{"id":40153,"date":"2025-10-23T16:38:44","date_gmt":"2025-10-23T14:38:44","guid":{"rendered":"https:\/\/www.abcsg.org\/?page_id=40153"},"modified":"2026-02-05T10:02:29","modified_gmt":"2026-02-05T09:02:29","slug":"abcsg-67n-caroleen-study-details","status":"publish","type":"page","link":"https:\/\/www.abcsg.org\/en\/abcsg-studien\/studies-open-for-enrollment\/abcsg-67n-caroleen\/abcsg-67n-caroleen-study-details\/","title":{"rendered":"ABCSG 67N \/ CAROLEEN Study Details"},"content":{"rendered":"

\u00a0A non-interventional study for riboc<\/b>iclib in combination with an a<\/b>romatase inhibitor for adjuvant treatment in patients with HR+\/HER2- ear<\/b>ly breast cancer at high risk of recurrence to<\/b> eval<\/b>uate re<\/b>al-world e<\/b>ffectiven<\/b>ess, safety profile, patient compliance and quality of life<\/p>\n\n\n\n\n\n\n
Study start:<\/td>\nglobal Q1\/2025
\nnational Q4\/2025<\/td>\n<\/tr>\n
Coordinating Investigator:<\/td>\nChristian Singer, Austria<\/td>\n<\/tr>\n
Planned Participants:<\/td>\n3250 (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

Section 1 (\u201eCross-sectional\u201c)<\/p>\n

    \n
  • Parameters leading to the treatment decision between<\/li>\n
  • ET Mono\u00b1 LHRH, Ribociclib + AI\u00b1 LHRH and Abemaciclib + ET \u00b1 LHRH<\/b>and possible changes between the first and second year of enrollment of a total enrollment period of 2 years<\/li>\n<\/ul>\n

    Section 2 (\u201eLongitudinal\u201c)<\/p>\n

      \n
    • iDFS (invasive disease-free survival<\/i>) in adjuvant treatment with Ribociclib + AI<\/b> \u00b1 LHRH after 36 months (in the total population and in subgroups of special interest, e.g. N0)<\/li>\n
    • Description of adherence and quality of life using questionnaires during adjuvant treatment with Ribociclib + AI \u00b1 LHRH<\/b> and abemaciclib + ET\u00b1 LHRH<\/b><\/li>\n<\/ul>\n

      Therefore, this study comprises a cross-sectional observation (section 1) at baseline and a longitudinal follow-up for a subset of the patients (section 2).<\/p>\n

      Primary objective:<\/h3>\n
        \n
      • \n

        Primary objective is to evaluate iDFS for adjuvant therapy with ribociclib + AI \u00b1 LHRH in patients with HR+\/HER2- eBC at 36 months (section 2).<\/p>\n<\/li>\n<\/ul>\n

        Patient Population:<\/h3>\n
          \n
        • \n

          Adult female and male patients with an indication for adjuvant treatment with ribociclib + AI \u00b1 LHRH in HR+\/HER2- eBC at high risk of recurrence as described in the Summary of Product Characteristics (SmPC)<\/p>\n<\/li>\n<\/ul>\n

          * Study information is displayed as described in study protocol V01. Sites must adhere to the currently approved version of the protocol.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"

          \u00a0A non-interventional study for ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+\/HER2- early breast cancer at high risk of recurrence to evaluate real-world effectiveness, safety profile, patient compliance and quality of life Study start: global Q1\/2025 national Q4\/2025 Coordinating Investigator: Christian Singer, Austria Planned Participants: 3250 (Austria, Germany) Study […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":40143,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-40153","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-17 07:23:23","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\/40153","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=40153"}],"version-history":[{"count":2,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/40153\/revisions"}],"predecessor-version":[{"id":40956,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/40153\/revisions\/40956"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/40143"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=40153"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=40153"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}