[Translation] A randomized, open-label, parallel-controlled, multicenter phase III clinical study evaluating TQB2930 combined with chemotherapy selected by the investigator versus trastuzumab combined with chemotherapy selected by the investigator in the treatment of HER2-positive advanced breast cancer
主要目的:通过独立影像评审委员会(IRC)评估的无进展生存期(PFS)证明TQB2930联合研究者选择的化疗对比曲妥珠单抗联合研究者选择的化疗在晚期阶段接受过至少2线抗HER2治疗的的HER2阳性晚期乳腺癌受试者中的有效性。
次要目的:
通过研究者评估的PFS,研究者及IRC评估的缓解持续时间(DOR)、客观缓解率(ORR)、疾病控制率(DCR)、临床获益率(CBR),总生存期(OS)证明TQB2930联合研究者选择的化疗对比曲妥珠单抗联合研究者选择的化疗在晚期阶段接受过至少2线抗HER2治疗的的HER2阳性晚期乳腺癌受试者中的有效性。
评价TQB2930联合研究者选择的化疗对比曲妥珠单抗联合研究者选择的化疗在晚期阶段接受过至少2线抗HER2治疗的的HER2阳性晚期乳腺癌受试者中的安全性 。
评价TQB2930联合研究者选择的化疗在晚期阶段接受过至少2线抗HER2治疗的HER2阳性晚期乳腺癌受试者中的群体药代动力学(PK)特征。
评价TQB2930联合研究者选择的化疗在晚期阶段接受过至少2线抗HER2治疗的HER2阳性晚期乳腺癌受试者中的免疫原性。
[Translation] Primary objective: To demonstrate the efficacy of TQB2930 combined with chemotherapy selected by the investigator versus trastuzumab combined with chemotherapy selected by the investigator in subjects with HER2-positive advanced breast cancer who have received at least 2 lines of anti-HER2 therapy at the advanced stage through progression-free survival (PFS) assessed by an independent imaging review committee (IRC).
Secondary objectives:
To demonstrate the efficacy of TQB2930 combined with chemotherapy selected by the investigator versus trastuzumab combined with chemotherapy selected by the investigator in subjects with HER2-positive advanced breast cancer who have received at least 2 lines of anti-HER2 therapy at the advanced stage through PFS assessed by the investigator, duration of response (DOR) assessed by the investigator and IRC, objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), and overall survival (OS).
To evaluate the safety of TQB2930 combined with chemotherapy selected by the investigator versus trastuzumab combined with chemotherapy selected by the investigator in subjects with HER2-positive advanced breast cancer who have received at least 2 lines of anti-HER2 therapy at the advanced stage.
To evaluate the population pharmacokinetic (PK) characteristics of TQB2930 in combination with chemotherapy selected by the investigator in subjects with HER2-positive advanced breast cancer who have received at least 2 lines of anti-HER2 therapy in the advanced stage.
To evaluate the immunogenicity of TQB2930 in combination with chemotherapy selected by the investigator in subjects with HER2-positive advanced breast cancer who have received at least 2 lines of anti-HER2 therapy in the advanced stage.