Document is current

Article History

Received: 22 October 2018

Accepted: 25 March 2019

First Online: 11 April 2019

Compliance with ethical standards

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: All authors received support for third-party writing assistance for this manuscript, provided by F. Hoffmann-La Roche Ltd. W.P.K. and A.G. are paid employees of Genentech, Inc., significant stockholders for Roche Holding Ltd, and inventors on a pertuzumab-related patent filing. M.K., B.W., I.N., S.M., and S.G. are paid employees of Genentech, Inc. and significant stockholders for Roche Holding Ltd. L.L. is a paid employee of, and has a significant ownership in, qPharmetra LLC. A.K. is a paid employee of Roche Products Limited and a significant stockholder for Roche Holding Ltd. R.Ma. was a paid employee of Roche Products Limited at the time of the study. D.F. received funding to run the conduct clinical trials from F. Hoffmann-La Roche Ltd/Genentech, Inc., AstraZeneca, Novartis, Servier, Tesaro, Pfizer, and GlaxoSmithKline, paid to her institution, and research grants from the charitable organizations BCRF, Foundation Cancer Luxembourg, and the Belgian National Lottery, paid to her institution. R.Mc. received funding to assist in the running of the APHINITY study from F. Hoffmann-La Roche Ltd, paid to his institution. G.J. has received honoraria from Novartis, Roche, Lilly, Pfizer, Amgen, and Bristol-Myers Squibb; holds a consulting/advisory role for Novartis, Celgene, Roche, Amgen, Pfizer, Bristol-Myers Squibb, Lilly, Puma Biotechnology, AstraZeneca, Daiichi Sankyo, and AbbVie; and has received research funding from Novartis and Roche. C.T. has received honoraria from Daiichi Sankyo, Roche, Pfizer, and Eisai, and travel expenses from MSD and Daiichi Sankyo. J.Ba. holds leadership positions in Varian Medical Systems, Bristol-Myers Squibb, Foghorn, Grail, Aura, and Infinity; consulting/advisory roles for Grail, PMV Pharma, ApoGen, Juno Therapeutics, Roche/Genentech, Lilly, Novartis, and Northern Biologics; stock or other ownership in PMV Pharma, Grail, Tango, Venthera, Juno, Varian, Foghorn, Aura, Infinity, ApoGen; and has received honoraria, travel, accommodations, and expenses from Roche/Genentech, Novartis, Lilly. G.v.M. has received research funding from Pfizer, Amgen, Celgene, AstraZeneca, Myriad Genetics, AbbVie, Vifor, and Roche, to his institution. J. Bi. has received clinical study funding from Roche as PI of the study; travel expenses to medical meetings from AstraZeneca and Roche; and holds consulting roles (advisory boards) with AbbVie, AstraZeneca, Genomic Health, Libbs, Pfizer, and Roche. C.F. declares no other conflict of interest.

: The study was conducted in full accordance with the guidance of Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol was approved by the institutional review board at each participating site. All participants provided written informed consent.

: Qualified researchers may request access to individual patient level data through the clinical study data request platform (ExternalRef removed) after 31 July 2020. Before this date, qualified researchers may request access to individual patient level data by submitting, within a call for proposals, a Research Proposal to BIG. Further details on Roche's criteria for eligible studies are available here (ExternalRef removed). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (ExternalRef removed).