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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03556397

Enrollment

Registered

2018-06-14

Start date

2018-01-01

Completion date

2020-11-30

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, neoadjuvant therapy, sentinel lymph node biopsy, axillary dissection

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.

Interventions

PROCEDURESentinel lymph node biopsy (SLNB)

Sentinel lymph node biopsy will be performed in the patients

PROCEDUREAxillary dissection

Axillary dissection procedure will be performed in the patients

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

No roles in the study will be marked.

Intervention model description

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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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%.
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.
Overall Survival	24 months	The overall survival (in months, years) of the patients will be assessed.
Disease-free Survival	24 months	The disease-free survival (in months, years) of the patients will be assessed.
Progression-free Survival	24 months	The progression-free survival (in months, years) of the patients will be assessed.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026