[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-overexpression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-overexpression":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,64],{"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":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100620741","phase-1-a-study-of-a-selective-erbb2-inhibitor-cgt4255-in-patients-with-advanced-solid-tumors-100620741",false,"NCT07361562","A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors","A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression","Inclusion Criteria:\n\n1. Have histologically confirmed diagnosis of:\n\n   1. Part A: Locally advanced, metastatic, and\u002For unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and\u002For tumor or HER2 overexpression in tumor\n   2. Part B: Locally advanced, metastatic, and\u002For unresectable NSCLC with documented ERBB2 mutation in blood and\u002For tumor\n   3. Part C: Locally advanced, metastatic and\u002For unresectable breast cancer with documented ERBB2 mutation in blood and\u002For tumor or HER overexpression in tumor\n2. Have measurable disease per RECIST v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2.\n4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.\n3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease.\n5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug.\n6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, phase 1\u002F1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.",[26,27,28,29,30,31],"Advanced Solid Tumor, Adult","ERBB2 Altered Breast Cancer","ERBB2 Gene Amplification","HER2 Overexpression","Non-Small Cell Lung Cancer","HER2",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,31],"ERBB2 genetic alterations","Investigational Drug","Advanced Solid Tumors","ERBB2 Mutated Non Small Cell Lung Cancer","Mutated Advanced Solid Tumors","ERBB2 Brain Metastases","ERRB2 Point Mutations","ERBB2 Gene Short Variants","ERBB2 Gene Rearrangements","ERBB2 activation alteration","ERBB2 gene copy number amplifications","ERBB2 gene insertions","ERRB2 gene deletions","ERBB2 gene fusions","NRG1 gene fusions","ERBB2 indel","Phase 1\u002F1b","HER2 Protein Overexpression","RECRUITING","2026-02-25",{"date":54,"type":55},"2026-02-27","ACTUAL",{"date":57,"type":55},"2025-12-30",{"date":59,"type":20},"2028-11",{"name":61,"class":62},"Cogent Biosciences, Inc.","INDUSTRY",6,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":71,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100595661","a-real-world-clinical-study-of-t-dxd-for-the-treatment-of-chinese-patients-with-her2-overexpressing-and-her2-underexpressing-advanced-breast-cancer-100595661","NCT07035353","A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer","A Clinical Study Evaluating the Efficacy and Safety of Real-world T-DXd in Treating Chinese Patients With HER2 Overexpression and HER2 Underexpression Advanced Breast Cancer","Inclusion Criteria:\n\n1. Must be competent and able to sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved ICF prior to any study-specific procedure or trial.\n2. Female patients aged ≥18 years with advanced breast cancer who are adults.\n3. Pathologically confirmed breast cancer that meets the following criteria:\n\n   1. unresectable or metastatic, with evidence of recurrent or metastatic disease.\n   2. HER2 overexpression, or HER2 hyperexpression as determined by the central laboratory in accordance with the American Society of Clinical Oncology-Society of American Pathologists guidelines.\n4. Patients must have measurable lesions according to RECIST 1.1 criteria.\n5. Unmenopausal, menopausal, and perimenopausal female patients were allowed to be enrolled.\n6. Prior antitumor therapy against recurrent metastatic disease is allowed.\n\nExclusion Criteria:\n\n1. Early stage breast cancer\n2. Patients who do not meet the criteria for HER2 overexpression and HER2 underexpression.\n3. Female patients during pregnancy or lactation.\n4. Patients deemed unsuitable for enrollment by the investigator.","FEMALE",{"count":73,"type":20},200,"OBSERVATIONAL","The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China.\n\nCohort A:\n\nHER2 overexpressing patients with advanced breast cancer\n\nCohort B:\n\nHER2 underexpressing patients with advanced breast cancer A total of 400 subjects will be enrolled in the program, with 200 enrolled in Cohort A and 200 enrolled in Cohort B. The study will be conducted by a physician in accordance with current clinical practice. The treatment plan will be recommended to the subjects by the treating physician based on the current clinical practice guidelines in conjunction with the clinical practice, and the patient's decision to be treated with T-DXd (DS8201) should precede enrollment in this study. Because of the non-interventional nature of this study, this study does not alter or interfere with clinician treatment decisions, and the actual medical practice of patients.\n\nInclusion in the study after the first treatment with the drug is based on inclusion\u002Fexclusion criteria. Subject enrollment in this study should be within 2 months of the subject's first dose of medication and prior to the first efficacy assessment. Demographic data, past medical and treatment history, ECOG score, vital signs + physical examination, laboratory tests, objective tumor evaluation, coadministration\u002Fconcomitant therapy, adverse events, time to progression\u002Fdeath, and subsequent antitumor therapy were collected at baseline, during treatment, and at subsequent follow-up. Imaging evaluation was performed according to RECIST 1.1 criteria. Adverse events evaluation criteria were based on NCI-CTCAE version 5.0.",[29,77,78],"Advanced Stage Breast Cancer","Low Expression of HER2","NOT_YET_RECRUITING","2025-06-23",{"date":82,"type":55},"2025-06-25",{"date":84,"type":20},"2025-06-30",{"date":86,"type":20},"2035-05-01",{"name":88,"class":89},"Tianjin Medical University Cancer Institute and Hospital","OTHER"]