[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621865":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":13,"overallOfficials":13,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":13,"id":47,"slug":13,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":13,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":13,"enrollmentInfo":55,"targetDuration":13,"studyType":58,"phases":13,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":13,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-free survival based on HER2\u002FCEP17 ratio","Defined as the period from the date of pathological diagnosis until the date of the first relapse, appearance of non-breast primary cancer, death with no signs or symptoms of recurrence or metast, or the last recorded follow-up ,whichever came first.","From the date of pathological diagnosis to event with follow-up duration ≥3 months (unless recurrence or death occurred within 3 month).",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","RETROSPECTIVE","HER2-positive patients with breast cancer were enrolled between January 2020 and December 2023.",[19,22],{"label":20,"type":13,"description":21,"interventionNames":13},"HER2 FISH ultra","HER2\u002FCEP17 FISH ratio in HER2-positive non-metastatic breast cancer",{"label":23,"type":13,"description":21,"interventionNames":13},"HER2 FISH normal",[25],{"name":26,"role":27,"phone":28,"phoneExt":13,"email":29},"Fangchao Zheng, MD","CONTACT","86-67627005","sgzhfch@yeah.net",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":13,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":13},"Department of Medical Oncology","RECRUITING","Jinan","Shandong","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.99722,36.66833,{"lat":42,"lon":41},{"type":45,"investigatorFullName":26,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Clinical associate professor","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":56,"type":57},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.",[61,62],"Breast Cancer","HER2\u002FCEP17 Ratio",[64,65],"HER2\u002FCEP17 ratio","Breast cancer","2026-01-21",{"date":68,"type":69},"2026-01-29","ACTUAL",{"date":71,"type":69},"2026-01-10",{"date":73,"type":57},"2026-06-20",{"name":5,"class":6},1]