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The primary analyses found no difference in 5-year overall disease-free survival (DFS) but possible benefit in subgroups. Here, we present the final landmark analysis.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>In this 4-arm, prospective, randomized, single-blinded, multi-center phase II trial, disease-free node positive and high-risk node negative breast cancer patients enrolled after standard of care therapy. Six monthly inoculations of vaccine (VG) vs. control (CG) were given as the primary vaccine series with 4 boosters at 6-month intervals. Demographic, safety, immunologic, and DFS data were evaluated.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>456 patients were enrolled; 154 patients in the VG and 147 in CG for AE37, 89 patients in the VG and 91 in CG for GP2. The AE37 arm had no difference in DFS as compared to CG, but pre-specified exploratory subgroup analyses showed a trend towards benefit in advanced stage (<jats:italic>p<\/jats:italic>\u2009=\u20090.132, HR 0.573 CI 0.275\u20131.193), HER2 under-expression (<jats:italic>p<\/jats:italic>\u2009=\u20090.181, HR 0.756 CI 0.499\u20131.145), and triple-negative breast cancer (<jats:italic>p<\/jats:italic>\u2009=\u20090.266, HR 0.443 CI 0.114\u20131.717). In patients with both HER2 under-expression and advanced stage, there was significant benefit in the VG (<jats:italic>p<\/jats:italic>\u2009=\u20090.039, HR 0.375 CI 0.142\u20130.988) as compared to CG. The GP2 arm had no significant difference in DFS as compared to CG, but on subgroup analysis, HER2 positive patients had no recurrences with a trend toward improved DFS (<jats:italic>p<\/jats:italic>\u2009=\u20090.052) in VG as compared to CG.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>This phase II trial reveals that AE37 and GP2 are safe and possibly associated with improved clinical outcomes of DFS in certain subgroups of breast cancer patients. With these findings, further evaluations are warranted of AE37 and GP2 vaccines given in combination and\/or separately for specific subsets of breast cancer patients based on their disease biology.<\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s10549-020-05638-x","type":"journal-article","created":{"date-parts":[[2020,4,22]],"date-time":"2020-04-22T11:02:42Z","timestamp":1587553362000},"page":"391-401","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":88,"title":["Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence"],"prefix":"10.1007","volume":"181","author":[{"suffix":"II","given":"Tommy A.","family":"Brown","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Mittendorf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane F.","family":"Hale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"John W.","family":"Myers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaitlin M.","family":"Peace","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doreen O.","family":"Jackson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia M.","family":"Greene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy J.","family":"Vreeland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. 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If licensed, they are entitled to financial proceeds associated with this license per Federal policy. GP also consults in the development of the vaccines. JS is an uncompensated consultant for Antigen Express. AA is the head of 1st Department of Medical Oncology at St. Savas Anticancer Hospital in Athens, Greece. JL consults for Up To Date, MedLearning, and Physician\u2019s Education. JHL also has uncompensated consulting roles for Pfizer and Astra Zeneca. JL has additional funding for other studies via Astra Zeneca, Genentech, Pfizer\/Medivation, EMD Serono, and Novartis. JS is a consultant for Lilly, Immatics, Boston Biomedical, Carsgen, and Endocyte. All remaining authors have declared no conflicts of interest. The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Army, Department of Defense or the US Government.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"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 Helsinki declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}