Neven, Patrick
Rugo, Hope S.
Tolaney, Sara M.
Iwata, Hiroji
Toi, Masakazu
Goetz, Matthew P.
Kaufman, Peter A.
Lu, Yi
Haddad, Nadine
Hurt, Karla C.
Sledge, George W. Jr.
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 8 June 2021
Accepted: 4 August 2021
First Online: 23 August 2021
Declarations
:
: The study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with the International Council for Harmonization Good Clinical Practice Guidelines. All patients provided written informed consent. The final protocol, any amendments, and informed consent documentations were reviewed and approved by the Institutional Review Boards at each of the investigational centers participating in the study.
: Not applicable.
: PN declares no conflicts of interest. HSR reports research grant to her institution from Eli Lilly and Company, Pfizer, Merck, Novartis, Genentech, OBI, Odonate, Daiichi-Sankyo, Eisai, Seattle Genetics, Macrogenics, Sermonixs, Immunomedics, AstraZeneca; travel support from Daiichi- Sankyo, Mylan, Pfizer, Merck, Novartis, AstraZeneca, Macrogenics; and honoraria from Puma, Mylan, and Samsung. SMT reports research grants to her institute and personal fees (honoraria for consulting/advisory board) from Eli Lilly and Company, AstraZeneca, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Exelixis, Bristol-Myers Squibb, Eisai, Nanostring, Sanofi, Odonate, Immunomedics/Gilead; honoraria for advisory board/consulting from Puma, Celldex, Seattle Genetics, Silverback Therapeutics, G1 Therapeutics, Abbvie, Athenex, OncoPep, Kyowa Kirin Pharmaceuticals, Daiichi-Sankyo, CytomX, Samsung Bioepsis Inc., Certara, Mersana Therapeutics, OncoSec; and research funding from Cyclacel. HI reports honoraria and consulting fees from Chugai, Novartis, AstraZeneca, Pfizer, Eli Lilly and Company, Daichi-Sankyo, Eisai, Kyowa Hakko Kirin; grants from MSD, Bayer, Nihon Kayaku, Boehringer Ingelheim, Sanofi; and personal fees from Taiho. MT reports research grant and honoraria from Chugai, Takeda, Pfizer, Kyowa-Kirin, Taiho, Eisai, AstraZeneca, Daiichi-Sankyo, Shimadzu, Yakult, and Nippon Kayaku; research grant from JBCRG association, Astellas, AFI technologies, Shionogi, and GL Science; advisory role at Kyowa-Kirin, Daiichi-Sankyo, Eli Lilly and Company, Konica Minolta, Athenex Oncology, Bertis, Terumo, Luxonus, and Kansai Medical Net; honoraria from BMS, Eli Lilly and Company, MSD, Exact Science, Novartis, and Konica Minolta. He is also on the Board of Directors for DBCRG association, Organization for Oncology and Translational Research, Kyoto Breast Cancer Research Network. MPG reports consulting fees to his institution from Eagle pharmaceuticals, Biovica, Novartis, Context Therapeutics, Biotheranostics, and AstraZeneca; research grants and consulting fees to his institution from Eli Lilly and Company, Pfizer, and Sermonix. PAK reports grants from Eli Lilly and Company. YL, NH, and KCH are employees of Eli Lilly and Company. GWS reports grants and nonfinancial support from Stanford University during the conduct of the study; personal fees from Radius Pharmaceuticals and Verseau Therapeutics, grants from Pfizer, personal fees from Symphogen, personal fees and nonfinancial support from Tessa, and personal fees from Syndax outside the submitted work.