[Translation] A multicenter, randomized, controlled, open-label clinical trial of SNG1005 versus investigator's choice of chemotherapy in patients with HER2-negative breast cancer who have previously been treated for brain metastases and have newly diagnosed leptomeningeal metastases
比较两组的总生存期(OS);CNS(软脑膜和脑实质)的无进展生存期(PFS)、CNS(软脑膜和脑实质)在第3、6和12个月的临床获益率(疾病稳定或改善)、6个月和12个月的总体生存率、LC缓解率(RR)和缓解持续时间(DoR)、三阴性(HER2-/ER-/PR-)乳腺癌受试者的OS
安全性:确定SNG1005的安全性和耐受性。
[Translation] Compare the overall survival (OS) between the two groups; progression-free survival (PFS) in the CNS (leptomeninges and brain parenchyma), clinical benefit rate (disease stability or improvement) in the CNS (leptomeninges and brain parenchyma) at 3, 6, and 12 months, overall survival rate at 6 and 12 months, LC response rate (RR) and duration of response (DoR), OS in subjects with triple-negative (HER2-/ER-/PR-) breast cancer
Safety: Determine the safety and tolerability of SNG1005.