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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe 2005 results of large randomized trials, including the Trastuzumab in Treating Women with Primary Breast Cancer [HERA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00045032\u0026amp;atom=%2Fspmdc%2F12%2F15%2F11.atom\u0022\u003ENCT00045032\u003C\/a\u003E] trial, demonstrated statistically significant disease-free survival benefit for 1 year of treatment with trastuzumab compared with observation in patients with human epidermal growth factor receptor 2-positive early breast cancer. After 2005, the HERA trial focused on the secondary objective of comparing 2 years of trastuzumab treatment with 1 year of treatment, and this article discusses the results of this analysis.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EAdjuvant\/Neoadjuvant Therapy\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EBreast Cancer\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe 2005 results of large randomized trials, including the Trastuzumab in Treating Women with Primary Breast Cancer [HERA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00045032\u0026amp;atom=%2Fspmdc%2F12%2F15%2F11.atom\u0022\u003ENCT00045032\u003C\/a\u003E] trial, demonstrated statistically significant disease-free survival (DFS) benefit for 1 year of treatment with trastuzumab compared with observation in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After 2005, the HERA trial focused on the secondary objective of comparing 2 years of trastuzumab treatment with 1 year of treatment. The results of this analysis were presented by Richard D. Gelber, MD, PhD, International Breast Cancer Study Group Statistical Center, Boston, Massachusetts, USA.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EA total of 5102 patients with HER2-positive invasive early breast cancer were randomized after adjuvant treatment to observation (1698), 1 year of trastuzumab (n=1703), or 2 years of trastuzumab (n=1701). Patients in the observation group had the option to switch to trastuzumab in 2005. Patients included in the 2 years (n=1553) versus 1 year (n=1552) of trastuzumab analysis were those who remained disease-free for at least 366 days from randomization. For the safety analysis, primary cardiac events were defined as NYHA Class III\/IV plus left ventricular ejection fraction (LVEF) \u0026lt;50% and \u226510% below baseline, or cardiac death. Secondary cardiac events were defined as LVEF \u0026lt;50% and \u226510% below baseline, excluding patients with a primary cardiac event.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAt 8 years of median follow-up, DFS rates were 75.8% in the 2-year group versus 76.0% in the 1-year group (HR, 0.99; 95% CI, 0.85 to 1.14; p=0.86). DFS was not significantly different with 2 years versus 1 year of trastuzumab in either hormone receptor-positive (76.1% vs 77.2%; HR, 1.05; 95% CI, 0.85 to 1.29; p=0.67) or -negative (75.4% vs 74.7%; HR, 0.93; 95% CI, 0.76 to 1.14; p=0.51) patients. OS rates at 8 years of median follow-up were 86.4% with 2 years of treatment versus 87.6% with 1 year of treatment (HR, 1.05; 95% CI, 0.86 to 1.28; p=0.63).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn the safety analysis population, grade 3\/4 adverse events (AEs) were reported in 20.4% of the 2-year group (n=1673), 16.3% of the 1-year group (n=1682), and 8.2% of the observation group (n=1744). Fatal AEs occurred in 1.2% of the 2-year group, 1.1% of the 1-year group, and 0.4% of the observation group. Primary cardiac events occurred in 1.0% of the 2-year group, 0.8% of the 1-year group, and 0.1% of the observation group. Secondary cardiac events occurred in 7.2% of the 2-year group, 4.1% of the 1-year group, and 0.9% of the observation group.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EResults at median follow-up of 8 years also demonstrated sustained and statistically significant DFS and OS benefits with 1 year of trastuzumab treatment versus observation in the intention-to-treat analysis despite selective crossover.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe authors concluded that 2 years of treatment with trastuzumab did not provide long-term benefit compared with 1 year of treatment when administered as sequential treatment following chemotherapy. Cardiac toxicity and other AEs were increased in the 2-year treatment arm. The HERA results confirm that 1 year of trastuzumab treatment is the standard of care as part of adjuvant therapy for patients with HER2-positive early breast cancer.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/15\/11.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn7sq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}