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SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY (NEOSENTITURK)

F

Federation of Breast Diseases Societies

Status

Unknown

Conditions

Sentinel Lymph Node

Study type

Observational

Funder types

Other

Identifiers

NCT04250129
2018-03

Details and patient eligibility

About

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.

Full 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

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

T0-4, N1-3, M0

Exclusion criteria

Inflammatory breast cancer, pregnant patients Patients with metastatic disease

Trial design

500 participants in 3 patient groups

SLNB (-)&level 1-3 RT
Description:
SLNB (-)\&level 1-3 RT
SLNB (+)&level 1-3 RT
Description:
SLNB (+)\&level 1-3 RT
SLNB(+)&ALND&level 3 RT (+/-level 1-2)
Description:
SLNB(+)\&ALND\&level 3 RT (+/-level 1-2)

Trial contacts and locations

3

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Central trial contact

Neslihan Cabioglu, Prof; Hasan Karanlik, Prof

Data sourced from clinicaltrials.gov

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