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

NCT03556397 | Completed

• 2 other identifiers: CHIR-01-sentinel11360/6199/1610/021554
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Morbidity

  24 months

• Changes in the Quality of Life

  24 months

• Overall Survival

  24 months

• Disease-free Survival

  24 months

• Progression-free Survival

  24 months

Study Arms (4)

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

EXPERIMENTAL

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

Procedure: Sentinel lymph node biopsy (SLNB)

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

EXPERIMENTAL

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); Procedure: Axillary dissection

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

EXPERIMENTAL

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); Procedure: Axillary dissection

cN1 after neoadjuvant therapy, SLNB, AD

EXPERIMENTAL

Patients with cN1 after neoadjuvant therapy, SLNB, AD.

Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Axillary dissection

Interventions

Sentinel lymph node biopsy (SLNB) PROCEDURE

Sentinel lymph node biopsy will be performed in the patients

cN0 before and after neoadjuvant th., SLNB - negative, no AD; cN0 before and after neoadjuvant th., SLNB - posit., AD; cN1 after neoadjuvant therapy, SLNB, AD; cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD

Axillary dissection PROCEDURE

Axillary dissection procedure will be performed in the patients

cN0 before and after neoadjuvant th., SLNB - posit., AD; cN1 after neoadjuvant therapy, SLNB, AD; cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women with a history of breast carcinoma will be enrolled in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of breast carcinoma confirmed by biopsy
• neoadjuvant therapy
• examination of axillary lymph nodes clinically and by ultrasound
• surgical therapy after neoadjuvant therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Silesian Hospital in Opava: collaborator

Study Sites (2)

Silesian Hospital in Opava

Opava, Moravian-Silesian Region, 746 01, Czechia

Location

University Hospital Ostrava

Ostrava-Poruba, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (2)

• 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.

  PMID: 23683750 BACKGROUND

• 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.

  PMID: 22847123 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Jan Žatecký, MD

  Silesian Hospital in Opava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No roles in the study will be marked.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 14, 2018
• Study Start: January 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CZ (2)