A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer - Study Protocol

Sep 29, 2026

Uploaded by moss~

Axillary surgery is increasingly omitted in early-stage breast cancer, but neoadjuvant studies have mainly focused on small single-arm cohorts with highly selected patients and confirmed pathologic complete response. The NeoNAUTILUS trial evaluates oncologic safety of omitting sentinel lymph node biopsy in patients with a high likelihood of axillary pathologic complete response after neoadjuvant systemic therapy, irrespective of breast pCR status. The prospective multicenter randomized controlled noninferiority trial enrolls eligible women across 12 tertiary centers in Korea.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Abstract

Purpose

Methods

J Breast Cancer. 2025 Dec;28(6):437-447 [https://doi.org/10.4048/jbc.2025.0157](https://doi.org/10.4048/jbc.2025.0157)[ ](https://doi.org/10.4048/jbc.2025.0157)pISSN 1738-6756·eISSN 2092-9900 Study Protocol Received: Jun 30, 2025 Revised: Aug 21, 2025 Accepted: Oct 20, 2025 Published online: Nov 14, 2025 Correspondence to Wonshik Han Department of Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea. Email: [hanw@snu.ac.kr](hanw@snu.ac.kr) © The Authors 2025 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ([https://](https://)[ ](https://)[creativecommons.org/licenses/by-nc/4.0/](creativecommons.org/licenses/by-nc/4.0/)) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ORCID iDs Ji-Jung Jung [https://orcid.org/0000-0003-4080-1075](https://orcid.org/0000-0003-4080-1075)[ ](https://orcid.org/0000-0003-4080-1075)Hee Jeong Kim [https://orcid.org/0000-0002-1343-8138](https://orcid.org/0000-0002-1343-8138)[ ](https://orcid.org/0000-0002-1343-8138)Byung Joo Chae [https://orcid.org/0000-0003-1564-0978](https://orcid.org/0000-0003-1564-0978)[ ](https://orcid.org/0000-0003-1564-0978)[Eun-Kyu Kim](Eun-Kyu Kim) [https://orcid.org/0000-0003-1318-0939](https://orcid.org/0000-0003-1318-0939)[ ](https://orcid.org/0000-0003-1318-0939)Jee Hyun Ahn [https://orcid.org/0000-0003-4176-3277](https://orcid.org/0000-0003-4176-3277)[ ](https://orcid.org/0000-0003-4176-3277)Joon Jeong [https://orcid.org/0000-0003-0397-0005](https://orcid.org/0000-0003-0397-0005)[ ](https://orcid.org/0000-0003-0397-0005)Seeyoun Lee [https://orcid.org/0000-0002-7576-1512](https://orcid.org/0000-0002-7576-1512) A Randomized Trial of Sentinel Node Biopsy Omission After Neoadjuvant Systemic Therapy in Clinically Node-Negative or Selected Node-Positive Breast Cancer Ji-Jung Jung 1, Hee Jeong Kim 2, Byung Joo Chae 3, Eun-Kyu Kim 4, Jee Hyun Ahn 5, Joon Jeong 6, Seeyoun Lee 7, Seung Pil Jung 8, Joohyun Woo 9, Junwon Min 10, Jong-Ho Cheun 11, Min Sung Chung 12, Kyung Hwan Shin 13, Jung Min Chang 14, Woo Kyung Moon 14, Wonshik Han 1,15,16 1Department of Surgery, Seoul National University College of Medicine, Seoul, Korea 2Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 3Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea 4Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea 5Department of Surgery, Yonsei University College of Medicine, Seoul, Korea 6Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea 7Department of Surgery, Center for Breast Cancer, National Cancer Center, Goyang, Korea 8Department of Surgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea 9Department of Surgery, Ewha Womans University Mokdong Hospital, Ewha Womans University School of Medicine, Seoul, Korea 10Department of Surgery, Dankook University College of Medicine, Cheonan, Korea 11Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea 12Department of Surgery, Hanyang University College of Medicine, Seoul, Korea 13Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, Korea 14Department of Radiology, Seoul National University College of Medicine, Seoul, Korea 15Cancer Research Institute, Seoul National University, Seoul, Korea 16Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea ABSTRACT Purpose: Axillary surgery is increasingly omitted in patients with early-stage breast cancer undergoing upfront surgery, as supported by trials such as

FAQs

What question does the NeoNAUTILUS trial address?

Whether sentinel lymph node biopsy can be omitted after neoadjuvant systemic therapy in patients with a high probability of axillary pCR, regardless of breast pCR status.

Who is eligible to participate in the trial?

Women with clinical T1–T3, N0, or selected N1 invasive breast cancer who completed neoadjuvant systemic therapy and are candidates for breast-conserving surgery.

How is the trial designed?

A prospective multicenter randomized controlled noninferiority trial conducted at 12 tertiary centers in Korea.

Sep 29, 2026

Uploaded by moss~