[Translation] A randomized, controlled, open, multicenter, phase III clinical study comparing the efficacy and safety of KN026 combined with HB1801 in neoadjuvant treatment of early or locally advanced HER2-positive breast cancer with trastuzumab combined with pertuzumab and docetaxel
主要目的:
比较KN026联合HB1801与曲妥珠单抗联合帕妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌的tpCR(BIRC评估,AJCC第8版)
次要目的:
评价KN026联合HB1801与曲妥珠单抗联合帕妥珠单抗和多西他赛新辅助治疗早期或局部晚期HER2阳性乳腺癌tpCR(参研中心)、bpCR、ORR、EFS、iDFS 安全性
评价KN026和HB1801的药代动力学特征
评价KN026的免疫原性
[Translation] Primary purpose:
To compare the tpCR of KN026 combined with HB1801 and trastuzumab combined with pertuzumab and docetaxel in neoadjuvant treatment of early or locally advanced HER2-positive breast cancer (BIRC assessment, AJCC 8th edition)
Secondary purpose:
To evaluate the safety of tpCR (participating centers), bpCR, ORR, EFS, and iDFS of KN026 combined with HB1801 and trastuzumab combined with pertuzumab and docetaxel in neoadjuvant treatment of early or locally advanced HER2-positive breast cancer
To evaluate the pharmacokinetic characteristics of KN026 and HB1801
To evaluate the immunogenicity of KN026