\n(Click to enlarge)<\/em><\/td>\n
![\"ABCSG](\"https:\/\/www.abcsg.org\/wp\/wp-content\/uploads\/2023\/03\/ABCSG57_AMBHER-280x187.jpg\")
<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nPrimary Objective<\/span><\/h3>\nTo develop a distant recurrence (DR) risk assessment model in patients with primary HER2+ BC receiving neoadjuvant systemic treatment with dual HER2-blockade (pertuzumab and trastuzumab).<\/span><\/p>\nSecondary Objective(s)<\/span><\/h3>\nTo evaluate the cardiac safety of pertuzumab and trastuzumab in combination with the standard chemotherapy in neoadjuvant setting in patients with primary HER2+ BC.<\/span><\/p>\nExploratory Objective(s)<\/span><\/h3>\nReal-world (neo-)adjuvant treatment patterns<\/span><\/p>\nThe composite risk model should help to identify the patients who can gain the greatest clinical advantage from the adjuvant administration of pertuzumab as a move towards precision medicine. It is therefore necessary to gain an understanding of the relative proportion of neoadjuvant and adjuvant treatment regimens including prescription of trastuzumab, trastuzumab biosimilars, pertuzumab, and T-DM1. Adjusted comparison should then help in gauging the potential impact of reducing subsequent cost in the metastatic setting by preventing more DRs with intensified adjuvant therapy.<\/span><\/p>\nTranslational Objective(s)<\/span><\/h3>\nEstablishment of a biobank of HER2+ tumor tissues and respective biomarker (response) assessments.<\/span><\/p>\nInclusion Criteria<\/span><\/h3>\n\n- \n
Female and male patients \u2265 18 years.<\/span><\/p>\n<\/li>\n- \n
Signed informed consent.<\/span><\/p>\n<\/li>\n- \n
Histologically confirmed adenocarcinoma of the breast.<\/span><\/p>\n<\/li>\n- \n
HER2+ disease defined as 3+ by immunohistochemistry, or 2+ by immunohistochemistry and with HER2 amplification by In Situ Hybridization (ISH).<\/span><\/p>\n<\/li>\n- \n
Patients with confirmed uni- \/ bilateral breast cancer may be included if at least one lesion is HER2+.<\/span><\/p>\n<\/li>\n- \n
Prospective patients: having received at least one dose of a neoadjuvant treatment regimen with dual HER2 blockade or scheduled to receive at least one dose of neoadjuvant treatment with dual HER2 blockade in case of patients who consented before the start of neoadjuvant therapy.<\/span><\/p>\n<\/li>\n- \n
Retrospective patients: having received at least one dose of neoadjuvant treatment regimen with dual HER2 blockade followed by definitive surgery.<\/span><\/p>\n<\/li>\n- \n
Anti-HER2 therapy started max. 5 years before registration.<\/span><\/p>\n<\/li>\n<\/ul>\nExclusion Criteria<\/span><\/h3>\n\n- \n
Metastatic or locally advanced disease (without loco-regional treatment options with curative intention) at the time of diagnosis.<\/span><\/p>\n<\/li>\n- \n
Previous cancer therapy for the same disease, other than the therapy evaluated in this NIS.<\/span><\/p>\n<\/li>\n- \n
History of other malignancy; exception: patients who have been disease-free for 5 years or patients with a history of completely resected, non-metastatic, non-melanomatous skin cancer or successfully treated in situ carcinoma are eligible.<\/span><\/p>\n<\/li>\n<\/ul>\n <\/p>\n","protected":false},"excerpt":{"rendered":"
Description of patients with HER2 positive breast cancer undergoing neoadjuvant treatment and development of a dynamic composite risk score to predict the risk of distant recurrence Study Start: FPI 03\/2023 Coordinating Investigator: Marija Balic, Graz Sample Size:: AT: 500 Study Design: (Click to enlarge) Primary Objective To develop a distant recurrence (DR) risk assessment model […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":33270,"menu_order":196,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-33282","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-09 10:31:44","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\/33282","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=33282"}],"version-history":[{"count":1,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions"}],"predecessor-version":[{"id":33283,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions\/33283"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33270"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=33282"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=33282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Secondary Objective(s)<\/span><\/h3>\nTo evaluate the cardiac safety of pertuzumab and trastuzumab in combination with the standard chemotherapy in neoadjuvant setting in patients with primary HER2+ BC.<\/span><\/p>\nExploratory Objective(s)<\/span><\/h3>\nReal-world (neo-)adjuvant treatment patterns<\/span><\/p>\nThe composite risk model should help to identify the patients who can gain the greatest clinical advantage from the adjuvant administration of pertuzumab as a move towards precision medicine. It is therefore necessary to gain an understanding of the relative proportion of neoadjuvant and adjuvant treatment regimens including prescription of trastuzumab, trastuzumab biosimilars, pertuzumab, and T-DM1. Adjusted comparison should then help in gauging the potential impact of reducing subsequent cost in the metastatic setting by preventing more DRs with intensified adjuvant therapy.<\/span><\/p>\nTranslational Objective(s)<\/span><\/h3>\nEstablishment of a biobank of HER2+ tumor tissues and respective biomarker (response) assessments.<\/span><\/p>\nInclusion Criteria<\/span><\/h3>\n\n- \n
