{"id":42103,"date":"2026-08-25T04:54:17","date_gmt":"2026-08-25T02:54:17","guid":{"rendered":"https:\/\/www.abcsg.org\/?page_id=42103"},"modified":"2026-08-25T05:14:12","modified_gmt":"2026-08-25T03:14:12","slug":"abcsg-66-adaptela-study-details","status":"publish","type":"page","link":"https:\/\/www.abcsg.org\/en\/abcsg-studien\/studies-open-for-enrollment\/abcsg-66-adaptela\/abcsg-66-adaptela-study-details\/","title":{"rendered":"ABCSG 66 \/ ADAPTela Study Details"},"content":{"rendered":"<p>ABCSG 66 \/ ADAPTela is a WSG-sponsored, adjuvant, open-label, interventional Phase III clinical trial for a high-risk HR-positive\/HER2-negative early breast cancer patient population, comparing elacestrant with standard of care endocrine treatment (both arms with or without ribociclib). The genomic Oncotype DX\u00ae test is used to determine a specific genomic profile of patients, making it a personalized therapeutic approach to predict treatment benefits in HR-positive\/HER2-negative early breast cancer.<\/p>\n<table class=\"studienmeta-public\">\n<tbody>\n<tr>\n<td>Study Start:<\/td>\n<td>Q2\/2026<\/td>\n<\/tr>\n<tr>\n<td>Coordinating Investigator:<\/td>\n<td>Dr. Christoph Suppan (f\u00fcr AT)<\/td>\n<\/tr>\n<tr>\n<td>Sample size:<\/td>\n<td>1520 (Germany, Spain and Austria)<\/td>\n<\/tr>\n<tr>\n<td>Studien design:<br \/>\n<em>(Click to enlarge)<\/em><\/td>\n<td><a  href=\"https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2026\/08\/image001-1.png\" data-rel=\"lightbox-gallery-0\" data-rl_title=\"\" data-rl_caption=\"\" title=\"\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-42099\" src=\"https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2026\/08\/image001-1-280x94.png\" alt=\"ABCSG 66 \/ ADAPTela Study design\" width=\"280\" height=\"94\" srcset=\"https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2026\/08\/image001-1-280x94.png 280w, https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2026\/08\/image001-1-768x258.png 768w, https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2026\/08\/image001-1.png 966w\" sizes=\"auto, (max-width: 280px) 100vw, 280px\" \/><\/a><\/td>\n<\/tr>\n<tr>\n<td>Sponsor<\/td>\n<td><a href=\"https:\/\/wsg-online.com\/\">WSG<\/a>\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>Treatment:<\/h3>\n<p><strong>1. Arm A:<\/strong> Elacestrant (+\/- CDK4\/6-Inhibitor Ribociclib) <br \/>\n<strong>2. Arm B<\/strong>: SOC ET (+\/- CDK4\/6-Inhibitor)<\/p>\n<h3>Primary Objective(s)<\/h3>\n<p>To show efficacy in terms of improved survival (iDFS) in patients receiving adjuvant elacestrant-containing therapy (+\/- CDK4\/6i) compared to SoC ET (+\/- CDK4\/6i) only<\/p>\n<h3>Secondary Objectives<\/h3>\n<ul>\n<li>Survival Objectives: <br \/>\nTo assess distant disease-free survival (dDFS), relapse-free survival<br \/>\n(RFS), DCIS disease-free survival (DFS-DCIS), invasive breast cancer-free survival (IBCFS), locoregional relapse-free survival (LRFS), and OS\u00a0<\/li>\n<li>Safety Objectives:<br \/>\nTo assess toxicity in both arms<\/li>\n<li>Translational Objectives: <br \/>\nTo assess predictive markers (translational research) at baseline and in on treatment blood samples and\/or core biopsies at different timepoints.<\/li>\n<\/ul>\n<h3>Patient Population:<\/h3>\n<p>HR-positive\/HER2-negative early-stage breast cancer patients with an intermediate to high risk of recurrence.<\/p>\n<p>At the time of study enrollment, patients must have completed standard-of-care (SoC) primary treatment (including, for example, endocrine induction therapy, (neo)adjuvant chemotherapy, surgery, and radiotherapy) and are now expected to start endocrine therapy with or without a CDK4\/6 inhibitor. If endocrine therapy (with or without a CDK4\/6 inhibitor) has already been initiated, enrollment is also permitted within 12 months of starting treatment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ABCSG 66 \/ ADAPTela is a WSG-sponsored, adjuvant, open-label, interventional Phase III clinical trial for a high-risk HR-positive\/HER2-negative early breast cancer patient population, comparing elacestrant with standard of care endocrine treatment (both arms with or without ribociclib). The genomic Oncotype DX\u00ae test is used to determine a specific genomic profile of patients, making it a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":42093,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"tags":[],"class_list":["post-42103","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2027-02-27 10:07:23","action":"delete","newStatus":"draft","terms":[],"taxonomy":"translation_priority","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42103","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/comments?post=42103"}],"version-history":[{"count":2,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42103\/revisions"}],"predecessor-version":[{"id":42107,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42103\/revisions\/42107"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42093"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=42103"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=42103"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}