IntroductionNipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA.Methods and analysisThis is a single-arm prospective pilot study to determine the safety, efficacy and potential risks of RNSM. Up to 12 RNSM will be performed to assess the safety and feasibility of the procedure. Routine follow-up visits and study assessments will occur at 14 days, 30 days, 6 weeks, 6 months and 12 months. The primary outcome is to assess the feasibility of removing the breast gland en bloc using the RNSM technique. To assess safety, postoperative complication information will be collected. Secondary outcomes include defining benefits and challenges of RNSM for both surgeons and patients using surveys, as well as defining the breast and nipple-areolar complex sensation recovery following RNSM. Mainly, descriptive analysis will be used to report the findings.Ethics and disseminationThe RNSM protocol was reviewed and approved by the US Food and Drug Administration using the Investigational Device Exemption mechanism (reference number G200096). In addition, the protocol was registered with ClinicalTrials.gov (NCT04537312) and approved by The Ohio State University Institutional Review Board, reference number 2020C0094 (18 August 2020). The results of this study will be distributed through peer-reviewed journals and presented at surgical conferences.Trial registration numberNCT04537312.

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e13530 Background: Inflammatory breast cancer (IBC) is a rare and aggressive form of breast cancer that accounts for nearly 10% of breast cancer caused mortality. With an annual rate between 1-4% per year and 3-year overall survival (OS) of about 65%, timely completion of trimodal treatment including systemic therapy, surgery, and radiation therapy is essential. Prior studies have demonstrated impact of time to treatment on OS of non-IBC patients. The aim of this study was to examine the relationship between the time from diagnosis to treatment and outcomes for patients with IBC. Methods: Categorically matched patients who underwent treatment of inflammatory and non-inflammatory locally advanced breast cancer at an NCI-Designated Comprehensive Cancer Center from 2006-2016 were analyzed. Clinicopathologic factors were compared using Chi-square and Wilcoxon Rank Sum tests. Overall survival was assessed using Kaplan-Meier methods and log-rank tests. Results: Of 217 patients who underwent excision for breast cancer, 99 had an IBC diagnosis. All patients were female, 85% (n=84) white, and 98% (n=97) had single-sided breast disease. Thirty-one percent (n=31) of patients had clinically node positive (N1) disease, the majority were ER negative (53%), and 38% were HER2 positive. There was no difference in time from first abnormal mammogram to diagnosis between IBC vs non-IBC patients. Ninety-one percent (n=90) of IBC patients underwent neoadjuvant chemotherapy compared to 52% (n=61) of non-IBC patients (p<0.001). Only 27% (n=27) of IBC had a pathological complete response. IBC patients tended to present earlier with symptoms (p=0.054), begin chemotherapy sooner after diagnosis (median days: 10.5 vs 17.0, respectively; p=0.002), and were more likely to receive radiation earlier after surgery (p<0.001). However, IBC patients were also more likely to undergo surgery later (191 vs 153 days; p<0.001) and have a worse OS (p=0.006). While not statistically significant, there was a trend toward worse OS for IBC patients with delayed chemotherapy initiation (p=0.459). Conclusions: IBC is an aggressive form of breast cancer associated with poor OS. Patients with this diagnosis are more likely to receive trimodal therapy sooner, but this may not significantly improve their OS. Further studies are necessary to evaluate effect of time from presentation of initial symptoms to treatment initiation on outcomes.