[Translation] A randomized, open-label, controlled, multicenter phase III clinical study to evaluate the efficacy and safety of Hemay022 combined with an aromatase inhibitor in postmenopausal HER2+/ER+ advanced breast cancer patients treated with a trastuzumab-containing regimen
主要研究目的:基于 IRC 评估的无进展生存期 PFS,评估 Hemay022 联合 AI治疗 ER 阳性和 HER2 阳性晚期乳腺癌患者的有效性。关键次要目的:基于受试者的 OS 评估 Hemay022 联合 AI治疗 ER阳性和 HER2 阳性晚期乳腺癌患者的有效性。其他次要目的:基于研究者评估的 PFS、ORR、DCR、DOR 等指标进一步评估 Hemay022联合 AI治疗 ER 阳性和 HER2 阳性晚期乳腺癌患者的有效性。
[Translation] MAIN STUDY OBJECTIVE: To evaluate the efficacy of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on IRC-assessed PFS. Key secondary objective: To assess the efficacy of Hemay022 in combination with AI in patients with ER-positive and HER2-positive advanced breast cancer based on subject OS. Other secondary objectives: To further evaluate the efficacy of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on PFS, ORR, DCR, DOR and other indicators assessed by the investigator.