Comparing robot-assisted and open nipple-sparing mastectomy with immediate breast reconstruction
A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial
This study is testing if a robot-assisted surgery for breast cancer can be as safe and effective as traditional surgery for women needing nipple-sparing mastectomy and immediate breast reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 790 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | Female |
| Sponsor | Yonsei University Academic / other |
| Locations | 17 sites (Changwon and 16 other locations) |
| Trial ID | NCT05490433 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the oncological outcomes of robot-assisted nipple-sparing mastectomy (RNSM) compared to conventional nipple-sparing mastectomy (CNSM) in women with breast cancer. It aims to provide high-level evidence regarding the effectiveness and safety of RNSM, particularly in the context of immediate breast reconstruction. The study involves a multicenter randomized design, focusing on patients with breast cancer stages 0 to 3A who are scheduled for therapeutic mastectomy. The trial is conducted by the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group to standardize and teach this advanced surgical technique.
Who should consider this trial
Good fit: Ideal candidates are adult women over 19 years old with breast cancer stages 0-3A who desire immediate breast reconstruction.
Not a fit: Patients who are not candidates for immediate breast reconstruction or have advanced breast cancer (stage IIIB-IV) will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for breast cancer patients undergoing mastectomy and reconstruction.
How similar studies have performed: Previous studies have shown that robot-assisted surgical techniques can be feasible, but this specific comparison of RNSM and CNSM is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Changwon and 16 other locations
- Samsung Changwon Medical Center — Changwon, South Korea (Recruiting)
- Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
- Kyungpook National University Chilgok Hospital — Daegu, South Korea (Recruiting)
- Yeungnam University Medical Center — Daegu, South Korea (Not_yet_recruiting)
- Myongji Hospital — Goyang-si, South Korea (Recruiting)
- The Catholic University of Korea, Incheon ST. Mary's Hospital — Incheon, South Korea (Recruiting)
- Kosin University Gospel Hospital — Pusan, South Korea (Recruiting)
- Chungnam National University Sejong Hospital — Sejong, South Korea (Not_yet_recruiting)
- Asan Medical Center — Seoul, South Korea (Not_yet_recruiting)
- Gangnam Severance Hospital — Seoul, South Korea (Not_yet_recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Korea University Ansan Hospital — Seoul, South Korea (Not_yet_recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Soonchunhyang University Hospital Seoul — Seoul, South Korea (Not_yet_recruiting)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
- Yongin Severance Hospital — Yongin-si, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyung Seok Park, MD, PhD — Yonsei University
- Study coordinator: Hyung Seok Park, MD, PhD
- Email: imgenius@yuhs.ac
- Phone: 82-10-6760-2974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.