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

University Hospital Ostrava

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Axillary dissection; Procedure: Sentinel lymph node biopsy (SLNB)

Study type: Interventional

Funder types: Other

Identifiers

NCT03556397

CHIR-01-sentinel

11360/6199/1610/021554 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Procedure: Sentinel lymph node biopsy (SLNB)

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

Experimental group

Description:

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

Treatment:

Procedure: Axillary dissection

Procedure: Sentinel lymph node biopsy (SLNB)

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

Experimental group

Description:

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

Treatment:

Procedure: Axillary dissection

Procedure: Sentinel lymph node biopsy (SLNB)

cN1 after neoadjuvant therapy, SLNB, AD

Experimental group

Description:

Patients with cN1 after neoadjuvant therapy, SLNB, AD.

Treatment:

Procedure: Axillary dissection

Procedure: Sentinel lymph node biopsy (SLNB)