Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction

Background Robot-assisted nipple-sparing mastectomy (RNSM) has emerged as an approach for both breast cancer treatment and risk-reducing mastectomy in women carrying high-risk pathogenic variants. Although several studies have reported that RNSM is a feasible procedure, concerns remain that it is performed only by a small number of specialized surgeons, and data on oncologic outcomes and patient-reported outcomes (PROs) remain limited. Recently, the United States Food and Drug Administration and several expert surgeons have cautioned that robotic breast surgery should be performed only by highly trained specialists, and that the benefits, risks, and alternative treatment options must be thoroughly discussed with patients to ensure fully informed decision-making.

To promote the safe and standardized application of RNSM, the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) was established with the mission to evaluate, standardize, and disseminate this advanced surgical technique.

Study Design We designed a prospective, multicenter, randomized clinical trial (Robot vs. Open Nipple-sparing Mastectomy Trial; ROM Trial) to evaluate the oncologic outcomes of RNSM with immediate breast reconstruction (IBR), compared with conventional open nipple-sparing mastectomy (CNSM) with IBR.

Previous retrospective studies on robot-assisted endoscopic breast surgery have demonstrated a short learning curve, suggesting that the technique is feasible and reproducible even for less experienced surgeons. However, the absence of rigorously designed randomized controlled trials has been a major limitation in expanding the global adoption of robotic breast surgery. The ROM Trial was therefore established to address this unmet need.

Data Collection Clinical and pathological data to be collected include: height, weight, breast volume/weight, age, germline likely pathogenic/pathogenic mutation status, affected breast, bilaterality, breast ptosis, tumor size, TNM stage, histologic grade, histologic type, estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 index, nipple involvement, neoadjuvant/adjuvant treatment status, postoperative complications (Clavien-Dindo classification), operative time, margin involvement, postoperative drainage amount/duration, risk-reducing mastectomy (RRM) status, reconstruction type, recurrence status, healthcare cost data, and follow-up information.

Patient Satisfaction Assessment Between 3 and 12 months (±30 days) after the final surgery, patients will be surveyed using the validated Korean version of the BREAST-Q questionnaire to evaluate satisfaction with surgery.

Cost-Effectiveness Assessment (Optional) Cost-effectiveness according to surgical method will be evaluated between 3 and 12 months (±30 days) after the final surgery, using the Korean version of the EuroQol 5-Dimension (EQ-5D) questionnaire.

• 5-Year Overall Survival (OS) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• 5-Year Breast Cancer-Specific Survival (BCSS) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• 5-Year Distant Recurrence-Free Survival (DRFS) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• 5-Year Locoregional Recurrence-Free Survival (LRFS) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• 5-Year Nipple Recurrence Rate (NR) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• Positive Margin Rate (at Surgery) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• Conversion Rate to Open Surgery (RNSM Group Only; at Surgery) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• Operation time [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• 30-Day Postoperative Complication Rate [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• Clavien-Dindo Classification of Postoperative Complications (within 180 days) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]
• Flap or Implant Loss Rate (within 1 year postoperatively) [Срок оценки: Flap or implant loss within 1 year of surgery will be recorded and analyzed.]
• Patient-Reported Outcomes (between 3 and 12 months postoperatively) [Срок оценки: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)]