (SLNB)

Intervention Type PROCEDURE

Sentinel lymph node biopsy will be performed in the patients

Axillary dissection

Intervention Type PROCEDURE

Axillary dissection procedure will be performed in the patients

Interventions

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Sentinel lymph node biopsy (SLNB)

Sentinel lymph node biopsy will be performed in the patients

Intervention Type PROCEDURE

Axillary dissection

Axillary dissection procedure will be performed in the patients

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No