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Article History

Received: 15 March 2021

Accepted: 5 November 2021

First Online: 24 November 2021

Declarations

:

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board at each participating site (National Cancer Center Japan [approval number T4254], Aichi Cancer Center Central Hospital [approval number 27–42], and National Hospital Organization Osaka National Hospital [approval number 2015–0010]) and were conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual participants included in the study.

: Not applicable.

: This study was supported by Kyowa Kirin Co., Ltd., who was involved in the study design, data collection, data analysis, and preparation of the manuscript. NM reports grants from Kyowa Kirin, during the conduct of the study; grants and/or personal fees from Chugai, AstraZeneca, Kyowa Kirin, MSD, Novartis, Pfizer, Eli Lilly, Eisai, Nihon Kayaku, and Daiichi Sankyo, outside the submitted work; and board membership of the Japanese Breast Cancer Society and the Japan Breast Cancer Research Group Association. KT reports grants and non-financial support from Kyowa Kirin, during the conduct of the study; grants, personal fees, and/or non-financial support from Pfizer, Daiichi Sankyo, Chugai, Eli Lilly, AstraZeneca, and MSD, outside the submitted work. AS reports grants and/or personal fees from Chugai, AstraZeneca, Pfizer, Eli Lilly, Eisai, Daiichi Sankyo, Novartis, Mochida, Kyowa Kirin, Taiho, and MSD, outside the submitted work. RK is an employee of Kyowa Kirin. YN is an employee of Kyowa Kirin. SS reports personal fees from Kyowa Kirin, during the conduct of the study; and grants and/or personal fees from Chugai, Kyowa Kirin, Eli Lilly, AstraZeneca, Pfizer, MSD, Novartis, Eisai, Takeda, and Taiho, outside the submitted work. HI reports grants, personal fees, and non-financial support from Kyowa Kirin, during the conduct of the study; and grants and/or personal fees from Chugai, Pfizer, Eli Lilly, AstraZeneca, Taiho, Novartis, Daiichi Sankyo, MSD, Eisai, Bayer, and GSK, outside the submitted work. The other authors declare that they have no competing interests.