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队列1：

作为二次分析，通过具有以下测试序列的把关策略评估统计显著性

• ITT Ki-67 高表达人群 (N=2498) 中的 IDFS，两侧 p 值边界为 0.0424，并且 
• 第 1 组 Ki-67 高表达人群 (N=2003) 中的 IDFS，两侧 p 值边界为 0.0426。^1,2

探索性分析包括队列 1 Ki-67低表达人群 (N=1914) 中的 IDFS 和队列 2 (N=517) 中的 IDFS。^1-3

队列 2:

第 2 组 IDFS 的数据尚不成熟。^1-3

上次审阅日期：2024年1月30日

参考文献

1. Harbeck N, Johnston S, Fasching P, et al. High Ki-67 as a biomarker for identifying patients with high risk early breast cancer treated in monarchE. Poster presented at: 43rd Annual San Antonio Breast Cancer Symposium (SABCS Virtual); December 8-11, 2020. Accessed October 3, 2021. http://www.sabcs.org/Portals/SABCS2016/PD2%2001%20Nadia%20Harbeck.pdf?ver=2021-08-29-125001-927

2. Johnston SRD, Toi M, O'Shaughnessy J, et al; monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24(1):77-90. https://doi.org/10.1016/S1470-2045(22)00694-5

3. Rastogi P, O'Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol. 2024;42(9):987-993. https://doi.org/10.1200/jco.23.01994