Female and male patients \u2265 18 years.<\/span><\/p>\n<\/li>\n- \n
Signed informed consent.<\/span><\/p>\n<\/li>\n- \n
Histologically confirmed adenocarcinoma of the breast.<\/span><\/p>\n<\/li>\n- \n
HER2+ disease defined as 3+ by immunohistochemistry, or 2+ by immunohistochemistry and with HER2 amplification by In Situ Hybridization (ISH).<\/span><\/p>\n<\/li>\n- \n
Patients with confirmed uni- \/ bilateral breast cancer may be included if at least one lesion is HER2+.<\/span><\/p>\n<\/li>\n- \n
Prospective patients: having received at least one dose of a neoadjuvant treatment regimen with dual HER2 blockade or scheduled to receive at least one dose of neoadjuvant treatment with dual HER2 blockade in case of patients who consented before the start of neoadjuvant therapy.<\/span><\/p>\n<\/li>\n- \n
Retrospective patients: having received at least one dose of neoadjuvant treatment regimen with dual HER2 blockade followed by definitive surgery.<\/span><\/p>\n<\/li>\n- \n
Anti-HER2 therapy started max. 5 years before registration.<\/span><\/p>\n<\/li>\n<\/ul>\nExclusion Criteria<\/span><\/h3>\n\n- \n
Metastatic or locally advanced disease (without loco-regional treatment options with curative intention) at the time of diagnosis.<\/span><\/p>\n<\/li>\n- \n
Previous cancer therapy for the same disease, other than the therapy evaluated in this NIS.<\/span><\/p>\n<\/li>\n- \n
History of other malignancy; exception: patients who have been disease-free for 5 years or patients with a history of completely resected, non-metastatic, non-melanomatous skin cancer or successfully treated in situ carcinoma are eligible.<\/span><\/p>\n<\/li>\n<\/ul>\n <\/p>\n","protected":false},"excerpt":{"rendered":"
Description of patients with HER2 positive breast cancer undergoing neoadjuvant treatment and development of a dynamic composite risk score to predict the risk of distant recurrence Study Start: FPI 03\/2023 Coordinating Investigator: Marija Balic, Graz Sample Size:: AT: 500 Study Design: (Click to enlarge) Primary Objective To develop a distant recurrence (DR) risk assessment model […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":33270,"menu_order":196,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-33282","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-09 10:31:44","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\/33282","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=33282"}],"version-history":[{"count":1,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions"}],"predecessor-version":[{"id":33283,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions\/33283"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33270"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=33282"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=33282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Exploratory Objective(s)<\/span><\/h3>\nReal-world (neo-)adjuvant treatment patterns<\/span><\/p>\nThe composite risk model should help to identify the patients who can gain the greatest clinical advantage from the adjuvant administration of pertuzumab as a move towards precision medicine. It is therefore necessary to gain an understanding of the relative proportion of neoadjuvant and adjuvant treatment regimens including prescription of trastuzumab, trastuzumab biosimilars, pertuzumab, and T-DM1. Adjusted comparison should then help in gauging the potential impact of reducing subsequent cost in the metastatic setting by preventing more DRs with intensified adjuvant therapy.<\/span><\/p>\nTranslational Objective(s)<\/span><\/h3>\nEstablishment of a biobank of HER2+ tumor tissues and respective biomarker (response) assessments.<\/span><\/p>\nInclusion Criteria<\/span><\/h3>\n\n- \n
Female and male patients \u2265 18 years.<\/span><\/p>\n<\/li>\n- \n
Signed informed consent.<\/span><\/p>\n<\/li>\n- \n
Histologically confirmed adenocarcinoma of the breast.<\/span><\/p>\n<\/li>\n- \n
HER2+ disease defined as 3+ by immunohistochemistry, or 2+ by immunohistochemistry and with HER2 amplification by In Situ Hybridization (ISH).<\/span><\/p>\n<\/li>\n- \n
Patients with confirmed uni- \/ bilateral breast cancer may be included if at least one lesion is HER2+.<\/span><\/p>\n<\/li>\n- \n
Prospective patients: having received at least one dose of a neoadjuvant treatment regimen with dual HER2 blockade or scheduled to receive at least one dose of neoadjuvant treatment with dual HER2 blockade in case of patients who consented before the start of neoadjuvant therapy.<\/span><\/p>\n<\/li>\n- \n
Retrospective patients: having received at least one dose of neoadjuvant treatment regimen with dual HER2 blockade followed by definitive surgery.<\/span><\/p>\n<\/li>\n- \n
Anti-HER2 therapy started max. 5 years before registration.<\/span><\/p>\n<\/li>\n<\/ul>\nExclusion Criteria<\/span><\/h3>\n\n- \n
Metastatic or locally advanced disease (without loco-regional treatment options with curative intention) at the time of diagnosis.<\/span><\/p>\n<\/li>\n- \n
