Kaufman, Peter A. http://orcid.org/0000-0003-3677-6807
Hurvitz, Sara A.
O’Shaughnessy, Joyce
Mason, Ginny
Yardley, Denise A.
Brufsky, Adam M.
Rugo, Hope S.
Cobleigh, Melody
Swain, Sandra M.
Tripathy, Debu
Morris, Anne
Antao, Vincent
Li, Haocheng
Jahanzeb, Mohammad
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Received: 23 June 2020
Accepted: 12 January 2021
First Online: 28 February 2021
Compliance with ethical standards
:
: P.A. Kaufman has received consulting fees and research funding from F. Hoffmann-La Roche/Genentech, Lilly, Celgene, Eisai, Amgen, Novartis, Macrogenics, and Puma Biotechnology. S.A. Hurvitz has received travel support from Novartis, Lilly, and OBI Pharma; and research funding from F. Hoffmann-La Roche/Genentech, Novartis, GlaxoSmithKline, Boehringer Ingelheim, Sanofi, Pfizer, Amgen, OBI Pharma, Puma Biotechnology, Dignitana, Bayer, BioMarin, Lilly, Merrimack, Daiichi-Sankyo, Immunomedics, Macrogenics, Pieris, and Seattle Genetics. J. O’Shaughnessy has received consulting fees from AbbVie Inc., Agendia, Amgen Biotechnology, AstraZeneca, Bristol-Myers Squibb, Celgene Corporation, Eisai, Genentech, Genomic Health, GRAIL, Immunomedics, Heron Therapeutics, Ipsen Biopharmaceuticals, Jounce Therapeutics, Lilly, Merck, Myriad, Novartis, Ondonate Therapeutics, Pfizer, Puma Biotechnology, Roche, Seattle Genetics, and Syndax Pharmaceuticals. G. Mason has no additional disclosures. D.A. Yardley has received consulting/advisory fees from Novartis and Genentech; and research funding from F. Hoffmann-La Roche/Genentech and Novartis. A. Brufsky has received consulting fees and travel support from F. Hoffmann-La Roche/Genentech, Novartis, Pfizer, Sandoz, AstraZeneca, Amgen, and Lilly. H.S. Rugo has received travel support from Merck, Mylan, Puma, Lilly, and Pfizer; and research funding from F. Hoffmann-La Roche/Genentech, Pfizer, Novartis, Lilly, OBI Pharma, Macrogenics, and Merck. M. Cobleigh has received consulting fees and research funding from F. Hoffmann-La Roche/Genentech. S.M. Swain has received consulting fees from AstraZeneca, Athenex, Daiichi-Sanyo, Eli Lilly and Company, F. Hoffmann-La Roche/Genentech, Genomic Health, Inivata, Ltd., Molecular Therapeutics, Novartis, Pieris Pharmaceuticals, Silverback Therapeutics, and Tocagen; research funding from F. Hoffmann-La Roche/Genentech and Kailos Genetics; non-financial support from Athenex, Daiichi-Sanyo, Eli Lilly and Company, F. Hoffmann-La Roche/Genentech, Inivata, Ltd., Novartis, Pieris Pharmaceuticals, Caris Life Sciences, AstraZeneca, Bristol-Myers Squibb; and is on an Independent Data Monitoring Committee for AstraZeneca. D. Tripathy has received consulting fees from Pfizer and Novartis, and research funding from Novartis. A. Morris was a contract employee of Genentech. V. Antao is an employee of Genentech and owns stock in F. Hoffmann-La Roche/Genentech. H. Li is an employee of F. Hoffmann-La Roche/Genentech. M. Jahanzeb has received consulting fees from F. Hoffmann-La Roche/Genentech, and served on a Scientific Advisory Board and Data and Safety Monitoring Board for Puma. All authors received non-financial support from F. Hoffmann-La Roche in the form of medical writing support for this manuscript.
: SystHERs was conducted in accordance with US Food and Drug Administration regulations, the International Conference on Harmonisation E6 Guidelines for Good Clinical Practice, the Declaration of Helsinki, and applicable local laws. Each participating site obtained approval of the study protocol by the site’s ethics committee or institutional review board (IRB), or a central IRB for sites that did not have an IRB.
: Informed consent was obtained from all individual participants included in the study.