Abstract P5-07-19: A multicenter, prospective, non-interventional study to investigate the treatment patterns of neratinib in Human Epidermal Growth Factor Receptor 2 positive (HER2+) early breast cancer (EBC) in China: NER-Tree study—An interim analysis on safety

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Abstract Background: Neratinib, an oral irreversible pan-HER tyrosine kinase inhibitor, was approved in 2020 in China for the extended adjuvant treatment of HER2+ early breast cancer (EBC) adult patients who completed prior adjuvant trastuzumab-based therapy based on the ExteNET trial. Diarrhea is a common treatment-related adverse event of neratinib, and it is necessary to investigate its pattern of occurrence and the effectiveness of anti-diarrheal prophylaxis measures in the real world. Method: This is a multi-center, prospective, non-interventional study planning to enroll 500 HER2+ EBC patients who scheduled 1-year neratinib treatment after anti-HER2 adjuvant therapy. Pre-specified interim analyses are planned after the recruitment of 250 and 500 patients. The primary and secondary objectives are to describe the real-world adjuvant treatment patterns and to observe the safety of patients treated with neratinib respectively. The exploratory objectives are to observe invasive disease recurrence patterns and patient-reported quality of life, including pattern of occurrence and the effectiveness of preventive measures for diarrhea. Patient characteristics and pre-treatment patterns from this interim analysis were previously presented at ESMO Breast Cancer 2024. Here we report safety data from the initial interim analysis with a focus on diarrhea and related management. Results: As of 21 September 2023, 250 patients were recruited in the study and were included in the interim analysis. According to this interim analysis, diarrhea, nausea, and abdominal pain were the most common AEs. Diarrhea, as the most frequent adverse event, occurred in 80.4% of patients (all grades), and grade 3 diarrhea occurred in 14.8% of patients. No grade 4 diarrhea was observed. The median time to onset of diarrhea was 3.0 days (interquartile range [IQR] 2.0,5.0). Diarrhea led to dose reduction in 12.8% of cases, dose interruption in 16.0%, and permanent discontinuation in 2.8% of cases. Patients who started on neratinib at <240 mg experienced a lower incidence of Grade ≥3 diarrhea compared to those who started at 240 mg (10.2% vs. 19.7%). There was no statistically significant difference in the incidence of diarrhea across different molecular subtypes of breast cancer (HR-/HER2+ vs HR+/HER2+), lymph node status, and adjuvant treatment regimens. One hundred and fifty-one patients (60.4%) received anti-diarrheal prophylaxis at least once, including drug prophylaxis (Loperamide or other agents, 33.2%), dose escalation (17.6%), and combination (dose escalation combined with drug prophylaxis, 9.6%). The dose escalation strategy reduced the incidence of Grade ≥3 diarrhea compared with prophylactic management with antidiarrheal(6.8% vs 18.1%). Conclusion: This study provides further data on safety, including the pattern of diarrhea occurrence and the impact of preventive anti-diarrheal measures in Chinese HER2+ early breast cancer patients treated with neratinib as extended adjuvant therapy. diarrhea, nausea, and abdominal pain were the most common AEs. The dose-escalation strategy can reduce the incidence of Grade 3 diarrhea associated with neratinib. Citation Format: Jin Zhang, Haiguang Liu, Xinlan Liu, Jidong Gao, Shihui Ma, Jinhui Ye, Yuanqi Zhang, Jundong Wu, Shuqun Zhang, Yongsheng Wang, Xinhong Wu, Jie Ma, Antai Zhang, Quchang Ouyang, Yiding Chen, Jianxia Liu, Hongwei Zhang, Guoqin Jiang, Zhaofeng Niu, Suisheng Yang, Fuguo Tian, Dong Song, Jie Wang, Mopei Wang, Qiang Zhang, Huanying Zhen, Xiaojia Wang. A multicenter, prospective, non-interventional study to investigate the treatment patterns of neratinib in Human Epidermal Growth Factor Receptor 2 positive (HER2+) early breast cancer (EBC) in China: NER-Tree study—An interim analysis on safety [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P5-07-19.

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