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

February 16, 2021 updated by: University Hospital Ostrava
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Opava, Moravian-Silesian Region, Czechia, 746 01
        • Silesian Hospital in Opava
      • Ostrava-Poruba, Moravian-Silesian Region, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cN0 before and after neoadjuvant th., SLNB - negative, no AD
Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD
Procedure: Sentinel lymph node biopsy (SLNB)
Sentinel lymph node biopsy will be performed in the patients
Experimental: 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)
Procedure: Sentinel lymph node biopsy (SLNB)
Sentinel lymph node biopsy will be performed in the patients
Procedure: Axillary dissection
Axillary dissection procedure will be performed in the patients
Experimental: 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)
Procedure: Sentinel lymph node biopsy (SLNB)
Sentinel lymph node biopsy will be performed in the patients
Procedure: Axillary dissection
Axillary dissection procedure will be performed in the patients
Experimental: cN1 after neoadjuvant therapy, SLNB, AD
Patients with cN1 after neoadjuvant therapy, SLNB, AD.
Procedure: Sentinel lymph node biopsy (SLNB)
Sentinel lymph node biopsy will be performed in the patients
Procedure: Axillary dissection
Axillary dissection procedure will be performed in the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clear indications for SLNB or axillary dissection
Time Frame: 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.
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

Silesian Hospital in Opava

Investigators

  • Principal Investigator: Jan Žatecký, MD, Silesian Hospital in Opava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIR-01-sentinel
  • 11360/6199/1610/021554 (Other Grant/Funding Number: Ostrava University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not decided to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Sentinel lymph node biopsy (SLNB)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe