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The study was registered on ClinicalTrials.gov (NCT03264547; registered: 28 June 2017) and the University Hospital Medical Information Network (UMIN000027938; registered: 26 June 2017). The study was conducted in adherence to the Declaration of Helsinki and relevant ethical guidelines. It was approved by the ethics committee at each institution.","order":1,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All patients provided written informed consent to participate in the JBCRG-M06\/EMERALD study. Additional consent for data to be collected from their medical records and included in the present analysis was considered unnecessary, since no further interventions were involved.","order":2,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Consent to publish","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"NM reports receiving grants (institution) from Chugai Pharmaceutical, Eli Lilly, AstraZeneca, Pfizer, Daiichi Sankyo, MSD, Eisai, Novartis, Gilead Sciences, and Ono Pharmaceutical; receiving honoraria (personal) from Chugai Pharmaceutical, Pfizer, AstraZeneca, Eli Lilly, Daiichi Sankyo, Eisai, Gilead Sciences, and MSD; serving as a representative (unpaid, 2021\u20122025) and a member of the board of directors (unpaid, 2007\u2012current) for Japan Breast Cancer Research Group (JBCRG), a member of the board of directors (unpaid, 2021\u20122024) for Japanese Breast Cancer Society (JBCS), a member of the board of directors (unpaid, 2023\u20122025) for Japan Society of Clinical Oncology (JSCO), a member of the board of directors (unpaid, 2024\u2012current) for Japan Association of Breast Cancer Screening (JABCS), and a representative of the board of directors (unpaid, 2025\u2012current) for Kyoto Breast Cancer Research Network (KBCRN). SS reports receiving grants (institution) from Taiho Pharmaceutical, Eisai, and Takeda Pharmaceutical; grants and contracted clinical trials (institution) from Chugai Pharmaceutical and Daiichi Sankyo; contracted clinical trials (institution) for MSD, AstraZeneca, Gilead Sciences, Eli Lilly and Sanofi; receiving honoraria (personal) from Chugai Pharmaceutical, Kyowa Kirin, MSD, Novartis Pharma, Eisai, Takeda Pharmaceutical, Daiichi Sankyo, Eli Lilly, AstraZeneca, Pfizer, Taiho Pharmaceutical, Ono Pharmaceutical, Nippon Kayaku, Gilead Sciences and Exact Sciences; participation in data safety monitoring board or advisory board (personal) for Chugai\/Roche, AstraZeneca, Eli Lilly, Pfizer, Kyowa Kirin, Daiichi Sankyo and MSD; serving as an executive board member for JBCRG, and JBCS. Y Kojima reports receiving honoraria (personal) from Daiichi Sankyo, AstraZeneca, Kyowa Kirin, Chugai Pharmaceutical, Eisai, Exact Sciences, MSD, and Taiho Pharmaceutical. HT reports receiving honoraria (personal) from Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly, AstraZeneca, and Pfizer. KK reports receiving honoraria (personal) from Chugai Pharmaceutical, Pfizer, and Daiichi Sankyo. T Iwatani reports receiving honoraria for lecture (personal) from Eisai, and Eli Lilly. YS reports receiving honoraria for lecture (personal) from Pfizer, Daiichi Sankyo, Eli Lilly, MSD, Kyowa Kirin, AstraZeneca, Eisai, Chugai Pharmaceutical, Nippon Kayaku, and Sysmex. MS reports receiving honoraria (personal) from AstraZeneca, Eli Lilly, Gilead Sciences, Chugai Pharmaceutical, Daiichi Sankyo, Pfizer, and MSD. AS reports receiving grants (institution) from Chugai Pharmaceutical, AstraZeneca, Eisai, Pfizer, Gilead Sciences, MSD, and Daiichi Sankyo; receiving honoraria for lecture (personal) from AstraZeneca, Pfizer, MSD, Nihon Medi-Physics, Exact Sciences, Daiichi Sankyo, Eli Lilly, Chugai Pharmaceutical, and Taiho Pharmaceutical. T Yamaguchi reports receiving consulting fee (personal) from Eisai. HH and SO report full-time employment with Eisai and personal stock ownership in the company. SM reports receiving honoraria (personal) from AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, and Ono Pharmaceutical. T Yamashita reports receiving grants (institution) from Chugai Pharmaceutical, Nippon Kayaku, Daiichi Sankyo, Eli Lilly, AstraZeneca, Pfizer, Seagen, MSD, Ono Pharmaceutical, Gilead Sciences and Eisai; receiving honoraria for lecture (personal) from Chugai Pharmaceutical, Eisai, AstraZeneca, Kyowa Kirin, Pfizer, Taiho Pharmaceutical, Eli Lilly, Daiichi Sankyo, MSD, Gilead Sciences, and Exact Sciences. The authors received support from Eisai for medical writing and article processing charges associated with this manuscript. Otherwise, the following authors declare no conflicts of interest related to this work: MK, T Iwasa, TK, TS, KT, and Y Kawaguchi.","order":4,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"3"}}