本阶段II研究评估了将利波西利与通过选择的内分泌治疗（ET）维持治疗相结合对于激素受体阳性（HR阳性）/人表皮生长因子受体2阴性（HER2阴性）转移性乳腺癌（mBC）的绝经前和绝经后妇女的影响。最初的随机对照研究设计后来改为单臂研究，随后所有患者均接受了利波西利和ET。主要终点为局部评估的无进展生存期（PFS）。次要终点包括总生存期（OS）、临床效益率（CBR）、安全性、依从性和生活质量（QoL）。共有43名患者接受了利波西利+ET，而10名患者只接受了ET。接受利波西利+ET的患者的中位PFS为12.4个月[95% CI 8.7-24.4]，只接受ET的患者的中位PFS为4.75个月[95% CI 1.0-10.3]。接受利波西利+ET的患者的中位OS尚未达到，有28名（65.1%）患者获得临床益处[95% CI 49.1-79.0]。对于接受利波西利+ET的患者，25名（58.1%）患者发生了3-4级血液学不良事件（AEs），17名（39.5%）患者发生了3-4级非血液学AEs。在研究期间，15名患者死亡，其中14名死于肿瘤相关原因，而一名患者死于非治疗相关的肺炎。AMICA研究的结果显示了将利波西利添加到首次转移性化疗后至少稳定疾病的ET的维持治疗在HR+/HER2-mBC患者中的有效性和安全性，NCT03555877，https://clinicaltrials.gov/ct2/show/NCT03555877。版权所有 © 2023 Elsevier Ltd.

This phase II study evaluated the impact of adding ribociclib to maintenance endocrine therapy (ET) treatment of physicians' choice following the first palliative chemotherapy in pre- and post-menopausal women with hormone receptor positive (HR+)/human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC).The initial randomized study design was later amended into a single-arm study, and all subsequent patients received ribociclib and ET. The primary end point was locally assessed progression-free survival (PFS). Secondary end points included overall survival (OS), clinical benefit rate (CBR), safety, compliance, and quality of life (QoL).A total of 43 patients received ribociclib + ET and 10 patients received ET only. Median PFS was 12.4 months [95% CI 8.7-24.4] for patients who received ribociclib + ET and 4.75 months [95% CI 1.0-10.3] for those who received ET only. Median OS was not reached for patients who received ribociclib + ET, and 28 (65.1%) patients experienced clinical benefit [95% CI 49.1-79.0]. For patients who received ribociclib + ET, grade 3-4 hematological adverse events (AEs) occurred in 25 (58.1%) patients, and grade 3-4 non-hematological AEs occurred in 17 (39.5%) patients. During the study, 15 patients died - 14 of whom due to tumor-related reasons, and one patient due to pneumonia, which was not treatment-related.The results of the AMICA study show a promising efficacy and safety of maintenance treatment with ribociclib added to ET after at least stable disease following the first metastatic chemotherapy in patients with HR+/HER2-mBC.Anti-hormonal Therapy With Ribociclib in HR-positive/HER2- Negative Metastatic Breast Cancer (AMICA), NCT03555877, https://clinicaltrials.gov/ct2/show/NCT03555877.Copyright © 2023. Published by Elsevier Ltd.