Previous cancer therapy for the same disease, other than the therapy evaluated in this NIS.<\/span><\/p>\n<\/li>\n- \n
History of other malignancy; exception: patients who have been disease-free for 5 years or patients with a history of completely resected, non-metastatic, non-melanomatous skin cancer or successfully treated in situ carcinoma are eligible.<\/span><\/p>\n<\/li>\n<\/ul>\n <\/p>\n","protected":false},"excerpt":{"rendered":"
Description of patients with HER2 positive breast cancer undergoing neoadjuvant treatment and development of a dynamic composite risk score to predict the risk of distant recurrence Study Start: FPI 03\/2023 Coordinating Investigator: Marija Balic, Graz Sample Size:: AT: 500 Study Design: (Click to enlarge) Primary Objective To develop a distant recurrence (DR) risk assessment model […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":33270,"menu_order":196,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-33282","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-09 10:31:44","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\/33282","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=33282"}],"version-history":[{"count":1,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions"}],"predecessor-version":[{"id":33283,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions\/33283"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33270"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=33282"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=33282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
The composite risk model should help to identify the patients who can gain the greatest clinical advantage from the adjuvant administration of pertuzumab as a move towards precision medicine. It is therefore necessary to gain an understanding of the relative proportion of neoadjuvant and adjuvant treatment regimens including prescription of trastuzumab, trastuzumab biosimilars, pertuzumab, and T-DM1. Adjusted comparison should then help in gauging the potential impact of reducing subsequent cost in the metastatic setting by preventing more DRs with intensified adjuvant therapy.<\/span><\/p>\n Establishment of a biobank of HER2+ tumor tissues and respective biomarker (response) assessments.<\/span><\/p>\n Female and male patients \u2265 18 years.<\/span><\/p>\n<\/li>\n Signed informed consent.<\/span><\/p>\n<\/li>\n Histologically confirmed adenocarcinoma of the breast.<\/span><\/p>\n<\/li>\n HER2+ disease defined as 3+ by immunohistochemistry, or 2+ by immunohistochemistry and with HER2 amplification by In Situ Hybridization (ISH).<\/span><\/p>\n<\/li>\n Patients with confirmed uni- \/ bilateral breast cancer may be included if at least one lesion is HER2+.<\/span><\/p>\n<\/li>\n Prospective patients: having received at least one dose of a neoadjuvant treatment regimen with dual HER2 blockade or scheduled to receive at least one dose of neoadjuvant treatment with dual HER2 blockade in case of patients who consented before the start of neoadjuvant therapy.<\/span><\/p>\n<\/li>\n Retrospective patients: having received at least one dose of neoadjuvant treatment regimen with dual HER2 blockade followed by definitive surgery.<\/span><\/p>\n<\/li>\n Anti-HER2 therapy started max. 5 years before registration.<\/span><\/p>\n<\/li>\n<\/ul>\n Metastatic or locally advanced disease (without loco-regional treatment options with curative intention) at the time of diagnosis.<\/span><\/p>\n<\/li>\n Previous cancer therapy for the same disease, other than the therapy evaluated in this NIS.<\/span><\/p>\n<\/li>\n History of other malignancy; exception: patients who have been disease-free for 5 years or patients with a history of completely resected, non-metastatic, non-melanomatous skin cancer or successfully treated in situ carcinoma are eligible.<\/span><\/p>\n<\/li>\n<\/ul>\n <\/p>\n","protected":false},"excerpt":{"rendered":" Description of patients with HER2 positive breast cancer undergoing neoadjuvant treatment and development of a dynamic composite risk score to predict the risk of distant recurrence Study Start: FPI 03\/2023 Coordinating Investigator: Marija Balic, Graz Sample Size:: AT: 500 Study Design: (Click to enlarge) Primary Objective To develop a distant recurrence (DR) risk assessment model […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":33270,"menu_order":196,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-33282","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-09 10:31:44","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\/33282","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=33282"}],"version-history":[{"count":1,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions"}],"predecessor-version":[{"id":33283,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33282\/revisions\/33283"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/33270"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=33282"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=33282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Translational Objective(s)<\/span><\/h3>\n
Inclusion Criteria<\/span><\/h3>\n
\n
Exclusion Criteria<\/span><\/h3>\n
\n