[Translation] A single-arm, open-label phase I clinical study on the safety, tolerability, pharmacokinetics and pharmacodynamics of Hemay022 combined with capecitabine in the treatment of HER2-positive advanced breast cancer
主要目的:研究Hemay022联合卡培他滨口服给药在HER2阳性晚期乳腺癌患者中的耐受性和安全性并确定推荐的Ⅱ期剂量。 次要目的: (1)研究Hemay022联合卡培他滨在HER2阳性晚期乳腺癌患者中的药代动力学特征。 (2)初步探索Hemay022联合卡培他滨治疗HER2阳性晚期乳腺癌患者的临床有效性。
[Translation] Primary objective: To study the tolerability and safety of oral administration of Hemay022 combined with capecitabine in patients with HER2-positive advanced breast cancer and determine the recommended phase II dose. Secondary objectives: (1) To study the pharmacokinetic characteristics of Hemay022 combined with capecitabine in patients with HER2-positive advanced breast cancer. (2) To preliminarily explore the clinical efficacy of Hemay022 combined with capecitabine in the treatment of patients with HER2-positive advanced breast cancer.