为了分析口服米诺地佐循环应用卡培他滨联用吡罗替尼治疗HER2阳性转移性乳腺癌(MBC)患者的安全性和疗效，我们进行了一项前瞻性的Ⅱ期研究，采用单臂设计。HER2阳性患者口服米诺地佐循环卡培他滨每日500毫克，吡罗替尼每日400毫克。主要终点是无进展生存期（PFS）。其他终点包括客观缓解率（ORR），总生存期（OS），临床益处率（CBR）和安全性。该研究共纳入50例HER2阳性MBC患者，其中1例因非标准用药而被排除。中位PFS和OS分别为11.9个月（95%CI 8.8-14.6）和29.3个月（95%CI 24.4-34.8）。ORR为34.7%，CBR为81.6%，其中CR为2例（4.1%），PR为15例（30.6%），SD为23例（46.9%）。一线或二线治疗的中位PFS为12.2个月。最常见的治疗相关不良事件包括手足综合征、腹泻、呕吐和恶心。15例（30.6%）患者出现3级不良事件，其中手足综合征（12.2%）、腹泻（12.2%）、呕吐（4.1%）和恶心（2.0%）。观察到1例（2.0%）3级腹泻不良事件。米诺地佐循环卡培他滨联合应用是一种具有竞争力的疗法，可以改善HER2阳性转移性乳腺癌患者的耐受性。版权所有 © 2023. 由Elsevier公司出版。

To analyze the safety and efficacy of orally administered metronomic capecitabine plus pyrotinib in HER2 positive metastatic breast cancer (MBC) patients, we conducted a prospective phase II study with a single-arm design.HER2 positive patients received oral metronomic capecitabine 500 mg three times a day and pyrotinib 400 mg per day. The primary endpoint was progression-free survival (PFS). Other endpoints included objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR) and safety.The study included 50 patients with MBC that was HER2-positive, while 1 patient was excluded due to nonstandard medication. The median PFS and OS was 11.9 months (95%CI 8.8-14.6) and 29.3 months (95%CI 24.4-34.8) respectively. ORR was 34.7%, and CBR was 81.6% with 2 CR (4.1%), 15 PR (30.6%) and 23 SD (46.9%). The mPFS in first- or second-line treatment was 12.2 months. The most frequent treatment-related adverse events included hand-foot syndrome, diarrhea, vomiting and nausea. Grade 3 adverse events occurred in 15(30.6%) patients, including hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%). 1 grade 4 adverse event of diarrhea (2.0%) was observed.The combination of metronomic capecitabine and pyrotinib is a promising regimen with competitive efficacy and improved tolerability in HER2 positive metastatic breast cancer patients.Copyright © 2023. Published by Elsevier Ltd.