Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response

Jai Min Ryu; Hyunjun Lee; Wonshik Han; Han-Byoel Lee; Sung Gwe Ahn; Hee Jeong Kim; Hyung Seok Park; Ji Soo Choi; Haeyoung Kim; Won Kyung Cho; Jeong Eon Lee

doi:10.4048/jbc.2023.0264

Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response

J Breast Cancer. 2024 Apr;27(2):130-140. doi: 10.4048/jbc.2023.0264.

Authors

Jai Min Ryu^#¹, Hyunjun Lee^#¹, Wonshik Han^{2

3

4}, Han-Byoel Lee^{5

3

4}, Sung Gwe Ahn^{6

7}, Hee Jeong Kim⁸, Hyung Seok Park⁹, Ji Soo Choi^{10

11}, Haeyoung Kim¹², Won Kyung Cho¹², Jeong Eon Lee¹³

Affiliations

¹ Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
² Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
³ Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea.
⁴ Cancer Research Institute, Seoul National University, Seoul, Korea.
⁵ Department of Surgery, Seoul National University College of Medicine, Korea.
⁶ Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
⁷ Institute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, Korea.
⁸ Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
⁹ Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
¹⁰ Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
¹¹ Department of Digital Health, SAIHST, Sungkyunkwan University, Seoul, Korea.
¹² Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
¹³ Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. paojlus@hanmail.net.

^# Contributed equally.

Abstract

Purpose: The Avoid Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy (ASLAN) trial aims to demonstrate the oncologic safety of omitting axillary surgery in patients with excellent response after neoadjuvant chemotherapy (NACT) for early human epidermal growth factor 2 (HER2)-positive (+)/triple-negative breast cancer (TNBC) who have undergone breast-conserving surgery (BCS) and adjuvant radiotherapy. The ASLAN trial will provide crucial information that could change the procedure in highly selected patients undergoing axillary surgery after NACT.

Methods: ASLAN is a prospective, multicenter, and single-arm surgical trial. The recruitment will be conducted among five tertiary care hospitals in the Republic of Korea. The total number of patients to be recruited will be 178, and we plan to complete patient enrollment by December 2023. The enrollment is considered among patients with HER2+ breast cancer (BC) or TNBC at clinical stage T1-3N0-1M0 who are expected to achieve breast pathological complete response (BpCR) based on a combination of radiologic imaging and physical examination after NACT. BCS was performed on eligible patients. After BCS, patients who showed BpCR were enrolled with the omission of sentinel lymph node biopsy (SLNB). The primary study endpoint upon completion of this trial is 5-year recurrence-free survival, and the secondary endpoints include the 5-year ipsilateral breast tumor recurrence interval, 5-year ipsilateral axillary recurrence interval, 5-year distant metastasis-free survival, 5-year BC-specific survival, 5-year overall survival, 5-year contralateral BC-free survival, re-operation rate according to breast biopsy after NACT, adverse events within 5 years, and quality of life.

Discussion: Several clinical trials are currently underway to determine whether SLNB can be omitted after NACT in patients with HER2+ BC or TNBC that are expected to achieve pathologic complete response. The ASLAN trial is expected to provide valuable clues regarding the feasibility of omitting axillary surgery in highly selected patients.

Trial registration: ClinicalTrials.gov Identifier: NCT04993625. Registered on August 6, 2021. Clinical Research Information Service Identifier: KCT0006371. Registered on July 22, 2021.

Keywords: Breast Neoplasms; Neoadjuvant Therapy; Sentinel Lymph Node Biopsy; Triple Negative Breast Neoplasms.

Associated data

ClinicalTrials.gov/NCT04993625