Li, Rubi K. http://orcid.org/0000-0002-2646-0932
Tokunaga, Eriko
Adamchuk, Hryhoriy
Vladimirov, Vladimir
Yanez, Eduardo
Lee, Keun Seok
Bondarenko, Igor
Vana, Alicia
Hilton, Fiona
Ishikawa, Tomofumi
Tajima, Kentaro
Lipatov, Oleg
Clinical trials referenced in this document:
Documents that mention this clinical trial
Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study
https://doi.org/10.1007/s40259-021-00513-7
Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer
https://doi.org/10.1007/s00280-019-03850-1
Funding for this research was provided by:
Pfizer
Article History
Accepted: 10 December 2021
First Online: 8 February 2022
Declarations
:
: This study was sponsored by Pfizer.
: Rubi K. Li received personal fees for giving lectures and being an advisory member from Pfizer Inc., Roche, Eli Lilly, Hi-Eisai, Novartis, AstraZeneca, and MSD. Eriko Tokunaga received fees from Chugai, AstraZeneca, and Eli Lilly. Hryhoriy Adamchuk, Vladimir Vladimirov, Eduardo Yanez, Igor Bondarenko, and Oleg Lipatov have no conflicts of interest to declare. Keun Seok Lee reports personal fees from Roche, Lilly, Novartis, Daiichi Sankyo, MSD, and Pfizer; and drug support from Dong-A ST, outside the submitted work. Fiona Hilton, Alicia Vana, and Tomofumi Ishikawa are employees of and have stock and/or other ownership interests in Pfizer. Kentaro Tajima is an employee of Pfizer Japan Inc.
: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See ExternalRef removed for more information.
: Not applicable.
: All authors had full access to all study data. All authors made important contributions to data acquisition, analysis, and/or interpretation of data. All authors reviewed manuscript drafts and have reviewed and approved the final version for submission.
: This study was conducted in compliance with the ethical principles originating in, or derived from, the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines, and was reviewed and approved by institutional review boards and/or independent ethics committees. All local regulatory requirements were followed, particularly those affording greater protection to the safety of trial participants. The study was sponsored by Pfizer and is registered on ClinicalTrials.gov (Identifier: NCT01989676) and EudraCT (EudraCT Number: 2013-001352-34).
: All patients provided informed consent before undergoing any study-specific procedures.
: Not applicable.