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Patients in group B (aged\u2009&lt;\u200965\u00a0years with HRD score\u2009&lt;\u200942, or aged\u2009\u2265\u200965\u00a0years without gBRCAm) were randomized to 6 cycles of eribulin plus cyclophosphamide (group B1) or eribulin plus capecitabine (group B2); non-responders to the first 4 cycles of the eribulin-based therapy received anthracycline. Primary endpoint was pCR rate (ypT0-is, ypN0; centrally confirmed). Main secondary endpoint was safety.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The full analysis set comprised 99 patients. The pCR rate was 65% (90% CI, 46%\u201381%) and 45% (27%\u201365%) in groups A1 and A2, respectively, and 19% (8%\u201335%) in both groups B1 and B2. No major difference was seen in secondary endpoints, but peripheral neuropathy incidence was 74% in group A1, whereas it was 32%, 22%, and 26% in groups A2, B1, and B2, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>In patients aged\u2009&lt;\u200965\u00a0years with high HRD score or gBRCAm, weekly paclitaxel plus carboplatin and eribulin plus carboplatin followed by anthracycline resulted in a pCR rate of\u2009&gt;\u200960% and\u2009&gt;\u200940%, respectively, suggesting potential usefulness of patient stratification using HRD; pCR tended to be low in patients with HRD-negative tumors. Neurotoxicity was less frequent with the eribulin-based regimen. <jats:italic>Trial registration<\/jats:italic>:The study has been registered with the University Hospital Medical Information Network Clinical Trials Registry (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.umin.ac.jp\/ctr\/index-j.htm\">http:\/\/www.umin.ac.jp\/ctr\/index-j.htm<\/jats:ext-link>) with unique trial number UMIN000023162. The Japan Breast Cancer Research Group trial number is JBCRG-22.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10549-021-06184-w","type":"journal-article","created":{"date-parts":[[2021,3,25]],"date-time":"2021-03-25T03:03:35Z","timestamp":1616641415000},"page":"117-131","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Eribulin-based neoadjuvant chemotherapy for triple-negative breast cancer patients stratified by homologous recombination deficiency status: a multicenter randomized phase\u00a0II clinical trial"],"prefix":"10.1007","volume":"188","clinical-trial-number":[{"clinical-trial-number":"umin000023162","registry":"10.18810\/umin-japan"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7302-0278","authenticated-orcid":false,"given":"Norikazu","family":"Masuda","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroko","family":"Bando","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Yamanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Kadoya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigenori E.","family":"Nagai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoichiro","family":"Ohtani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoyuki","family":"Aruga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiji","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Kikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Yasojima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroi","family":"Kasai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Ishiguro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidetaka","family":"Kawabata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Morita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironori","family":"Haga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuki R.","family":"Kataoka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryuji","family":"Uozumi","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":[[2021,3,25]]},"reference":[{"issue":"11","key":"6184_CR1","doi-asserted-by":"publisher","first-page":"674","DOI":"10.1038\/nrclinonc.2016.66","volume":"13","author":"G Bianchini","year":"2016","unstructured":"Bianchini G, Baldo JM, Mayer IA, Sanders ME, Gianni L (2016) Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease. 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Dr. Bando: remuneration from AstraZeneca, Chugai, Eisai, Kyowa Kirin, Nippon Kayaku, Novartis, Pfizer, and Taiho. Dr. Yamanaka: remuneration from Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Kyowa Kirin, Novartis, and Pfizer. Dr. Kadoya: none. Dr. Takahashi: remuneration from AstraZeneca, Eisai, Eli Lilly, and Pfizer. Dr. Nagai: remuneration from Chugai, Eisai, Eli Lilly, Novartis, Pfizer, and Taiho. Dr. Ohtani: remuneration from AstraZeneca, Chugai, Eisai, Eli Lilly, and Pfizer. Dr. Aruga: remuneration from Eisai, Eisai, and Pfizer. Dr. Suzuki: none. Dr. Kikawa: remuneration from Chugai, Eisai, Eli Lilly, Novartis, Pfizer, and Taiho. Dr. Yasojima: none. Dr. Kasai: funding from Eisai during the conduct of the study; remuneration from Chugai. Dr. Ishiguro: none. Dr. Kawabata: funding from Chugai, Daiichi Sankyo, MSD, and Novartis during the conduct of the study. Dr. Morita: remuneration from AstraZeneca, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, MSD, Pfizer, and Taiho. Dr. Haga: none. Dr. Kataoka: none. Dr. Uozumi: consultant\/advisory role at CAC Croit, Eisai, and Sawai. Dr. Ohno: funding from Eisai and Taiho; remuneration from AstraZeneca, Chugai, Eisai, Eli Lilly, and Pfizer. Dr. Toi: remuneration and funding from AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Kyowa Kirin, Nippon Kayaku, Pfizer, Shimadzu, Taiho, Takeda, and Yakult; remuneration from Eli Lilly, Exact Sciences, Konica Minolta, MSD, and Novartis; funding from AFI technology, GL Sciences, JBCRG Association, Luxonus, and Shionogi; consultant\/advisory role for Athenex Oncology, Bertis, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Kansai Medical Net, Kyowa Kirin, Luxonus, and Terumo.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study complied with the Declaration of Helsinki and the Ethical Guidelines for Clinical Research of the Ministry of Health, Labour and Welfare of Japan. The study protocol was reviewed and approved by the institutional review board of each participating institution. All patients provided written informed consent at primary registration. Some of the study results were presented as a Mini Oral session at the ESMO Virtual Congress 2020.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}