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The randomized phase II OPERA study investigated the efficacy and safety of DHP107 versus IV paclitaxel in patients with HER2-negative breast cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      OPERA was conducted in the USA and Czech Republic. Patients were\u2009\u2265\u200918\u00a0years, with measurable disease, and histologically or cytologically confirmed recurrent or metastatic breast cancer with any tumor hormone receptor status. Patients were randomized 2:1 to DHP107 (200\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      po bid with premedication if needed on days 1, 8, and 15, every 28\u00a0days) or IV paclitaxel (80\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      with standard premedication on days 1, 8, and 15 every 28\u00a0days). The primary objective was DHP107 efficacy; secondary objectives included DHP107 safety and tolerability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      72 patients were randomized, 48 to DHP107 and 24 to IV paclitaxel. There was one complete response and 11 partial responses with DHP107 (objective response rate [ORR 25.0%; 90% CI 15.1\u201337.3), and six partial responses with IV paclitaxel (objective response rate [ORR] 28.6%; 90% CI 13.2\u201348.7;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.7559). Median progression-free survival (PFS) was 5.5\u00a0months for DHP107 and 4.7\u00a0months for IV paclitaxel (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.8018); median overall survival (OS) was 17.1 and 13.2\u00a0months, respectively (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.7629). Common all-grade adverse events were diarrhea (68.8%), nausea (64.6%), and fatigue (52.1%) for DHP107 and fatigue (47.6%), peripheral neuropathy (42.9%), and alopecia (42.9%) for IV paclitaxel.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>DHP107 is a tolerable and feasible treatment for patients with recurrent or metastatic HER2-negative breast cancer, with similar efficacy and safety to IV paclitaxel.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Clinicaltrials.gov no:<\/jats:bold>\n                      NCT03326102; date of registration October 19, 2017.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10549-026-07944-2","type":"journal-article","created":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T04:36:09Z","timestamp":1774845369000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer"],"prefix":"10.1007","volume":"217","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6710-4814","authenticated-orcid":false,"given":"Hope S.","family":"Rugo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. 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Hoffman-La Roche\/Genentech, StemlineTherapeutics, and Ambryx to prior institution (UCSF), and from Bicycle Therapeutics, F. Hoffman-La Roche\/Genentech, and Stemline Therapeutics to current institution (City of Hope) and received consulting fees from Napo, Bristol Myers Squibb, Helsinn, and\u00a0BioNTech. NV received grants or contracts for research funding to institution (MGH) from Merck, Daehwa, Pfizer, Radius, Novartis, Stemline, and\u00a0Ellipses; consulting fees for advisory board participation (all ended) from AbbVie, OncoSec, Aadi, Gilead, TerSera, Novartis, Pfizer, and\u00a0IDEOlogy Health; and participated in steering committees for Celucity\u00a0and Stemline (ended). Other authors have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The trial was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. The protocol was approved by institutional review boards or independent ethics committees at each participating trial center before the start of the trial.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent to participate in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}}],"article-number":"5"}}