VACUUM-ASSISTED EXCISION (VAE): ONE-STEP APPROACH TO THE DIAGNOSIS AND PERCUTANEOUS TREATMENT OF SMALL EARLY BREAST CANCER (THE VAE-BREAST 01 STUDY PROTOCOL)

Henrique Lima Couto^1,2*Bertha Coelho^2,3,4Bernardo Ricardo⁵Paola Hartung Toppa^6,7Aleida Nazareth Soares^6,8Bruna Torres Silvestre da Silva¹Douglas de Miranda Pires^1,2,9Tereza Oliveira¹Paula Clarke^1,10,2Shirley Ferreira^1,2Larissa Barbosa Oliveira^1,2ROMANA SALIBA^1,2Paula Cristina Martins Soares^1,2Thais Paiva Moraes^1,11,2Ana Carolina Guglielmelli Mendonça^1,2Amanda Cristina Braga de Oliveira^1,2Daniela Rodrigues Siqueira^1,2Jane Sanglard de Oliveira^1,2,9Charles Andreé Joseph de Padua¹²Geraldo Felício Cunha Jr¹²Marcus Simões Castilho¹³Bárbara Pace Silva Assis Carvalho^14,15,2Gabriel de Almeida Silva Jr^16,2Waldeir de Almeida Silva Jr^11,2,6CLECIO ENIO MURTA DE LUCENA^16,17,2Eduardo Carvalho Pessoa¹⁸Annamaria Massahud Rodrigues Santos^16,19Heverton Leal Ernesto de Amorim²⁰Ruffo de Freitas Junior²¹Marcus Nascimento Borges²¹Andre Mattar²²Marcelo Antonini²³Daniel de Araújo Brito Buttros²⁴Lorena Lima Coto Dominguez¹Bruna Pires¹Carolina Valadares²⁵Fernando Marcos dos Reis¹⁷

• ¹Redimama-Redimasto, Belo Horizonte, Brazil
• ²Brazilian Society of Mastology, Belo Horizonte, Brazil
• ³UNIFIMOC University Center, Belo Horizonte, Brazil
• ⁴MaterMOC Breast Unit, Montes Claros, Brazil
• ⁵Anatomia Laboratory, Belo Horizonte, Brazil
• ⁶Faculdade de Ciencias Medicas de Minas Gerais, Belo Horizonte, Brazil
• ⁷Analysis Laboratory, Belo Horizonte, Brazil
• ⁸Faculdade Santa Casa BH, Belo Horizonte, Brazil
• ⁹Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, Brazil
• ¹⁰Military Hospital (ISPM), Belo Horizonte, Brazil
• ¹¹Hospital Mater Dei, Belo Horizonte, Brazil
• ¹²Cetus Oncologia Belo Horizonte, Belo Horizonte, Brazil
• ¹³Radiocare, Belo Horizonte, Brazil
• ¹⁴Oncoclinicas, Belo Horizonte, Brazil
• ¹⁵Diagnostic Imaging Sonar, Belo Horizonte, Brazil
• ¹⁶Instituto Orizonti, Belo Horizonte, Brazil
• ¹⁷Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
• ¹⁸Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina, Botucatu, Brazil
• ¹⁹Minas Gerais State Servants Welfare Institute, Belo Horizonte, Brazil
• ²⁰UD Diagnóstico, João Pessoa, Brazil
• ²¹Universidade Federal de Goias, Goiânia, Brazil
• ²²Women Hospital, São Paulo, Brazil
• ²³Hospital of the State Public Servant of São Paulo, São Paulo, Brazil
• ²⁴Centro Universitario Claretiano Unidade Rio Claro, Rio Claro, Brazil
• ²⁵Hospital Paulistano, São Paulo, Brazil

Introduction: Vacuum-assisted excision (VAE) of breast lesions is a technique used for diagnostic and therapeutic purposes and is performed on an outpatient basis, with local anesthesia and image guidance. Currently, VAE is used in the management of benign lesions and lesions of uncertain malignant potential (B3 lesions). More recently, there has been interest in VAE for percutaneous treatment of small breast cancers with the aim of reducing morbidity and aggressive surgical treatment. The way conventional VAE is performed, histopathological assessment of resection margins is not possible. Obtaining free margins after a breast cancer resection is a primary objective in the surgical treatment of this disease. If VAE could ensure free margins and absence of residual tumor in the surgical excision, it would also be a safely used method for minimally invasive treatment, providing an effective percutaneous treatment of small early breast cancers. Methods: The prospective VAE-BReast 01 study explores the role of VAE associated with cavity margins sampling shaving (CMSH) as one-step approach in diagnosing and completing excising small breast tumors, ensuring the absence of residual disease in surgical pathology. Inclusion criteria are women with lesions smaller than 1.5 cm, ACR BI-RADS™ CATEGORY 4 OR 5, identified by screening or clinical alteration. Noninclusion criteria are multifocal, multicentric breast cancers and breast cancers associated with diffuse and extensive calcifications. Sensitivity, specificity, accuracy, positive predictive value, negative predictive value, false negative and false positive rate of VAE+CMSH for the complete excision of breast cancers will be calculated. The collected data will also encompass patients' demographics, image characteristics of the lesions, information regarding the VAE+CMSH and surgical procedure, biopsy and surgical pathology, as well as data on side effects, patient acceptance, cosmetic results and patients' experience during VAE. Ethics and dissemination Ethics approval has been obtained by the Brazilian National Research Ethics Commission (CONEP). Participants will provide written informed consent, and researchers will follow institutional guidelines for data collection and management.