{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T03:48:52Z","timestamp":1773114532151,"version":"3.50.1"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T00:00:00Z","timestamp":1696896000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T00:00:00Z","timestamp":1696896000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100004896","name":"Eisai Incorporated","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004896","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer Res Treat"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>We hypothesized that eribulin combined with cyclophosphamide (EC) would be an effective combination with tolerable toxicity for the treatment of advanced breast cancer (ABC).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients with histologically confirmed metastatic or unresectable ABC with any number of prior lines of therapy were eligible to enroll. In the dose escalation cohort, dose level 0 was defined as eribulin 1.1\u00a0mg\/m<jats:sup>2<\/jats:sup> and cyclophosphamide 600\u00a0mg\/m<jats:sup>2<\/jats:sup><jats:sub>,<\/jats:sub> and dose level 1 was defined as eribulin 1.4\u00a0mg\/m<jats:sup>2<\/jats:sup> and cyclophosphamide 600\u00a0mg\/m<jats:sup>2<\/jats:sup>. Eribulin was given on days 1 and 8 and cyclophosphamide on day 1 of a 21-day cycle. In the dose expansion cohort, enrollment was expanded at dose level 1. The primary objective was clinical benefit rate (CBR), and secondary objectives were response rate (RR), duration of response (DOR), progression-free survival (PFS), and safety.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>No dose-limiting toxicities were identified in the dose escalation cohort (n\u2009=\u20096). In the dose expansion cohort, an additional 38 patients were enrolled for a total of 44 patients, including 31 patients (70.4%) with hormone receptor-positive (HR\u2009+)\/HER2- disease, 12 patients (27.3%) with triple-negative breast cancer (TNBC), and 1 patient (2.3%) with HR\u2009+\u2009\/HER2\u2009+\u2009disease. Patients had a median age of 56\u00a0years (range 33\u201382\u00a0years), 1 prior line of hormone therapy (range 0\u20136), and 2 prior lines of chemotherapy (range 0\u20137). CBR was 79.5% (35\/44; 7 partial response, 28 stable disease) and the median DOR was 16.4\u00a0weeks (range 13.8\u201321.1\u00a0weeks). Median PFS was 16.4\u00a0weeks (95% CI: 13.8\u201321.1\u00a0weeks). The most common grade 3\/4 adverse event was neutropenia (47.7%, n\u2009=\u200921). Fourteen of 26 patients (53.8%) with circulating tumor cell (CTC) data were CTC-positive (<jats:inline-formula><jats:alternatives><jats:tex-math>$$\\ge$$<\/jats:tex-math><mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\">\n                    <mml:mo>\u2265<\/mml:mo>\n                  <\/mml:math><\/jats:alternatives><\/jats:inline-formula> 5 CTC\/7.5\u00a0mL) at baseline. Median PFS was shorter in patients who were CTC-positive vs. negative (13.1 vs 30.6\u00a0weeks, p\u2009=\u20090.011).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>In heavily pretreated patients with ABC, treatment with EC resulted in an encouraging CBR of 79.5% and PFS of 16.4\u00a0weeks, which compares favorably to single-agent eribulin. Dose reduction and delays were primarily due to neutropenia. The contribution of cyclophosphamide to eribulin remains unclear but warrants further evaluation. NCT01554371.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10549-023-07073-0","type":"journal-article","created":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T05:01:38Z","timestamp":1696914098000},"page":"197-204","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A phase Ib\/II study of eribulin in combination with cyclophosphamide in patients with advanced breast cancer"],"prefix":"10.1007","volume":"203","author":[{"given":"Ozge","family":"Gumusay","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura A.","family":"Huppert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark Jesus M.","family":"Magbanua","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara A.","family":"Wabl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Assefa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy Jo","family":"Chien","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle E.","family":"Melisko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melanie C.","family":"Majure","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Moasser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Park","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6710-4814","authenticated-orcid":false,"given":"Hope S.","family":"Rugo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,10,10]]},"reference":[{"issue":"6","key":"7073_CR1","doi-asserted-by":"publisher","first-page":"394","DOI":"10.3322\/caac.21492","volume":"68","author":"F Bray","year":"2018","unstructured":"Bray F et al (2018) Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 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Michelle E. Melisko: Research funding to institution: Astra Zeneca, Novartis, KCRN Research, Puma, Seattle Genetics. For spouse: Speaker bureau\/honoraria: AstraZeneca, Genentech, Gilead. Stock Ownership: Merrimack. John Park: Consulting\/honoraria: AstraZenica, Genentech, Diichi, Gilead. Equity\/stock ownership: Merrimack Pharma. Hope S. Rugo: Research support for clinical trials through the University of California: Pfizer, Merck, Novartis, Lilly, Roche, Daiichi, Seattle Genetics, Macrogenics, Sermonix, Boehringer Ingelheim, AstraZeneca, Astellas and Gilead. Honoraria from: Puma, Samsung, Mylan, Chugai, Blueprint, and NAPO. The remaining authors, declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}