Acknowledgments
We greatly appreciate all women who participated in this trial. We also thank all investigators and their collaborators for their dedication to this study, Mebics for their data entry assistance, and the Japan Breast Cancer Research Group (JBCRG) for their administrative assistance.
Funding
This work was supported by the Japan Breast Cancer Research Group (JBCRG), which participated in the conduction of the study, and AstraZeneca.
Competing interests
Kenichi Watanabe received personal fees from Chugai, Eli Lilly, Nippon Kayaku, Kyowa-Kirin, Novartis, Taiho, Eisai, Pfizer and Shionogi, outside the submitted work. Naoki Niikura received research funding to Tokai University from Novartis, Chugai, Daiichi Sankyo, Pfizer, Eisai, Eli Lilly and Mochida, honoraria, consultancy, and speaker fees from AstraZeneca, Novartis, Eisai, Eli Lilly, Chugai, Daiichi Sankyo, and Pfizer, outside the submitted work. Yuichiro Kikawa received consulting fee from Daiichi Sankyo, personal fees from AstraZeneca, Novartis, Taiho, Chugai, Daiichi Sankyo, Eisai and Kyowa-Kirin, outside the submitted work. Mari Oba received payment for educational lecture from AstraZeneca and Pfizer, outside the submitted work. Kokoro Kobayashi received personal fees from Pfizer, Chugai, Novartis, Taiho, Eli Lilly and AstraZeneca, outside the submitted work. Hiroshi Tada received research funding to Tohoku University from Taiho, Kyowa-Kirin and Eisai, personal fees from Chugai, Pfizer, Eli Lilly and Daiichi Sankyo, outside the submitted work. Uhi Toh received personal fees from Chugai, Eisai, Eli Lilly, Pfizer, Daiichi Sankyo and Taiho, outside the submitted work. Yutaka Yamamoto received research funding to Kumamoto University Hospital from Chugai, Kyowa-Kirin, Eisai, Daiichi Sankyo, Nippon-Kayaku, Taiho, Takeda, Eli Lilly, Pfizer and Novartis, honoraria for lectures from AstraZeneca, Chugai, Kyowa-Kirin, Novartis, Eli Lilly, Pfizer, Daiichi Sankyo, Nippon Kayaku, Taiho, Eisai, Takeda, MSD, Sysmex and Exact Science, outside the submitted work. Hiroshi Ishiguro received contract fees to Saitama Medical University International Medical Center from Eisai, speaker fees from Pfizer, outside the submitted work. Norikazu Masuda received research funding to Nagoya University Hospital from Chugai, Eli Lilly, AstraZeneca, Pfizer, Daiichi Sankyo, MSD, Eisai, Novartis, Sanofi and Kyowa-Kirin, personal fees from Chugai, Pfizer, AstraZeneca, Eli Lilly and Eisai, Representative of a board of directors of Japan Breast Cancer Research Group (JBCRG) unpaid, Board of Directors of Japanese Breast Cancer Society (JBCS) unpaid, outside the submitted work. Shigehira Saji received Grants from Eisai, Takeda and Eli Lilly, Contracted clinical trials from MSD and AstraZeneca, Grant and Contracted clinical trials from Taiho, Chugai and Daiichi Sankyo to Fukushima Medical University, personal fees from Chugai, Kyowa-Kirin, MSD, Novartis, Eisai, Takeda, Daiichi Sankyo, Eli Lilly, AstraZeneca, Pfizer, Taiho, Ono and Nippon Kayaku, personal fees for Participation on a Data Safety Monitoring Board or Advisory Board from Chugai/Roche, AstraZeneca, Eli Lilly, Pfizer, Kyowa-Kirin and Daiichi Sankyo, Executive board member of JBCRG, JBCS, Japanese Society of Medical Oncology (JSMO) and Breast International Group (BIG), outside the submitted work. The other authors have nothing to declare.
Author contributions
Kenichi Watanabe: Writing - Review & Editing, Writing - Original Draft, Conceptualization, Formal analysis
Naoki Niikura: Writing - Review & Editing, Writing - Original Draft, Conceptualization
Yuichiro Kikawa: Writing - Review & Editing, Conceptualization
Mari Oba: Writing - Review & Editing, Writing - Original Draft, Conceptualization, Formal analysis
Kokoro Kobayashi: Writing - Review & Editing, Conceptualization
Hiroshi Tada: Writing - Review & Editing
Shinji Ozaki: Writing - Review & Editing
Uhi Toh, MD: Writing - Review & Editing
Yutaka Yamamoto:Writing - Review & Editing
Michiko Tsuneizumi: Writing - Review & Editing
Toshitaka Okuno: Writing - Review & Editing
Nobutaka Iwakuma: Writing - Review & Editing, Conceptualization
Takashi Takeshita: Writing - Review & Editing, Conceptualization
Takayuki Iwamoto: Writing - Review & Editing, Conceptualization
Hiroshi Ishiguro : Writing - Review & Editing, Writing - Original Draft, Project administration, Conceptualization
Norikazu Masuda: Writing - Review & Editing, Project administration, Conceptualization, Formal analysis
Shigehira Saji: Writing - Review & Editing, Writing - Original Draft, Project administration, Conceptualization, Formal analysis
Data Availability
The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Ethics approval
This study was conducted according to the tenets of the Declaration of Helsinki and approved by the institutional review board of Fukushima medical university.
Consent to participate
All patients provided written informed consent prior to participation.
Consent to publish
Our manuscript did not contains any individual person’s data in any form (including any individual details, images or videos.