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SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04250129
Acronym
NEOSENTITURK
Enrollment
500
Registered
2020-01-31
Start date
2018-01-31
Completion date
2023-01-31
Last updated
2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sentinel Lymph Node

Keywords

sentinel lymph node biopsy, Neoadjuvan chemotherapy

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.

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

Interventions

None listed

Sponsors

Federation of Breast Diseases Societies
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

T0-4, N1-3, M0

Exclusion criteria

Inflammatory breast cancer, pregnant patients Patients with metastatic disease

Design outcomes

Primary

MeasureTime frameDescription
Local recurrence free survivalJanuary 2023Breast and axillary recurrence rates

Secondary

MeasureTime frameDescription
Disease free survivalJanuary 2023Local recurrence and distant metastasis rates
Overall survivalJanuary 2023Overall survival

Countries

Turkey (Türkiye)

Contacts

Primary ContactNeslihan Cabioglu, Prof
ncabioglu@gmail.com+905325057724
Backup ContactHasan Karanlik, Prof
hasankaranlik@yahoo.com+905324025354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026