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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Axillary dissection

• Registration Number: NCT03556397
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-14
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cN0 before and after neoadjuvant th., SLNB - posit., AD	Sentinel lymph node biopsy (SLNB)	Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)
cN0 before and after neoadjuvant th., SLNB - negative, no AD	Sentinel lymph node biopsy (SLNB)	Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD
cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD	Sentinel lymph node biopsy (SLNB)	Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II)
cN1 after neoadjuvant therapy, SLNB, AD	Axillary dissection	Patients with cN1 after neoadjuvant therapy, SLNB, AD.
cN1 after neoadjuvant therapy, SLNB, AD	Sentinel lymph node biopsy (SLNB)	Patients with cN1 after neoadjuvant therapy, SLNB, AD.
cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD	Axillary dissection	Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II)
cN0 before and after neoadjuvant th., SLNB - posit., AD	Axillary dissection	Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)

Primary Outcome Measures

Name	Time	Method
Clear indications for SLNB or axillary dissection	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Morbidity	24 months	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%.
Progression-free Survival	24 months	The progression-free survival (in months, years) of the patients will be assessed.
Changes in the Quality of Life	24 months	Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire.
Disease-free Survival	24 months	The disease-free survival (in months, years) of the patients will be assessed.
Overall Survival	24 months	The overall survival (in months, years) of the patients will be assessed.

Trial Locations

Locations (2)

Silesian Hospital in Opava; 🇨🇿 Opava, Moravian-Silesian Region, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Moravian-Silesian Region, Czechia