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
1 other identifier
observational
500
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2018
CompletedFirst Submitted
Initial submission to the registry
January 29, 2020
CompletedFirst Posted
Study publicly available on registry
January 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedJanuary 31, 2020
January 1, 2020
3.9 years
January 29, 2020
January 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local recurrence free survival
Breast and axillary recurrence rates
January 2023
Secondary Outcomes (2)
Disease free survival
January 2023
Overall survival
January 2023
Study Arms (3)
SLNB (-)&level 1-3 RT
SLNB (-)\&level 1-3 RT
SLNB (+)&level 1-3 RT
SLNB (+)\&level 1-3 RT
SLNB(+)&ALND&level 3 RT (+/-level 1-2)
SLNB(+)\&ALND\&level 3 RT (+/-level 1-2)
Eligibility Criteria
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.
You may qualify if:
- T0-4, N1-3, M0
You may not qualify if:
- Inflammatory breast cancer, pregnant patients Patients with metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Istanbul University Institute of Oncology
Istanbul, Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Bulent Ecevit University Faculty of Medicine
Zonguldak, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Neslihan Cabioglu, Prof
Istanbul University
- STUDY DIRECTOR
Hasan Karanlik
Istanbul University Institute of Oncology
- STUDY CHAIR
Guldeniz Karadeniz Cakmak
Bulent Ecevit University Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2020
First Posted
January 31, 2020
Study Start
January 31, 2018
Primary Completion
December 31, 2021
Study Completion
January 31, 2023
Last Updated
January 31, 2020
Record last verified: 2020-01