NCT04250129

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
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Federation of Breast Diseases Societies · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Sentinel Lymph Node

Timeline

• Start date: 2018-01-31
• Primary completion: 2021-12-31
• Completion: 2023-01-31
• First posted: 2020-01-31
• Last updated: 2020-01-31

Locations

3 sites across 1 country: Turkey (Türkiye)