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

NCT ID NCT05490433

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

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.

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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

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