{"id":39599,"date":"2025-08-27T06:07:05","date_gmt":"2025-08-27T04:07:05","guid":{"rendered":"https:\/\/www.abcsg.org\/?page_id=39599"},"modified":"2026-02-05T10:32:22","modified_gmt":"2026-02-05T09:32:22","slug":"abcsg-63-erika-study-details","status":"publish","type":"page","link":"https:\/\/www.abcsg.org\/en\/abcsg-studien\/studies-open-for-enrollment\/abcsg-63-erika\/abcsg-63-erika-study-details\/","title":{"rendered":"ABCSG 63 \/ ERIKA Study Details"},"content":{"rendered":"

E<\/strong>lacestrant and RI<\/strong>bociclib in K<\/strong>i67-tested endocrine responsive breA<\/strong>st cancer<\/p>\n

An open-label, two-arm, randomized, phase II study of elacestrant plus ribociclib vs. AI (plus GnRH agonist in pre-\/perimenopausal women and men) plus ribociclib as\u00a0neoadjuvant therapy for endocrine-responsive HER2-negative early breast cancer<\/p>\n\n\n\n\n\n\n
Studienstart:<\/td>\nQ3\/2025<\/td>\n<\/tr>\n
Coordinating Investigators:<\/td>\nChristian Singer, Vienna
\nMichael Gnant, Vienna<\/td>\n<\/tr>\n
Participants:<\/td>\n120 (Austria, Germany)<\/td>\n<\/tr>\n
Study Design
\n(Click to enlarge)<\/em><\/td>\n		\"ABCSG<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Treatment:<\/h3>\n

Patients will be randomized in a 1:1 ratio to receive in step 1 either<\/p>\n

    \n
  • 1 cycle (= 28 days) of 400 mg elacestrant dihydrochloride qd plus 400 mg ribociclib qd in arm A<\/strong><\/li>\n<\/ul>\n

    OR<\/p>\n

      \n
    • 1 cycle (= 28 days) of AI (and GnRH agonist in pre-\/perimenopausal women and men) plus 400 mg ribociclib qd in arm B<\/strong><\/li>\n<\/ul>\n

      to identify endocrine-responsive tumors.<\/p>\n

      Tumors which exhibit a Ki-67 of \u226410 % at C1D22 visit as determined by local pathologist will be considered \u201cendocrine responsive\u201d and these patients will continue to receive treatment in step 2 \u2013 dependent on the initial randomization \u2013 either<\/p>\n

        \n
      • 5 cycles (= 5 x 28-day cycles) of 400 mg elacestrant dihydrochloride qd plus 400 mg ribociclib qd in arm A<\/strong><\/li>\n<\/ul>\n

        OR<\/p>\n

          \n
        • 5 cycles (= 5 x 28-day cycles) of AI (and GnRH agonist in pre-\/perimenopausal women and men) plus 400 mg ribociclib qd in arm B<\/strong><\/li>\n<\/ul>\n

          Tumors which exhibit a Ki-67 of >10 % at C1D22 visit as determined by local pathologist will be considered \u201cnon-endocrine responsive\u201d and these patients will have an EOSV scheduled and will receive further treatment at the discretion of the investigator.<\/p>\n

          Primary Objective:<\/h3>\n
            \n
          • To evaluate the superiority of the study treatment when measured by modified PEPI score at the time of surgery<\/li>\n<\/ul>\n

            Secondary Objectives:<\/h3>\n
              \n
            • To evaluate Ki-67 (at C1D22), RCB (at surgery) and pCR (at surgery)<\/li>\n
            • To evaluate changes in the radiological tumor size from screening to 3 months of treatment and to pre-surgery<\/li>\n<\/ul>\n

              Safety Objective:<\/h3>\n
                \n
              • To evaluate the safety and tolerability<\/li>\n<\/ul>\n

                Patient Reported Outcome Objectives:<\/h3>\n
                  \n
                • To evaluate quality of life at screening, at C1D22 visit, at surgery visit as well as at EOSV<\/li>\n<\/ul>\n

                  Translational Objective:<\/h3>\n
                    \n
                  • To study additional research questions \/ to perform additional analyses from biological material and \/ or clinical data that have been collected within this trial<\/li>\n<\/ul>\n

                    Patient Population<\/h3>\n
                      \n
                    • The target population of this study consists of patients (women or men) with ER+\/HER2- early breast cancer (stage cT1c-4a-c, cN0-3, M0 per AJCC v8)<\/li>\n<\/ul>\n

                      *Study information is displayed as described in study protocol V2.0. Sites must adhere to the currently approved version of the protocol.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

                      Elacestrant and RIbociclib in Ki67-tested endocrine responsive breAst cancer An open-label, two-arm, randomized, phase II study of elacestrant plus ribociclib vs. AI (plus GnRH agonist in pre-\/perimenopausal women and men) plus ribociclib as\u00a0neoadjuvant therapy for endocrine-responsive HER2-negative early breast cancer Studienstart: Q3\/2025 Coordinating Investigators: Christian Singer, Vienna Michael Gnant, Vienna Participants: 120 (Austria, Germany) Study […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":39592,"menu_order":30,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-39599","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-11-13 22:38:56","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\/39599","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=39599"}],"version-history":[{"count":3,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/39599\/revisions"}],"predecessor-version":[{"id":40961,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/39599\/revisions\/40961"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/39592"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=39599"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=39599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}