Selective evaluation of clipped nodes: improving axillary evaluation after neoadjuvant therapy in node positive breast cancer patients

Abstract

Background: For patients with a breast cancer tumour that are positive for node metastases, the ALND is the recommended and standard therapeutic axillar procedure. In the most aggressive tumour types, neoadjuvant therapy has showed high rates of pCR, appearing both in the primary tumour and in the axillar node metastases. Many trials have studied the possibility to avoid an unnecessary ALND if the axillar status has turned into a negative status after the NACT. The studies propose performing a SLNB after the NACT. However, the FNR associated to this SLNB are considered too high to be an accepted procedure. Ways to increase the SLNB accuracy should be tested. Placing a clip in the node could decrease the current FNRs. Objective: The aim of this study is to determine if pathologic changes in clipped nodes predict better the nodal status by lowering the FNR, compared to SLNB alone without clips. We will also evaluate the sensitivity and specificity of the procedure. Design: A randomized, single-blinded, controlled trial will be performed in the Hospital Universitari Josep Trueta of Girona within the Mammary Pathology Unit, from January 2018 to April 2021. Methods: 110 patients with node positive early breast cancer will join the trial following a consecutive recruitment. Patients will be randomly placed in one of the two groups; Clip node and No clip node. For the statistical analysis of all data, T-student test, U-Mann Whitney test and Chi-Square test will be used. A confidence interval of 95% will be assumed and a p<0.05 will be considered to be statistically significant