Sentinel lymph node biopsy versus clinical follow-up for women with early stage breast Cancer with negative clinical and sonographic axillary evaluation

• Grant number: 22/02652-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): May 01, 2022
• Effective date (End): April 30, 2023
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Luís Otávio Zanatta Sarian
• Grantee: Rafael Boava Souza
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

This submission aims to present a proposal for activities, at the Scientific Initiation level, to be developed by the student Rafael Boava Souza, within the scope of the Sentinel Lymph Node Biopsy project versus axillary clinical follow-up in women with early breast Cancer with negative axilla. To clinical and ultrasound examinations (VENUS), currently underway at the State University of Campinas and other partner universities and institutions. As it is a long-term, multicenter, randomized clinical trial, the study itself encompasses technical-scientific aspects that go far beyond the scope of scientific initiation. However, there are functions within the study compatible with the student's level of education, and this proposal aims to present the activities to be developed by the student. The aim of the study is to compare sentinel lymph node biopsy with no axillary surgery as an axilla approach in women with early breast Cancer with negative axilla on clinical and ultrasound examination. Subject and Methods: Randomized clinical trial, in which women with early breast cancer (up to 5 cm), with a negative clinical and ultrasonographic evaluation of the axilla, are randomized to clinical follow-up or sentinel lymph node biopsy as axillary treatment. The sample size calculated was 800 patients randomized with follow-up, with 400 cases in each group. The CI student will be responsible for accompanying the researchers in the process of recruiting and tabulating data, participating in the intermediate analyzes, and in the process of writing the study publications. (AU)