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

Recruiting now · Not applicable

Conditions studied: Breast Cancer Classified as TNM Stage 0-IIIa

In brief

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.

Key facts

Study ID

NCT05490433

Run by

Yonsei University

People needed

790

Starts

2022-10-26

Expected to finish

2032-06-01

Last updated by the study team

2025-11-17

Who can join

Age: 19 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 ≥4.
• 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.

Where it is running

• Samsung Changwon Medical Center — Changwon, South Korea (enrolling)
• Keimyung University Dongsan Hospital — Daegu, South Korea (enrolling)
• Kyungpook National University Chilgok Hospital — Daegu, South Korea (enrolling)
• Kosin University Gospel Hospital — Pusan, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Yonsei University Health System, Severance Hospital — Seoul, South Korea (enrolling)
• Yongin Severance Hospital — Yongin-si, South Korea (enrolling)
• Myongji Hospital — Goyang-si, South Korea (enrolling)
• The Catholic University of Korea, Incheon ST. Mary's Hospital — Incheon, South Korea (enrolling)
• Yeungnam University Medical Center — Daegu, South Korea
• Gangnam Severance Hospital — Seoul, South Korea
• Soonchunhyang University Hospital Seoul — Seoul, South Korea
• Korea University Ansan Hospital — Seoul, South Korea
• Chungnam National University Sejong Hospital — Sejong, South Korea
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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