Tianjin Hemei Aokang Pharmaceutical Technology Co., Ltd.

This is a Phase III, randomized, multicenter, 2-arm, open-label clinical trial designed to compare the safety and efficacy of Hemay022+Aromatase inhibitor(AI) with that of capecitabine + lapatinib in participants with ER+/HER2+ locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up.

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.

This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension.