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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556397
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Silesian Hospital in Opava
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Sentinel lymph node biopsy (SLNB) Procedure: Axillary dissection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.
Masking: None (Open Label)
Masking Description: No roles in the study will be marked.
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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. Quality of Life [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women with a history of breast carcinoma will be enrolled in the study.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556397


Contacts
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Contact: Petr Vávra, Ass.Prof.,MD,Ph.D. 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
Silesian Hospital in Opava Recruiting
Opava, Moravian-Silesian Region, Czechia, 746 01
Contact: Jan Žatecký, MD    00420776193203    janzatecky.jz@gmail.com   
Principal Investigator: Jan Žatecký, MD         
University Hospital Ostrava Recruiting
Ostrava-Poruba, Moravian-Silesian Region, Czechia, 708 52
Contact: Petr Vávra, Ass.Prof.,MD,Ph.D.    0042059737 ext 2544    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Otakar Kubala, MD,Ph.D.         
Sub-Investigator: Jiří Prokop, MD         
Sponsors and Collaborators
University Hospital Ostrava
Silesian Hospital in Opava
Investigators
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Principal Investigator: Jan Žatecký, MD Silesian Hospital in Opava
Publications:
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03556397    
Other Study ID Numbers: CHIR-01-sentinel
11360/6199/1610/021554 ( Other Grant/Funding Number: Ostrava University )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
breast cancer
neoadjuvant therapy
sentinel lymph node biopsy
axillary dissection
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases