{"id":29,"date":"2025-12-11T22:07:54","date_gmt":"2025-12-11T20:07:54","guid":{"rendered":"https:\/\/prelude-study.gr\/?page_id=29"},"modified":"2026-02-15T11:58:51","modified_gmt":"2026-02-15T09:58:51","slug":"en","status":"publish","type":"page","link":"https:\/\/prelude-study.gr\/?page_id=29","title":{"rendered":"EN"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">PRELUDE<\/h2>\n\n\n\n<p>A <strong><span style=\"text-decoration: underline;\">P<\/span><\/strong>rospective, Multicenter&nbsp;<strong><span style=\"text-decoration: underline;\">RE<\/span><\/strong>gistry to Observe the Treatment Patterns, Clinica<strong><span style=\"text-decoration: underline;\">L<\/span><\/strong>&nbsp;O<span style=\"text-decoration: underline;\"><strong>U<\/strong><\/span>tcomes, and&nbsp;<strong><span style=\"text-decoration: underline;\">D<\/span><\/strong>ecision-Making in Patients with Early Breast Cancer Eligible for&nbsp;<strong><span style=\"text-decoration: underline;\">E<\/span><\/strong>ndoPredict\u00ae Testing.<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Study objective<\/h2>\n\n\n\n<p>The objective of the study is to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict\u00ae testing or not. In addition, beyond the general population with luminal breast cancer, the study aims to focus on subgroups with specific characteristics and to evaluate the effectiveness of the EndoPredict\u00ae test under real-world clinical conditions.<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Inclusion criteria<\/h2>\n\n\n\n<p>Participants must meet <span style=\"text-decoration: underline;\">all<\/span> of the following criteria:<br>\u2022 Age \u2265 18 years<br>\u2022 Histological diagnosis of invasive breast cancer<br>\u2022 Tumor size pT1-T3<br>\u2022 0-3 positive axillary lymph nodes<br>\u2022 Histologically confirmed ER-positive tumors<br>\u2022 Histologically confirmed HER2-negative tumors and\/or confirmed by in situ hybridization<br>\u2022 Dated and signed informed consent form (ICF)<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Exclusion criteria<\/h2>\n\n\n\n<p>When <span style=\"text-decoration: underline;\">any<\/span> of the following is present the patient cannot participate:<br>\u2022 History of another malignant tumor within the last 5 years (except skin carcinoma, apart from melanoma).<br>\u2022 Neoadjuvant (preoperative) chemotherapy.<br>\u2022 Informed consent form (ICF) not dated \/ signed.<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Endpoints<\/h2>\n\n\n\n<p>\u2022 Primary endpoints: OS, DRFS, LRFS at 5 and 10 years, by risk group.<br>\u2022 Patient or tumor characteristics that may affect treatment decision-making (age, menopausal status, histopathological features, etc.)<br>\u2022 Performance of EndoPredict in specific population subgroups.<br>\u2022 Disease outcome (OS, DRFS, LRFS) in special categories such as multicentric\u2013multifocal disease, etc.<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Study duration and timelines<\/h2>\n\n\n\n<p>\u2022 Study start: Q1 2025<br>\u2022 Patient enrollment period: 3 years<br>\u2022 Follow-up period: 10 years<br>\u2022 Study completion: Q4 2038<\/p>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>This study has been registered with ClinicalTrials.gov under identifier: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07389408?term=NCT07389408\">NCT07389408<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PRELUDE A Prospective, Multicenter&nbsp;REgistry to Observe the Treatment Patterns, ClinicaL&nbsp;OUtcomes, and&nbsp;Decision-Making in Patients with Early Breast Cancer Eligible for&nbsp;EndoPredict\u00ae Testing. Study objective The objective of the study is to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict\u00ae testing or not. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-29","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/prelude-study.gr\/index.php?rest_route=\/wp\/v2\/pages\/29","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/prelude-study.gr\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/prelude-study.gr\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/prelude-study.gr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/prelude-study.gr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=29"}],"version-history":[{"count":8,"href":"https:\/\/prelude-study.gr\/index.php?rest_route=\/wp\/v2\/pages\/29\/revisions"}],"predecessor-version":[{"id":100,"href":"https:\/\/prelude-study.gr\/index.php?rest_route=\/wp\/v2\/pages\/29\/revisions\/100"}],"wp:attachment":[{"href":"https:\/\/prelude-study.gr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=29"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}