Acknowledgments:
We thank all the patients who participated in the POTENT trial and the investigators and research coordinators at the 139 participating institutions. We thank Dr. Yasuo Ohashi, a former professor at Chuo University (March 2021), for his valuable advice during the study and contributions to the study concept and design, data acquisition, analysis and interpretation.
Funding information:
This work was organized by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation (PHRF) and supported by Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical Co., Ltd. provided the research funding to the PHRF for drug and research expenditures under the study contract. Taiho Pharmaceutical Co., Ltd. provided information relevant to the proper use of the study drug but played no role in the design of the study; collection, analysis, and interpretation of the data; writing of the manuscript; and decision to submit the manuscript for publication.
Competing interests:
MTa received grants from Taiho (Tokyo, Japan) during the conduct of the study and has received grants from AstraZeneca (Osaka, Japan), Daiichi Sankyo (Tokyo, Japan), Eisai (Tokyo, Japan), Yakult (Tokyo, Japan), Medbis (Kyoto, Japan), the Japan Breast Cancer Research Group Association (JBCRG), the Kyoto Breast Cancer Research Network (KBCRN), ABCSG, and IQVIA Japan; and personal fees from Chugai (Tokyo, Japan), AstraZeneca, Daiichi Sankyo, Taiho, Pfizer (Tokyo, Japan), Eli Lilly (Kobe, Japan), Eisai, and MSD (Tokyo, Japan). HIw has received consulting fees from Daiichi Sankyo, Chugai, Lilly, AstraZeneca, Pfizer, MSD, and Novartis; and received personal fees from Daiichi Sankyo, Chugai, AstraZeneca, Lilly, MSD, Pfizer, and Taiho. NM has received grants from Chugai, AstraZeneca, MSD, Pfizer, Eli Lilly, Kyowa Kirin, Eisai, Novartis, Sanofi (Tokyo, Japan), Daiichi Sankyo, and Nippon Kayaku; and personal fees from Chugai, AstraZeneca, Pfizer, Elli Lilly, Eisai, and Takeda. NM is also a member of the board of directors of the Japan Breast Cancer Society (JBCS) and JBCRG. HM has received grants from Daiichi Sankyo, and Eisai; and personal fees from Taiho, Daiichi Sankyo, and Takeda. SS has received grants from AstraZeneca, Chugai, Daiichi Sankyo, MSD, and Taiho; and personal fees from AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Kyowa Kirin, MSD, Novartis, Ono (Osaka, Japan), Pfizer, Taiho, and Takeda. SS also received advisory fees from AstraZeneca, Chugai, Daiichi Sankyo, MSD, and Pfizer. TSa has received grants from Maruho, LabCorp Japan, Sanofi, Takeda, Novartis, MSD, Sawai, Covance Japan, Taiho, WJOG, Chugai, Nippon Kayaku, AstraZeneca, Eisai, Kyowa Kirin, Daiichi Sankyo, and Eli Lilly; and personal fees from Ono, Kyowa Kirin, Chugai, ASKA, Novartis, AstraZeneca, Eisai, Taiho, Takeda, Eli Lilly, Pfizer, MiRTeL, and Meiji Seika. KA has received personal fees from Chugai, Eisai, AstraZeneca, Taiho, Daiichi Sankyo, Pfizer, and Eli Lilly; and research grant from Chugai, Eisai, and Takeda. TSu has received research grants from Chugai, Eisai, and Kyoto Bridge. For Breakthrough Medicine (KBBM); and personal fees from Chugai, MSD, AstraZeneca, Pfizer, Eli Lillym Taiho, Daiichi Sankyo, and Eisai. TU has received personal fees from Chugai, Eisai, AstraZeneca, and Novartis; and research grant from Eli lilly. SO has received personal fees from Chugai, MSD, Eli Lilly, and Nippon Kayaku. HI has received personal fees from JMS, Eisai, Pfizer, Chugai, Kyowa Kirin, and Daiichi Sankyo; and research grant from Eisai, Daiichi Sankyo, Chugai, Nipro, and Takeda. MTo received grants from Taiho during the conduct of the study and has received grants from Chugai, Takeda, Pfizer, Taiho, JBCRG, KBCRN, Eisai, Eli Lilly, Daiichi Sankyo, AstraZeneca, Astellas (Tokyo, Japan), Shimadzu (Kyoto, Japan), Yakult, Nippon Kayaku, AFI technology, Luxonus (Kawasaki, Japan), Shionogi, GL Science, and Sanwa Shurui; personal fees from Chugai, Takeda, Pfizer, Kyowa Kirin, Taiho, Eisai, Daiichi Sankyo, AstraZeneca, Eli Lilly, MSD, Exact Science (Tokyo, Japan), Novartis, Shimadzu, Yakult, Nippon Kayaku, Devicore and Sysmex; and advisory fees from Daiichi Sankyo, Eli Lilly, BMS (Tokyo, Japan), Athenex Oncology, Bertis, Terumo (Tokyo, Japan), and Kansai Medical Net. MTo is also a member of the board of directors of JBCRG, KBCRN, and Organisation for Oncology and Translational Research. The other authors declare no other potential conflicts of interest.
Authors’ contributions:
Conceptualization: MTa, SI, TIs, YI, HIw, NM, HM, SS, TIk, HH, TS, KA, TS, TU, SO, HIs, CK, TM, and MTo; Methodology: MTa, YH, and MTo; Formal analysis and investigation: MTa and MTo; Writing – original draft: MTa and MTo; Writing – review & editing: MTa, SI, TIs, YI, HIw, NM, HM, SS, TIk, HH, TS, KA, TS, TU, SO, HIs, CK, TM, YH, and MTo. All authors approved the final version of the manuscript for submission.
Data availability:
The data on which this article is based will be made available if a reasonable request is made to the corresponding author. Requests for data access should be made in writing and be addressed to the corresponding author, including details of how the data will be used. Sharing of data will be considered based on scientific merit, feasibility, and timeliness of the request.
Ethics approval and consent to participate:
The trial protocol was approved by the institutional review board of each study site. This study was conducted in accordance with the provisions of the Declaration of Helsinki and its later amendments. Written informed consent was obtained from all patients.
Consent for publication:
Not applicable.