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NCT Number: NCT03556397

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Silesian Hospital in Opava, Opava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel Lymph Node Biopsy (SLNB)

Procedure

Sentinel lymph node biopsy will be performed in the patients

Axillary dissection

Procedure

Axillary dissection procedure will be performed in the patients

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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%.

  2. 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.

  3. Overall Survival

    Time frame: 24 months

    The overall survival (in months, years) of the patients will be assessed.

  4. Disease-free Survival

    Time frame: 24 months

    The disease-free survival (in months, years) of the patients will be assessed.

  5. Progression-free Survival

    Time frame: 24 months

    The progression-free survival (in months, years) of the patients will be assessed.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Silesian Hospital in Opava

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2018
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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