Efficacy of the delay procedure prior to nipple-sparing mastectomy: a randomized, controlled, open-label clinical trial

Abstract

Background Breast cancer represents the most recurrent tumor diagnosed and the first cause of death for cancer amongst Spanish women. Within those cases, 10% have a hereditary etiology. BRCA 1 and BRCA 2 mutations represent the most frequent breast-cancer susceptibility genes, displaying an accumulative risk of presenting breast cancer around 72% and 69% at 80 years old respectively. Therefore, rigorous screening and primary prevention to this vulnerable population is compulsory in order to reduce its breast cancer incidence. Mastectomy has shown to reduce the risk of breast cancer by at least 90% in women with BRCA 1 and/or BRCA 2 mutations. Nowadays there is a wide range of different mastectomies, standing out increasingly to more conservative procedures such as the skin-sparing mastectomy (SSM) or the nipple-sparing mastectomy (NSM). Purpose The main purpose of this study is to compare the effectiveness of the Delay procedure prior to the Nipple-Sparing Mastectomy versus the Nipple-Sparing Mastectomy itself in decreasing rates of necrosis as a postoperative complication in women with a BRCA mutation who are candidates of Risk-Reduction Mastectomy. Design A multicenter randomized controlled open-label clinical trial will be carried out in 20 hospitals through different autonomous communities in Spain. Participants Female carriers of deleterious mutations in either the BRCA1 or BRCA2 gene who wish to undergo a Risk-Reduction Mastectomy in the hospitals included in our study and who do not have an actual or previous breast and/or ovarian cancer. Interventions Delay Procedure prior to completion Nipple-Sparing Mastectomy versus the Nipple-Sparing Mastectomy itself. Outcomes Primary outcome will be Skin Ischemia and Necrosis of the NAC and flap mastectomy assessed with Skin Score from the Mayo Clinic; secondary outcomes will be Grade of Satisfaction and Aesthetic Outcome with the surgical procedure, Sexual impact, Skin and Nipple Sensation and Quality of Life, assessed with Breast-Q Questionnaire, Semmes Weinstein Monofilaments test, CSFQ-14-F Questionnaire and SF-36 Questionnaire respectively