Clinical trial NCT04250129: SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sentinel Lymph Node
Keywords: sentinel lymph node biopsy, Neoadjuvan chemotherapy
Lead sponsor: Federation of Breast Diseases Societies
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: Inclusion Criteria:

T0-4, N1-3, M0

Exclusion Criteria:

Inflammatory breast cancer, pregnant patients Patients with metastatic disease

Primary outcomes:
measure: Local recurrence free survival
timeFrame: January 2023
Secondary outcomes:
measure: Disease free survival
timeFrame: January 2023
measure: Overall survival
timeFrame: January 2023
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Institute of Oncology
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
city: Zonguldak
country: Turkey
facility: Bulent Ecevit University Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Neslihan Cabioglu, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Institute of Oncology
name: Hasan Karanlik
role: STUDY_DIRECTOR
affiliation: Bulent Ecevit University Faculty of Medicine
name: Guldeniz Karadeniz Cakmak
role: STUDY_CHAIR
References: