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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Sentinel lymph node biopsy (SLNB)

Axillary dissection

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, neoadjuvant therapy, sentinel lymph node biopsy, axillary dissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Silesian Hospital in Opava
University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

cN0 before and after neoadjuvant th., SLNB - negative, no AD

cN0 before and after neoadjuvant th., SLNB - posit., AD

cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD

cN1 after neoadjuvant therapy, SLNB, AD

Arm Description

Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD

Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)

Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II)

Patients with cN1 after neoadjuvant therapy, SLNB, AD.

Outcomes

Primary Outcome Measures

Clear indications for SLNB or axillary dissection

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

Morbidity

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

Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire.

Overall Survival

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

Disease-free Survival

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

Progression-free Survival

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

Full Information

NCT ID

NCT03556397

First Posted

May 24, 2018

Last Updated

February 16, 2021

Sponsor

University Hospital Ostrava

Collaborators

Silesian Hospital in Opava

1. Study Identification

Unique Protocol Identification Number

NCT03556397

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Ostrava

Collaborators

Silesian Hospital in Opava

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cN0 before and after neoadjuvant th., SLNB - negative, no AD

Arm Type

Experimental

Arm Description

Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD

Arm Title

cN0 before and after neoadjuvant th., SLNB - posit., AD

Arm Type

Experimental

Arm Description

Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)

Arm Title

cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD

Arm Type

Experimental

Arm Description

Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II)

Arm Title

cN1 after neoadjuvant therapy, SLNB, AD

Arm Type

Experimental

Arm Description

Patients with cN1 after neoadjuvant therapy, SLNB, AD.

Intervention Type

Procedure

Intervention Name(s)

Sentinel lymph node biopsy (SLNB)

Intervention Description

Sentinel lymph node biopsy will be performed in the patients

Intervention Type

Procedure

Intervention Name(s)

Axillary dissection

Intervention Description

Axillary dissection procedure will be performed in the patients

Primary Outcome Measure Information:

Title

Clear indications for SLNB or axillary dissection

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Morbidity

Description

Time Frame

24 months

Title

Changes in the Quality of Life

Description

Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire.

Time Frame

24 months

Title

Overall Survival

Description

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

Time Frame

24 months

Title

Disease-free Survival

Description

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

Time Frame

24 months

Title

Progression-free Survival

Description

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

Time Frame

24 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Only women with a history of breast carcinoma will be enrolled in the study.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Žatecký, MD

Organizational Affiliation

Silesian Hospital in Opava

Official's Role

Principal Investigator

Facility Information:

Facility Name

Silesian Hospital in Opava

City

Opava

State/Province

Moravian-Silesian Region

ZIP/Postal Code

746 01

Country

Czechia

Facility Name

University Hospital Ostrava

City

Ostrava-Poruba

State/Province

Moravian-Silesian Region

ZIP/Postal Code

708 52

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

23683750

Citation

Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.

Results Reference

background

PubMed Identifier

22847123

Citation

Caudle AS, Hunt KK, Tucker SL, Hoffman K, Gainer SM, Lucci A, Kuerer HM, Meric-Bernstam F, Shah R, Babiera GV, Sahin AA, Mittendorf EA. American College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patterns. Ann Surg Oncol. 2012 Oct;19(10):3144-51. doi: 10.1245/s10434-012-2531-z. Epub 2012 Jul 31.

Results Reference

background

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

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