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All patients received adjuvant or first-line chemotherapy with trastuzumab and a taxane. The treatment comprised eribulin on days 1 and 8 of a 21-day\u00a0cycle and trastuzumabplus pertuzumab once every 3\u00a0weeks, all administered intravenously. While the primary endpoint was the progression-free survival (PFS), secondary endpoints were the response rate and safety. <jats:italic>Results<\/jats:italic> Of 50 patients, 49 were eligible for safety analysis, and the full analysis set (FAS) included 46 patients. We treated 8 (16%) and 41 (84%) patients in first- and second-line settings, respectively. While 11 patients (23.9%) had advanced disease, 35 (76.1%) had metastatic disease. The median PFS was 9.2\u00a0months for all patients [95% confidence interval (CI): 7.0\u201311.4]. In the FAS, 44 patients had the measurable lesions and the complete response rate (CR) was 17.4%, and partial response rate (PR) was 43.5%. The grade 3\/4 adverse events were neutropenia (5 patients, 10.2%), including febrile neutropenia (2 patients, 4.1%), hypertension (3 patients, 6.1%), and other (1 patient). The average of the left ventricular ejection fraction did not decline markedly. No symptomatic left ventricular systolic dysfunction was observed. <jats:italic>Conclusions<\/jats:italic> In patients with HER2-positive AMBC, eribulin, pertuzumab, and trastuzumab combination therapy exhibited substantial antitumor activity with an acceptable safety profile. Hence, we have started a randomized phase III study comparing eribulin and a taxane in combination with pertuzumab and trastuzumab for the treatment of HER2-positive AMBC. <jats:bold>Trial registration ID:<\/jats:bold> UMIN-CTR: UMIN000012232.<\/jats:p>","DOI":"10.1007\/s10637-020-00991-6","type":"journal-article","created":{"date-parts":[[2020,8,24]],"date-time":"2020-08-24T09:02:52Z","timestamp":1598259772000},"page":"217-225","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy of the eribulin, pertuzumab, and trastuzumab combination therapy for human epidermal growth factor receptor 2\u2013positive advanced or metastatic breast cancer: a multicenter, single arm, phase II study (JBCRG-M03 study)"],"prefix":"10.1007","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6479-1660","authenticated-orcid":false,"given":"Toshinari","family":"Yamashita","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidetoshi","family":"Kawaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norikazu","family":"Masuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Kitada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazutaka","family":"Narui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaya","family":"Hattori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuhiro","family":"Yoshinami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuki","family":"Matsunami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Yanagihara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teru","family":"Kawasoe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Nagashima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroko","family":"Bando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Yano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshie","family":"Hasegawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rikiya","family":"Nakamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Kashiwaba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Morita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinji","family":"Ohno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Toi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,8,24]]},"reference":[{"key":"991_CR1","doi-asserted-by":"publisher","first-page":"3997","DOI":"10.1200\/JCO.2013.50.9984","volume":"31","author":"AC Wolff","year":"2013","unstructured":"Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF, American Society of Clinical Oncology, College of American Pathologists (2013) Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology\/College of American Pathologists clinical practice guideline update. 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Yamashita has received honoraria from Chugai, Eisai, Novartis, Nippon Kayaku, Taiho, AstraZeneca, Kyowa Kirin, Pfizer, and Eli Lilly; funding from Chugai, Taiho, Kyowa Kirin, and Nippon Kayaku. H. Kawaguchi has received honoraria from Chugai, AstraZeneca. Eisai, Kvowa Kirin. Novartis, Taiho, Pfizer, Eli Lilly, and Takeda; and consulting fee from AstraZeneca, Chugai, Eisai, and Pfizer. Norikazu Masuda has received honoraria from Chugai, AstraZeneca, Pfizer, Eli Lilly, Eisai, and Takeda; funding from Chugai, AstraZeneca, Kyowa Hakko Kirin, MSD, Novartis, Pfizer, Eli Lilly, Eisai, and Daiichi Sankyo. Tetsuhiro Yoshinami and M. Kashiwaba has received honoraria from Chugai. S. Morita has received honoraria from AstraZeneca, Bristol-Myers Squibb Company, Chugai, Eisai, Eli Lilly, MSD, Pfizer, Taiho. S Ohno received honoraria from Chugai, AstraZeneca, Taiho, Pfizer, Novartis, and Kyowa Kirin; funding from Taiho and Eisai. M Toi received honoraria for lecture from Eisai, Chugai, Daiichi Sankyo, Kyowa Kirin, Konica-Minolta, AstraZeneca, MSD, Pfizer, Eli Lilly, Novartis, Taiho, and Takeda; consulting fee from Kyowa Kirin, Daiichi Sankyo; and funding from Eisai, AstraZeneca, Taiho, Shimadzu, Astellas, AFI, Chugai, GL Science, Nippon Kayaku, Kyowa Kirin, and Shionogi. MK, KN, M.H, NM, KY, TK, TN, HB, HY, YH, and RN do not have any conflicts of interest to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The experiments in this study comply with the current laws of the country in which they were performed.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"We obtained informed consent from all participants in this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. This study was reviewed and approved by each institution\u2019s review board and\/or ethics committee<b>.<\/b>","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants and\/or animals"}}]}}