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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556397
• Other study ID #: CHIR-01-sentinel
• Secondary ID: 11360/6199/1610/
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Sentinel lymph node biopsy (SLNB)
Sentinel lymph node biopsy will be performed in the patients
• Axillary dissection
Axillary dissection procedure will be performed in the patients

Locations

Country	Name	City	State
Czechia	Silesian Hospital in Opava	Opava	Moravian-Silesian Region
Czechia	University Hospital Ostrava	Ostrava-Poruba	Moravian-Silesian Region

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	Silesian Hospital in Opava

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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