Clinical trial NCT03556397: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant therapy
sentinel lymph node biopsy
axillary dissection
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: Silesian Hospital in Opava
First posted: 2018-06-14
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Clear indications for SLNB or axillary dissection
timeFrame: 24 months
Secondary outcomes:
measure: Morbidity
timeFrame: 24 months
measure: Changes in the Quality of Life
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
measure: Disease-free Survival
timeFrame: 24 months
measure: Progression-free Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Opava
country: Czechia
facility: Silesian Hospital in Opava
state: Moravian-Silesian Region
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: Silesian Hospital in Opava
name: Jan Žatecký, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.