SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY (NEOSENTITURK)

IS SENTINEL LYMPH NODE BIOPSY WITH RADIOTHERAPY ALONE WITHOUT AXILLARY LYMPH NODE DISSECTION SAFE FOLLOWING NEOADJUVANT CHEMOTHERAPY IN INITIALLY CLINICALLY AXILLA POSITIVE PATIENTS: NEOSENTITURK-TRIAL/MF-18-03

Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. In this study, the investigators evaluated factors affecting local recurrence and outcome in patients with locally advanced breast cancer (LABC), who underwent sentinel lymph node (SLN) with or without ALND after NAC.

Study Overview

• Status: Unknown
• Conditions: Sentinel Lymph Node

Detailed Description

All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. Axillary fine needle aspiration biopsy or Trucut biopsy is mandatory.

All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recommended.

All patients with clinally-negative axilla and underwent SLNB will be included into the study:

1. SLNB (-) & RT
2. SLNB (+) & RT
3. SLNB (+) & ALND & RT Radiotherapy details will be announced as supplementary

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Neslihan Cabioglu, Prof; Phone Number: +905325057724; Email: ncabioglu@gmail.com
• Study Contact Backup: Name: Hasan Karanlik, Prof; Phone Number: +905324025354; Email: hasankaranlik@yahoo.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University Istanbul Faculty of Medicine
    • Contact: Neslihan Cabioglu, Prof
    • Sub-Investigator: Abdullah Igci, Prof
    • Sub-Investigator: Mahmut Muslumanoglu, Prof
    • Sub-Investigator: Vahit Ozmen, Prof
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University Institute of Oncology
    • Contact: Hasan Karanlik, Prof; Phone Number: +905324025354; Email: hasankaranlik@yahoo.com
  • Zonguldak, Turkey
    • Recruiting
    • Bülent Ecevit University Faculty of Medicine
    • Contact: Guldeniz Karadeniz Cakmak, Prof; Phone Number: 05323371860
    • Contact: Guldeniz Karadeniz Cakmak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recomended.

Description

Inclusion Criteria:

T0-4, N1-3, M0

Exclusion Criteria:

Inflammatory breast cancer, pregnant patients Patients with metastatic disease

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
SLNB (-)&level 1-3 RT
SLNB (+)&level 1-3 RT
SLNB(+)&ALND&level 3 RT (+/-level 1-2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence free survival	Breast and axillary recurrence rates	January 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Local recurrence and distant metastasis rates	January 2023
Overall survival	Overall survival	January 2023

Collaborators and Investigators

• Sponsor: Federation of Breast Diseases Societies
• Investigators: Principal Investigator: Neslihan Cabioglu, Prof, Istanbul University; Study Director: Hasan Karanlik, Istanbul University Institute of Oncology; Study Chair: Guldeniz Karadeniz Cakmak, Bülent Ecevit University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2018
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): January 31, 2023

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: sentinel lymph node biopsy, Neoadjuvan chemotherapy
• Other Study ID Numbers: 2018-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No