\nMichael Gnant, Vienna<\/td>\n<\/tr>\n
\n(Click to enlarge)<\/em><\/td>\n
![\"ABCSG](\"https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2026\/10\/ABCSG-64_Study-design.jpg\")
<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nTreatment:<\/h3>\n
Participants will first receive an aromatase inhibitor (AI) during a 4 -week run-in phase. Following assessment of the Ki-67 value after approximately three weeks, participants with evidence of endocrine non-responsiveness will be randomized in a 1:1 ratio to one of the treatment arms: \u00a0<\/p>\n
- \n
- Arm A:<\/strong> Sacituzumab govitecan (SG)<\/li>\n
- Arm B:<\/strong> Chemotherapy (SoC)<\/li>\n<\/ul>\n
Primary Objective:<\/h3>\n
To evaluate the efficacy of neoadjuvant sacituzumab govitecan (SG) vs. SoC in endocrine non-responsive early breast cancer patients, when measured by pCR at the time of surgery<\/p>\n
\u00a0<\/strong>Secondary Objectives<\/h3>\n
- \n
- To evaluate the efficacy of neoadjuvant SG vs. SoC in endocrine non-responsive early breast cancer, when measured by RCB at the time of surgery (descriptive)<\/li>\n
- To determine the efficacy of neoadjuvant SC vs. SoC in endocrine non-responsive early breast cancer measured by long-term outcome<\/li>\n<\/ul>\n
Safety Objective<\/h3>\n
- \n
- To evaluate the safety and tolerability of neoadjuvant SC vs. SoC in endocrine non-responsive early breast cancer<\/li>\n<\/ul>\n
Patient Reported Outcome (PRO) Objective<\/h3>\n
- \n
- To evaluate PRO of neoadjuvant SG vs. SoC in endocrine non-responsive early breast cancer<\/li>\n<\/ul>\n
Translational Objectives<\/h3>\n
- \n
- To identify prognostic and predictive markers in endocrine non-responsive early breast cancer<\/li>\n
- To study additional research questions \/ to perform additional analyses from biological material and \/ or clinical as well as imaging data<\/li>\n<\/ul>\n
Patient population<\/h3>\n
- \n
- The target population for this clinical trial comprises participants with ER-positive\/HER2-negative early or locally advanced breast cancer (AJCC v8.0 Stage IIA\u2013III) who have an indication for chemotherapy and have not received prior systemic therapy for breast cancer.<\/li>\n
- In addition, participants who discontinue study ABCSG 61 due to their endocrine response profile may be enrolled in ABCSG 64, provided that all applicable eligibility criteria are met.<\/li>\n<\/ul>\n
\u00a0* <\/em>The information provided is based on Study Protocol Version 1.0. Study sites must refer to the currently approved protocol version.<\/em><\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
An open-label, two-arm, randomized phase II study of Sacituzumab Govitecan vs Standard of Care as neoadjuvant therapy for endocrine non-responsive ER+\/HER2-negative early breast cancer Study start: Q4\/2026 Coordinating Investigators: Christian Singer, Vienna Michael Gnant, Vienna Sample size: 80 (national) Study design: (Click to enlarge) Treatment: Participants will first receive an aromatase inhibitor (AI) during a […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":42617,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-42623","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42623","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=42623"}],"version-history":[{"count":2,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42623\/revisions"}],"predecessor-version":[{"id":42628,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42623\/revisions\/42628"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/42617"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=42623"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=42623"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
- To evaluate PRO of neoadjuvant SG vs. SoC in endocrine non-responsive early breast cancer<\/li>\n<\/ul>\n
- To evaluate the safety and tolerability of neoadjuvant SC vs. SoC in endocrine non-responsive early breast cancer<\/li>\n<\/ul>\n
- Arm B:<\/strong> Chemotherapy (SoC)<\/li>\n<\/ul>\n