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Robots take on breast cancer surgery: a new trial tests safety and survival

NCT ID NCT05490433

Disease control Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares robot-assisted nipple-sparing mastectomy (RNSM) to conventional open surgery in women with early-stage breast cancer (stage 0 to IIIA) who want immediate breast reconstruction. About 790 participants will be randomly assigned to one of the two procedures. The main goal is to see if the robot-assisted approach is as good as open surgery in preventing cancer from coming back over five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
robot-assisted nipple-sparing mastectomy (RNSM)
What this could lead to
If successful, this could show that robot-assisted mastectomy is as safe and effective as open surgery, offering a less invasive option with similar cancer control.
What could go wrong
This is a non-inferiority trial, meaning it aims to prove the robot method is not worse than open surgery. It may not show clear benefits, and long-term outcomes are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 790 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer classified as TNM stage 0-iiia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Chungnam National University Sejong Hospital

    NOT_YET_RECRUITING

    Sejong, South Korea

  • Gangnam Severance Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Ansan Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Kosin University Gospel Hospital

    RECRUITING

    Pusan, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, South Korea

  • Myongji Hospital

    RECRUITING

    Goyang-si, South Korea

  • Samsung Changwon Medical Center

    RECRUITING

    Changwon, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Soonchunhyang University Hospital Seoul

    NOT_YET_RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea, Incheon ST. Mary's Hospital

    RECRUITING

    Incheon, South Korea

  • Yeungnam University Medical Center

    NOT_YET_RECRUITING

    Daegu, South Korea

  • Yongin Severance Hospital

    RECRUITING

    Yongin-si, South Korea

  • Yonsei University Health System, Severance Hospital

    RECRUITING

    Seoul, South Korea