[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2cep17-ratio\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2cep17-ratio":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":19,"type":20},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.",[24,25],"Breast Cancer","HER2\u002FCEP17 Ratio",[27,28],"HER2\u002FCEP17 ratio","Breast cancer","RECRUITING","2026-01-21",{"date":32,"type":33},"2026-01-29","ACTUAL",{"date":35,"type":33},"2026-01-10",{"date":37,"type":20},"2026-06-20",{"name":39,"class":40},"Shandong Cancer Hospital and Institute","OTHER"]