{"id":39122,"date":"2025-07-29T11:17:06","date_gmt":"2025-07-29T09:17:06","guid":{"rendered":"https:\/\/www.abcsg.org\/?page_id=39122"},"modified":"2026-03-17T17:05:01","modified_gmt":"2026-03-17T16:05:01","slug":"abcsg-65-defintive-overview","status":"publish","type":"page","link":"https:\/\/www.abcsg.org\/en\/abcsg-studien\/studies-open-for-enrollment\/abcsg-65-defintive\/abcsg-65-defintive-overview\/","title":{"rendered":"ABCSG 65 \/ DEFINTIVE Study Details"},"content":{"rendered":"

D<\/strong>iagnostic HE<\/strong>R2DX-guided treatment F<\/strong>or patI<\/strong>eN<\/strong>ts wI<\/strong>th early-stage HER2-posiTIVE<\/strong> breast cancer<\/p>\n

An international, multicenter, prospective, two-arm, randomized, open-label Phase III study designed to demonstrate that personalized treatment decisions in HER2-positive early-stage breast cancer using the HER2DX\u00ae diagnostic test improve quality of life without compromising outcomes and survival rates.<\/p>\n\n\n\n\n\n\n
Study Start:<\/td>\n(global): 11\/2024, \u00a0FPI 11\/2024
\n(national): 07\/2025<\/td>\n<\/tr>\n
Coordinating Investigator AT:<\/td>\nSimon Gampenrieder, Salzburg<\/td>\n<\/tr>\n
Participants:<\/td>\n315 (global), 61 (national)<\/td>\n<\/tr>\n
Study Design:
\n(Click to enlarge)<\/em><\/td>\n		\"Study<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Treatment<\/h3>\n

Patients who meet randomization eligibility criteria will be randomized in a 1:1 ratio:<\/p>\n

    \n
  • Arm A:<\/strong> Blinded HER2DX result – Treatment according to the physician\u2019s choice and local guidelines<\/li>\n
  • Arm B:<\/strong> Available HER2DX result – HER2DX guided treatment<\/li>\n<\/ul>\n

    HER2DX test results will be shown only for patients randomized to ARM B.<\/p>\n

    Randomization will be stratified by the following factors:<\/p>\n

      \n
    • HER2DX risk group <\/strong>(high vs. low groups): Risk of recurrence following curative intent therapy.<\/li>\n
    • HER2DX pCR likelihood group <\/strong>(high vs. medium vs. low groups): The likelihood of the tumor completely disappearing after undergoing neoadjuvant trastuzumab-based CT.<\/li>\n<\/ul>\n

      Primary Objectives<\/h3>\n
        \n
      • To determine whether there is an improvement in the health-related quality of life (HRQoL) following tailored treatment by HER2DX compared with standard of care treatment.<\/li>\n
      • To evaluate whether the strategy of tailoring treatment by HER2DX presents a similar rate of responses than the standard of care treatment.<\/li>\n<\/ul>\n

        Secondary Objectives<\/h3>\n
          \n
        • To evaluate other HRQoL patient-reported outcomes (functional and symptom values) following tailored treatment by HER2DX compared with standard of care treatment.<\/li>\n
        • To evaluate whether strategy of tailoring treatment by HER2DX presents similar effectiveness outcomes than the standard of care treatment.<\/li>\n
        • To evaluate the association between HER2DX scores and efficacy outcomes<\/li>\n
        • To assess the safety and tolerability of test guided treatment and their corresponding standard treatment.<\/li>\n
        • To evaluate patient experience in control arm compared to those treated using the test and assess whether the inclusion of HER2DX test has an impact on patient experience.<\/li>\n
        • To analyze the economic impact of the HER2DX test.<\/li>\n
        • To evaluate whether the potential treatment de-escalation following tailored treatment by HER2DX could have impact in the work productivity.<\/li>\n<\/ul>\n

          Exploratory Objective<\/h3>\n
            \n
          • To explore biomarkers identified at baseline using available clinical or pathological data, or remaining RNA from tumor samples.<\/li>\n<\/ul>\n

            Patient Population<\/h3>\n
              \n
            • The target population of interest in this study consists of patients with HER2- early breast cancer stage II-IIIa.<\/li>\n
            • This trial will be conducted in men and pre\/postmenopausal women.<\/li>\n
            • Patients have not received any prior treatment for breast disease.<\/li>\n
            • Patients enrolled in this protocol are permitted to participate in additional parallel investigational drug(s) and\/or device(s) studies while on treatment as long as it does not interfere with the treatment, tests and follow-up of the DEFINITIVE protocol.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

              Diagnostic HER2DX-guided treatment For patIeNts wIth early-stage HER2-posiTIVE breast cancer An international, multicenter, prospective, two-arm, randomized, open-label Phase III study designed to demonstrate that personalized treatment decisions in HER2-positive early-stage breast cancer using the HER2DX\u00ae diagnostic test improve quality of life without compromising outcomes and survival rates. Study Start: (global): 11\/2024, \u00a0FPI 11\/2024 (national): 07\/2025 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":39064,"menu_order":33,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-39122","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-12-01 15:27:13","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\/39122","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=39122"}],"version-history":[{"count":5,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/39122\/revisions"}],"predecessor-version":[{"id":41247,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/39122\/revisions\/41247"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/39064"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=39122"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=39122"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}