[Translation] An open-label, randomized, multicenter phase III study evaluating ESG401 versus investigator-selected chemotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer who have received at least one line of systemic chemotherapy
主要目的:对比ESG401与研究者所选化疗方案由独立中心影像评估的无疾病进展时间(PFS)。
次要目的:对比ESG401与研究者所选化疗方案由研究者评估的无疾病进展(PFS),总生存期(OS),客观缓解率(ORR),临床获益率(CBR),缓解持续时间(DOR)。
[Translation] Primary objective: To compare the progression-free time (PFS) assessed by independent central imaging between ESG401 and the chemotherapy regimen selected by the investigator.
Secondary objective: To compare the progression-free time (PFS), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR) assessed by the investigator between ESG401 and the chemotherapy regimen selected by the investigator.