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

Condition(s) studied

Investigational drug(s) / intervention(s)

Robot-assisted Nipple-Sparing Mastectomy (RNSM): Patients undergoing robot-assisted nipple-sparing mastectomy (RNSM) with immediate breast reconstruction (IBR) will be enrolled in this group. RNSM will be performed using robotic surgical platforms, including the da Vinci S, Si, X, Xi, and SP systems. The procedure will be conducted through an axillary or lateral chest wall incision. During surgery, posterior areolar tissue sampling for frozen section biopsy will be recommended. If suspicious lesions are detected at the superficial or posterior margins, frozen section biopsy of those lesions will also be performed. When tumor involvement of the nipple-areola complex (NAC), superficial margin, or posterior margin is confirmed by frozen section biopsy, additional resection including the skin and NAC, or postoperative radiotherapy, will be considered.

Conventional nipple sparing mastectomy(CNSM): Patients who undergo conventional nipple-sparing mastectomy (CNSM) with immediate breast reconstruction (IBR) will be enrolled in this group. CNSM is performed without the use of robotic or endoscopic surgical systems, and all types of skin incisions are permitted. During surgery, posterior areolar tissue sampling for frozen section biopsy is recommended. If suspicious lesions suggesting tumor involvement are identified at the superficial or posterior margins, frozen section biopsy should also be performed. When frozen section biopsy confirms tumor involvement of the nipple-areola complex (NAC), superficial margin, or posterior margin, additional excision including the skin and NAC, or postoperative radiotherapy, will be considered.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 5-year disease-free survival rate(DFS) — 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.

Trial sites (17)

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