[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621865":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":14,"locations":20,"responsibleParty":34,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"HER2 FISH ultra",null,"HER2\u002FCEP17 FISH ratio in HER2-positive non-metastatic breast cancer",{"label":13,"type":10,"description":11,"interventionNames":10},"HER2 FISH normal",[15],{"name":16,"role":17,"phone":18,"phoneExt":10,"email":19},"Fangchao Zheng, MD","CONTACT","86-67627005","sgzhfch@yeah.net",[21],{"facility":22,"status":23,"city":24,"state":25,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":10},"Department of Medical Oncology","RECRUITING","Jinan","Shandong","China","CN",{"type":29,"coordinates":30},"Point",[31,32],116.99722,36.66833,{"lat":32,"lon":31},{"type":35,"investigatorFullName":16,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Clinical associate professor","100621865","the-prognostic-impact-of-her2-expression-in-non-metastatic-her2-positive-breast-cancer-treated-with-dual-her2-targeted-therapy-100621865",false,"NCT07376174","The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy","A Multicenter Retrospective Cohort Study Protocol on the Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition).\n3. HER2-positive status confirmed by FISH testing (per ASCO\u002FCAP guidelines) with available HER2\u002FCEP17 ratio.\n4. Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting.\n5. Underwent curative-intent surgery (mastectomy or breast-conserving surgery).\n\nExclusion Criteria:\n\n1. Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis.\n2. Previous anti-HER2 targeted therapy prior to dual-target treatment.\n3. Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date).\n4. Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies.\n5. Loss to follow-up or follow-up duration \\\u003C3 months (unless recurrence or death occurred within this period).","FEMALE","18 Years",{"count":47,"type":48},300,"ESTIMATED","OBSERVATIONAL","Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2\u002FCEP17 ratio \\>7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.",[52,53],"Breast Cancer","HER2\u002FCEP17 Ratio",[55,56],"HER2\u002FCEP17 ratio","Breast cancer","2026-01-21",{"date":59,"type":60},"2026-01-29","ACTUAL",{"date":62,"type":60},"2026-01-10",{"date":64,"type":48},"2026-06-20",{"name":5,"class":6},1]