Abstract PS5-08-02: Vacuum Assisted Excision (VAE): A single-step approach to the diagnosis and percutaneous treatment of Early Breast Cancer (THE VAE BReast 01 TRIAL)

Abstract 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 the application of VAE for the percutaneous treatment of small breast cancers with the aim of reducing morbidity and aggressive surgical treatment of breast cancers detected by screening programs. 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 resection cavity, this would also be a method safely used for minimally invasive treatment, providing an effective percutaneous treatment of early breast cancers. Objectives: evaluate the effectiveness of vacuum-assisted excision associated with percutaneous sampling of cavity margins for the complete resection of breast cancers ensuring the absence of residual disease in surgical pathology. Methods: Inclusion criteria are women with unifocal lesions smaller than 1.5 cm, Category 4 or 5 ACR BI-RADS™, identified by screening or clinical alteration. Non-inclusion criteria are multifocal and multicentric breast cancers, breast cancers associated with diffuse and extensive microcalcifications. Sensitivity, specificity, accuracy, positive predictive value, negative predictive value, false negative and false positive rate of vacuum-assisted excision associated with percutaneous sampling of cavity margins for the complete resection of breast cancers will be calculated. The data collected will also encompass demographics, characteristics of the lesion, and information regarding the biopsy, surgical pathology, and surgical procedures, as well as data on side effects, patient acceptance, cosmetic results and patients’ experience during VAE (BreastQ questionnaire). Ethics and dissemination: Ethics approval has been obtained by the Brazilian National Research Ethics Commission (CONEP) 61781922.5.0000.5109 and is registered in Brazilian Registry of Clinical Trials (https://ensaiosclinicos.gov.br/), identifier U1111-1301-4235. Participants will provide written informed consent, and researchers will follow institutional guidelines for data collection and management. Citation Format: H. L. Couto, B. A. Coelho, T. C. Oliveira, B. F. Ricardo, P. H. Toppa, D. d. Pires, S. d. Ferreira, L. B. Oliveira, A. C. Mendonça, R. G. Saliba, T. P. Moraes, P. C. Soares, C. A. Padua, G. F. Cunha Júnior, M. S. Castilho, L. L. Dominguez, J. S. Oliveira, A. C. Oliveira, D. R. Siqueira, B. A. Pires, A. Mattar, G. d. Silva Junior, M. Antonini, E. C. Pessoa, F. M. Reis, BreastMit Collaborative Research Group. Vacuum Assisted Excision (VAE): A single-step approach to the diagnosis and percutaneous treatment of Early Breast Cancer (THE VAE BReast 01 TRIAL) [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-08-02.