[Translation] A phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3912 tablets combined with fulvestrant injection ± TQB3616 capsules in subjects with locally advanced or metastatic HR-positive, HER2-negative breast cancer
主要目的 队列2的Ib期:评估TQB3912片联合氟维司群注射液和TQB3616胶囊治疗局部晚期或转移性HR阳性、HER2阴性乳腺癌受试者的最大耐受剂量和II期推荐剂量(RP2D)。
队列1,队列2的II期:本研究旨在证明局部晚期或转移性HR阳性、HER2阴性乳腺癌受试者中,TQB3912片联合氟维司群注射液±TQB3616胶囊能够改善受试者的客观缓解率(ORR)。 次要目的 通过评估PFS、DOR、DCR、CBR、OS等证明TQB3912片联合氟维司群注射液±TQB3616胶囊在局部晚期或转移性HR阳性、HER2阴性乳腺癌受试者中的有效性。
TQB3912片联合氟维司群注射液±TQB3616胶囊在局部晚期或转移性HR阳性、HER2阴性乳腺癌受试者中的安全性
TQB3912片联合氟维司群注射液±TQB3616胶囊在局部晚期或转移性HR阳性、HER2阴性乳腺癌受试者中的药代动力学(PK)特征。
[Translation] Primary objective Phase Ib of cohort 2: To evaluate the maximum tolerated dose and phase II recommended dose (RP2D) of TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules in the treatment of subjects with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
Phase II of cohort 1 and cohort 2: This study aims to prove that TQB3912 tablets combined with fulvestrant injection ± TQB3616 capsules can improve the objective response rate (ORR) of subjects with locally advanced or metastatic HR-positive, HER2-negative breast cancer. Secondary objective To prove the effectiveness of TQB3912 tablets combined with fulvestrant injection ± TQB3616 capsules in subjects with locally advanced or metastatic HR-positive, HER2-negative breast cancer by evaluating PFS, DOR, DCR, CBR, OS, etc.
Safety of TQB3912 tablets combined with fulvestrant injection ± TQB3616 capsules in subjects with locally advanced or metastatic HR-positive, HER2-negative breast cancer
Pharmacokinetic (PK) characteristics of TQB3912 tablets combined with fulvestrant injection ± TQB3616 capsules in subjects with locally advanced or metastatic HR-positive, HER2-negative breast cancer.