Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial

Ji-Jung Jung; Jong-Ho Cheun; Soo-Yeon Kim; Jiwon Koh; Jai Min Ryu; Tae-Kyung Yoo; Hee-Chul Shin; Sung Gwe Ahn; Seho Park; Woosung Lim; Sang-Eun Nam; Min Ho Park; Ku Sang Kim; Taewoo Kang; Jeeyeon Lee; Hyun Jo Youn; Yoo Seok Kim; Chang Ik Yoon; Hong-Kyu Kim; Hyeong-Gon Moon; Wonshik Han; Nariya Cho; Min Kyoon Kim; Han-Byoel Lee

doi:10.4048/jbc.2023.0265

Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial

J Breast Cancer. 2024 Feb;27(1):61-71. doi: 10.4048/jbc.2023.0265.

Authors

Ji-Jung Jung^#¹, Jong-Ho Cheun^#², Soo-Yeon Kim^#³, Jiwon Koh^#^{4

5}, Jai Min Ryu⁶, Tae-Kyung Yoo⁷, Hee-Chul Shin^{1

8}, Sung Gwe Ahn⁹, Seho Park¹⁰, Woosung Lim¹¹, Sang-Eun Nam¹², Min Ho Park¹³, Ku Sang Kim¹⁴, Taewoo Kang^{15

16}, Jeeyeon Lee¹⁷, Hyun Jo Youn¹⁸, Yoo Seok Kim¹⁹, Chang Ik Yoon²⁰, Hong-Kyu Kim^{1

21}, Hyeong-Gon Moon^{1

5

21}, Wonshik Han^{1

5

21}, Nariya Cho³, Min Kyoon Kim²², Han-Byoel Lee^{1

5

23}

Affiliations

¹ Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
² Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
³ Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.
⁴ Department of Pathology, Seoul National University College of Medicine, Seoul, Korea.
⁵ Cancer Research Institute, Seoul National University, Seoul, Korea.
⁶ Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
⁷ Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
⁸ Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.
⁹ Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
¹⁰ Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
¹¹ Department of Surgery, College of Medicine, Ewha Womans University, Seoul, Korea.
¹² Department of Surgery, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
¹³ Department of Surgery, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea.
¹⁴ Department of Breast Surgery, Gospel Hospital, Kosin University College of Medicine, Busan, Korea.
¹⁵ Department of Surgery, Pusan National University, School of Medicine, Busan, Korea.
¹⁶ Busan Cancer Center and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.
¹⁷ Department of Surgery, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
¹⁸ Department of Surgery, Jeonbuk National University Medical School, Jeonju, Korea.
¹⁹ Department of Surgery, Chosun University College of Medicine, Gwangju, Korea.
²⁰ Division of Breast Surgery, Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
²¹ Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea.
²² Department of Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea. likeicetea@hanmail.net.
²³ Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea. hblee.md@snu.ac.kr.

^# Contributed equally.

Abstract

Purpose: Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.

Methods: The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuum-assisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.

Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.

Trial registration: ClinicalTrials.gov Identifier: NCT05505357. Registered on August 17, 2022. Clinical Research Information Service Identifier: KCT0007638. Registered on July 25, 2022.

Keywords: Biopsy; Breast Neoplasms; Clinical Trial; Multicenter Study; Neoadjuvant Therapy.

Associated data

ClinicalTrials.gov/NCT05505357
CRiS/KCT0007638

Grants and funding

HA22C0098/MOHW/Ministry of Health and Welfare/Korea