Comparing robot-assisted and open nipple-sparing mastectomy with immediate breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.