900
Participants
Start Date
April 25, 2022
Primary Completion Date
May 15, 2024
Study Completion Date
December 30, 2025
HLX11
Neoadjuvant(q3w/cycle，total 4cycle): HLX11(loading dose of 840 mg IV , followed by 420 mg IV q3w)+trastuzumab(loading dose of 8 mg/kg IV, followed by 6mg/kg IV q3w)+docetaxel(75mg/m2 IV q3w) Adjuvant: doxorubicin( 60 mg/m2 IV q3w)+cyclophosphamide( 600 mg/m2 IV q3w),total 4 cycle; trastuzumab(loading dose of 8mg/m2 IV , followed by 6 mg/m2 IV q3w)+HLX11(loading dose of 840 mg IV , followed by 420 mg IV q3w), 13cycle
EU-Perjeta®
Neoadjuvant(q3w/cycle，total 4cycle): Perjeta (loading dose of 840 mg IV , followed by 420 mg IV q3w)+trastuzumab(loading dose of 8 mg/kg IV, followed by 6mg/kg IV q3w)+docetaxel(75mg/m2 IV q3w) Adjuvant: doxorubicin( 60 mg/m2 IV q3w)+cyclophosphamide( 600 mg/m2 IV q3w),total 4 cycle; trastuzumab(loading dose of 8mg/m2 IV , followed by 6 mg/m2 IV q3w)+HLX11 or Perjeta (loading dose of 840 mg IV , followed by 420 mg IV q3w), 13cycle
Jiangsu Cancer Hospital, Nanjing
The First Affiliated Hospital With Nanjing Medical University, Nanjing
Xuzhou Central Hospital, Xuzhou
The Second Hospital of Anhui Medical University, Hefei
The first affiliated hospital of Anhui Medical University, Hefei
The first affiliated hospital of USTC (Anhui Provincial Hospital), Hefei
the First Affiliated Hospital of Bengbu Medical College, Bengbu
Lu'an people's hospital of Anhui ProvinceLuan, Lu'an
Yijishan Hospital of Wannan Medical College, Wuhu
Shandong Provincial Hospital, Jinan
Liaocheng People's Hospital, Liaocheng
Weifang People's Hospital, Weifang
he Affiliated Hospital of Qingdao University, Qingdao
Qingdao Central Hospital, Qingdao
The First Affiliated Hospital Zhejiang University School Of Medicine, Hangzhou
The Second Affiliated Hospital Zhejiang University School Of Medicine, Hangzhou
Zhejiang Provincial People's Hospital, Hangzhou
Nanchang Third Hospital, Nanchang
Fujian Cancer Hospital, Fuzhou
The First Affiliated Hospital of Xiamen University, Xiamen
Xiangya Hospital Of Central South University, Changsha
The Second Xiangya Hospital Of Central South University, Changsha
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology, Wuhan
Hubei Cancer Hospital, Wuhan
Henan Provincial People's Hospital, Zhengzhou
The First Affiliated Hospital of Zhengzhou University, Zhengzhou
Anyang Cancer Hospital, Anyang
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou
Cancer Hospital of Shantou University Medical College, Shantou
Shantou Central Hospital, Shantou
Guangxi Medical University Affiliated Tumor Hospital, Nanning
Affiliated Hospital of Zunyi Medical University, Zunyi
Sichuan Provincial People's Hospital, Chengdu
People's hospital of Deyang city, Deyang
The second people's hospital of neijiang, Neijiang
The second people's hospital of Yibin, Yibin
Yunnan Cancer Hospital, Kunming
Maanshan People's Hospital, Ma’anshan
Beijing Cancer Hospital, Beijing
Chongqing University Cancer Hospital, Chongqing
he First Affiliated Hospital of Chongqing Medical University, Chongqi
Sun Yat-Sun Yat-sen Hospital affiliated to Sun Yat-sen Universitysen Hospital affiliated to Sun Yat-sen University, Guanzhou
Jieyang People's Hospital, Jieyang
Meizhou People's Hospital, Meizhou
Yue Bei People's Hospital, Shaoguan
Affiliated Hospital of Guangdong Medical University, Zhanjiang
Zhongshan People's Hospital, Zhongshan
Affiliated Hospital of Guizhou Medical University, Guiyang
Affiliated Tumor Hospital of Guizhou Medical University, Guiyang
Affiliated Hospital of Hebei University, Baoding
Cangzhou Central Hospital, Cangzhou
Tangshan People's Hospital, Tangshan
Harbin Medical University Cancer Hospital, Harbin
The First Affiliated Hospital of Henan University of science and Technology, Luoyang
Nanyang Central Hospital, Nanyang
The First Affiliated Hospital of the Xinxiang Medical University, Xinxiang
Xinxiang Central Hospital, Xinxiang
The Third Affiliated Hospital of Zhengzhou University, Zhengzhou
Hunan Cancer Hospital, Changsha
Nanjing Drum Tower Hospital, Nanjing
Nantong Tumor Hospital, Nantong
affiliated Hospital of Jiangnan University, Wuxi
The first hospital of Jilin University, Changchun
The second hospital of dalian medical university, Dalian
Liaoning Cancer Hospital & Institute, Shenyang
Weifang Hospital of traditional Chinese Medicine, Weifang
Weihai Municipal Hospital, Weihai
Yantai Yuhuangding Hospital, Yantai
Shanxi Cancer Hospital, Taiyuan
The First Affiliated Hospital of Xi'an JiaoTong University, Xian
Shaanxi Provincial People's Hospital, Xi’an
Yuncheng Central Hospital, Yuncheng
Mianyang Central Hospital, Mianyang
Tianjin Medical University Cancer Institute & Hospital, Tianjin
The First Affiliated Hospital of Kunming Medical University, Kunming
University of Pécs, Department of Oncotherapy, Pécs
Instytut Centrum Zdrowia Matki Polki, Lodz
Hospital Clínico Universitario de Santiago de Compostela (CHUS), Santiago de Compostela
Hospital Arnau de Vilanova de Lleida, Barcelona
Shanghai Henlius Biotech
INDUSTRY