A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 790
- 试验地点
- 18
- 主要终点
- 5-year disease-free survival rate(DFS)
研究概览
简要总结
Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction (IBR) conducted in conjunction with robot-assisted nipple-sparing mastectomy (RNSM).
Study Design Overview This study is a prospective, multicenter, randomized clinical trial (ROM Trial) designed to compare the oncologic outcomes of robot-assisted nipple-sparing mastectomy (RNSM) with conventional nipple-sparing mastectomy (CNSM), which includes both traditional and open-chest approaches. Previous retrospective studies of robot-assisted endoscopic surgery have suggested a short learning curve, demonstrating technical feasibility and reproducibility even for less experienced surgeons. However, the absence of rigorously designed randomized clinical trials remains a major global barrier to the broader adoption of robotic breast surgery.
In the ROM Trial, eligible patients who provide written informed consent will be randomly assigned in a 1:1 ratio to undergo either RNSM or CNSM. Participants will be blinded to group allocation until the day of surgery (single-blind design). Immediate breast reconstruction (IBR) will be performed in all patients, with the reconstruction method determined in consultation with the breast and/or plastic surgeon following mastectomy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (≥19 years) scheduled to undergo therapeutic mastectomy for breast cancer who desire immediate breast reconstruction (IBR).
- •Breast cancer classified as clinical TNM stage 0 to IIIA, based on preoperative evaluation according to the 8th edition of the AJCC anatomic staging system.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Patients scheduled for breast-conserving surgery or deemed ineligible for immediate breast reconstruction (IBR).
- •Clinical evidence of nipple or skin involvement on preoperative evaluation.
- •Pregnant or breastfeeding women.
- •Tumors consisting exclusively of lobular carcinoma in situ (LCIS).
- •Paget's disease of the breast.
- •Inflammatory breast cancer.
- •Male breast cancer.
- •Clinical stage IIIB-IV disease on preoperative evaluation.
- •breast size equal to or larger than cup E
- •History of breast cancer or bilateral breast cancer (including metachronous or synchronous disease).
- •History of non-breast malignancy, with the exception of non-melanoma skin cancer or papillary/follicular thyroid carcinoma.
- •Special histologic subtypes of breast tumors (e.g., phyllodes tumor, sarcoma, lymphoma).
- •Age >70 years.
- •American Society of Anesthesiologists (ASA) physical status classification grade ≥
- •Inability to provide informed consent.
- •History of prior chest radiotherapy.
- •Patients who have not undergone preoperative testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), which is required for liability insurance coverage.
结局指标
主要结局
5-year disease-free survival rate(DFS)
时间窗: The DFS period is calculated from the date of surgery to the time of the first event, or censored at the date of last follow-up if no event is reported.
From the date of surgery to the first qualifying event, or censored at the date of last follow-up if no event occurs * Events: local/regional/distant recurrence, contralateral breast cancer, or all-cause mortality. * Local recurrence: recurrence in the ipsilateral breast or chest muscles, ipsilateral chest wall, or nipple-areola complex (NAC). * Regional recurrence: recurrence in the ipsilateral axillary lymph nodes, ipsilateral infra/supraclavicular lymph nodes, or ipsilateral internal mammary lymph nodes. * intraepithelial carcinoma is included as an event for local recurrence and contralateral breast cancer. * patients without an event are censored at the last known disease assessment. Statistical analysis (non-inferiority) * DFS will be analyzed using a Cox proportional hazards model stratified by institution and clinical stage. * The hazard ratio (HR) for RNSM vs CNSM and its 95% confidence interval (CI) will be estimated.
次要结局
- Operation time(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 Overall Survival (OS)(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)(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)(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)(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)(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)(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)(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(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(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)(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)(Flap or implant loss within 1 year of surgery will be recorded and analyzed.)
- Patient-Reported Outcomes (between 3 and 12 months postoperatively)(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))
- Surgeon Satisfaction (between 3 and 12 months postoperatively)(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))
- Cost-Effectiveness (between 3 and 12 months postoperatively; optional)(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 Estimated Postoperative Complication Rate(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))