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Article History

Received: 8 December 2020

Revised: 22 March 2021

Accepted: 22 April 2021

First Online: 22 June 2021

Ethics approval and consent to participate

: All studies were conducted in accordance with Good Clinical Practice guidelines and the provisions of the Declaration of Helsinki. The institutional review board at each participating centre reviewed the protocol and any amendments, and all patients provided written informed consent. Please see Institutional Review Board lists that approved the studies for MONALEESA-2, -3 and -7 in Supplementary Information.

: Not applicable.

: Novartis made the study protocols available for the MONALEESA-2, -3 and -7 studies at the time of primary publications in their respective journals. Individual participant data and data from this analysis will not be made available.

: H.A.B. reports consulting or advisory for AstraZeneca, Bristol-Myers Squibb, FORMA Therapeutics, Janssen, MedImmune, Mersana, Novartis, Roche/Genentech, TG Therapeutics; grants from AbbVie, Agios, AstraZeneva, Bayer, BioMed Valley Discoveries, Boehringer Ingleheim, Bristol-Myers Squibb, Celgene, Celdex, CytomX Therapeutics, eFFECTOR Therapeutics, Gilead Sciences, GlaxoSmithKline, Immunocore, Incyte, Janssen, Jounce Therapeutics, Lilly, Loxo, Macrogenics, MedImmune, Merck, Mersana, Milennium, Moderna Therapeutics, Novartis, Pfizer, PTC Therapeutics, Roche/Genentech, Seattle Genetics, Takeda, Tarveda Therapeutics, Tesaro, TG Therapeutics, Valent Technologies, Vasastern, Vertex; A.C. has nothing to disclose; A.B. reports consulting or advisory for Immunomedics, Pfizer, Novartis, Genentech/Roche, Merck, Radius Health, Spectrum Pharma, Taiho Pharma, Biothernostics Inc., Sanofi, Daichi Pharma, Puma; personal fees from Biothernostics Inc., Pfizer, Novartis, Genentech/Roche, Merck, Radius Health, Immunomedics, Spectrum Pharma, Taiho Pharma, Sanofi, Daiichi Pharma, Puma; grants from Genentech/Roche, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics, Mersana, Innocrin, Biothernostics Inc.; J.T.B. has nothing to disclose; J.S. has nothing to disclose; P.N. has nothing to disclose; D.T. reports consulting or advisory for Novartis, Pfizer, Genomic Health, GlaxoSmithKline; personal fees from Novartis, Pfizer, Genomic Health, GlaxoSmithKline; research grant from Novartis; S.-A.I. reports consulting or advisory for AstraZeneca, Novartis, Hanmi, Pfizer, Eisai, Amgen, MediPacto, Genentech/Roche, Lilly; personal fees from AstraZeneca, Novartis, Hanmi, Pfizer, Eisai, Amgen, MediPacto, Genentech/Roche, Lilly; grants from AstraZeneca, Pfizer, Genentech/Roche; S.C. reports payment to his institution from Novartis for conduct of the clinical trial during the conduct of this study; advisory board: his institution received funds for participation in clinical trials by Novartis, Pfizer, Hoffman LaRoche, Eli Lilly; he is a subject editor for the British Journal of Cancer. F.J.E. reports consulting or advisory for Novartis, Pfizer, Genentech/Roche, Celltrion Healthcare, Seattle Genetics; personal fees from Novartis, Pfizer, Genentech/Roche, Celltrion Healthcare, Seattle Genetics; grants from Novartis, Pfizer, GlaxoSmithKline, Genentech/Roche; L.H. reports consulting or advisory for Novartis; personal fees from Novartis; grants from Novartis; J.P.Z. reports employment and stock ownership from Novartis; A.R. reports employment and stock ownership from Novartis; K.R.L. reports employment and stock ownership from Novartis; D.A.Y. reports consulting or advisory for Biothernostics Inc., Bristol Myers Squibb, Celgene, Daiichi Sankyo, Lilly, Eisai, Genentech/Roche, NanoString Technologies, Novartis; personal fees from Biothernostics Inc., Bristol Myers Squibb, Celgene, Daiichi Sankyo, Lilly, Eisai, Genentech/Roche, NanoString Technologies, Novartis; grants from Daiichi Sankyo, Lilly, Eisai, Novartis, Abbvie, AstraZeneca, Clovis Oncology, Immunomedics, InventisBio, Lilly, MedImmune, Medivation, Merck, Oncothyreon, Pfizer, Syndax, Tesaro.

: These trials were funded by Novartis Pharmaceuticals Corporation. Medical writing assistance was provided by John McGuire, PhD at MediTech Media, funded by Novartis Pharmaceuticals Corporation.

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