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SENTINEL LYMPH NODE BIOPSY AFTER NEOADJUVANT CHEMOTHERAPY (NEOSENTITURK)

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ClinicalTrials.gov Identifier: NCT04250129
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Federation of Breast Diseases Societies

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.

Condition or disease
Sentinel Lymph Node

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

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort
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)



Primary Outcome Measures :
  1. Local recurrence free survival [ Time Frame: January 2023 ]
    Breast and axillary recurrence rates


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: January 2023 ]
    Local recurrence and distant metastasis rates

  2. Overall survival [ Time Frame: January 2023 ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

T0-4, N1-3, M0

Exclusion Criteria:

Inflammatory breast cancer, pregnant patients Patients with metastatic disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250129


Contacts
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Contact: Neslihan Cabioglu, Prof +905325057724 ncabioglu@gmail.com
Contact: Hasan Karanlik, Prof +905324025354 hasankaranlik@yahoo.com

Locations
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Turkey
Istanbul University Institute of Oncology Recruiting
Istanbul, Turkey
Contact: Hasan Karanlik, Prof    +905324025354    hasankaranlik@yahoo.com   
Istanbul University Istanbul Faculty of Medicine Recruiting
Istanbul, Turkey
Contact: Neslihan Cabioglu, Prof         
Sub-Investigator: Abdullah Igci, Prof         
Sub-Investigator: Mahmut Muslumanoglu, Prof         
Sub-Investigator: Vahit Ozmen, Prof         
Bulent Ecevit University Faculty of Medicine Recruiting
Zonguldak, Turkey
Contact: Guldeniz Karadeniz Cakmak, Prof    05323371860      
Contact: Guldeniz Karadeniz Cakmak         
Sponsors and Collaborators
Federation of Breast Diseases Societies
Investigators
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Principal Investigator: Neslihan Cabioglu, Prof Istanbul University, Istanbul Faculty of Medicine
Study Director: Hasan Karanlik Istanbul University Institute of Oncology
Study Chair: Guldeniz Karadeniz Cakmak Bulent Ecevit University Faculty of Medicine
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Responsible Party: Federation of Breast Diseases Societies
ClinicalTrials.gov Identifier: NCT04250129    
Other Study ID Numbers: 2018-03
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federation of Breast Diseases Societies:
sentinel lymph node biopsy, Neoadjuvan chemotherapy