Xu, Binghe
Zhang, Qingyuan
Sun, Tao
Li, Wei
Teng, Yue’e
Hu, Xichun
Bondarenko, Igor
Adamchuk, Hryhoriy
Zhang, Liangming
Trukhin, Dmytro
Wang, Shusen
Zheng, Hong
Tong, Zhongsheng
Shparyk, Yaroslav
Wang, Qingyu
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial
https://doi.org/10.1007/s40259-021-00475-w
Funding for this research was provided by:
Shanghai Henlius Biotech, Inc.
Article History
Accepted: 6 March 2021
First Online: 7 April 2021
Declarations
:
: This study was funded by Shanghai Henlius Biotech, Inc.
: Qingyu Wang is an employee of Henlius. Binghe Xu, Qingyuan Zhang, Tao Sun, Wei Li, Yue’e Teng, Xichun Hu, Igor Bondarenko, Hryhoriy Adamchuk, Liangming Zhang, Dmytro Trukhin, Shusen Wang, Hong Zheng, Zhongsheng Tong, and Yaroslav Shparyk have no conflicts of interest that are directly relevant to the content of this article.
: The trial was conducted in accordance with the principles of both good clinical practice from the International Conference on Harmonization and the 1964 Declaration of Helsinki. The protocol and all amendments of this study were approved by regulatory authorities and the ethics committees of all participating centers (Table InternalRef removed in the ESM). This study was approved by the National Medical Products Administration (China); the Food and Drug Administration (Philippines); the Ministry of Health (Ukraine); and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Poland).
: All participants provided written informed consent before admission and initiation of the study.
: Not applicable.
: Data are available from the corresponding authors upon reasonable request.
: Not applicable.
: BX contributed to the study design and conception. QZ, TS, WL, YT, XH, IB, HA, LZ, DT, SW, HZ, ZT, YS, QW, and the other HLX02-BC01 investigators contributed to the data collection and analysis. All authors contributed to the data analysis, interpretation, and manuscript writing and editing. All authors reviewed and approved the final manuscript.