[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SciClone Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,58],{"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":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100558269","current-status-of-treatment-for-chinese-patients-with-esr1-mutated-hrher2-advanced-breast-cancer-100558269",false,"NCT06548919","Current Status of Treatment for Chinese Patients With ESR1-mutated HR+\u002FHER2-advanced Breast Cancer","Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+\u002FHER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy: a Prospective, Non-interventional, Real-world Study","Inclusion Criteria:\n\n* 1\\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.\n* 2\\. female ≥ 18 years of age\n* 3\\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \\\u003C age ≤ 60 years old with 1 year of menopause. d) Age \\\u003C60 years and receiving ovarian suppression therapy.\n* 4\\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.\n* 5\\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.\n* 6\\. have normal organ function (as assessed by the investigator).\n\nExclusion Criteria:\n\n* 1\\. women who are pregnant or breastfeeding\n* 2\\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements\n* 3\\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator","FEMALE","18 Years",{"count":19,"type":20},450,"ESTIMATED","OBSERVATIONAL","This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+\u002FHER2-advanced breast cancer after failure of endocrine therapy.\n\nEpidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation\u002Fwithdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.",[24,25],"ESR1 Gene Mutation","Advanced Breast Cancer","RECRUITING","2024-08-07",{"date":29,"type":30},"2024-08-12","ACTUAL",{"date":32,"type":30},"2024-08-08",{"date":34,"type":20},"2027-12-31",{"name":36,"class":37},"SciClone Pharmaceuticals","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":47,"conditions":48,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":38},"100557935","safety-of-elacestrant-in-erher2--and-esr1-mutations-mbc-100557935","NCT06544577","Safety of Elacestrant in ER+\u002FHER2- and ESR1 Mutations MBC","Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+\u002FHER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study",{"count":46,"type":20},350,"This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+\u002FHER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.",[24,25,49],"Safety","2024-08-05",{"date":52,"type":30},"2024-08-09",{"date":54,"type":30},"2024-07-13",{"date":56,"type":20},"2026-08-01",{"name":36,"class":37},{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100519744","phase-4-naxitamab-and-granulocyte-macrophage-colony-stimulating-factor-gm-csf-combined-with-isotretinoin-for-maintenance-treatment-of-patients-with-high-risk-neuroblastoma-in-first-complete-response-100519744","NCT06047535","Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.","Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response. A Single-Arm, Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Documented NB at time of diagnosis defined as26:\n\n   1. histopathology of solid tumor biopsy, or\n   2. BM aspirate or biopsy indicative of NB plus high blood or urine catecholamine metabolite levels\n2. Documented high-risk disease at time of initial diagnosis defined as24, 26:\n\n   1. MYCN-amplified at stage L2, M or MS (according to International Neuroblastoma Risk Group (INRG)) of any age or\n   2. MYCN-nonamplified with stage M (according to INRG) and diagnosed at ≥ 18 months of age or\n3. Subjects must have completed frontline therapy described in 6.3.2 and have verified complete response according to INRC25 (BM MRD is allowed as assessed by RTqPCR at site28) after completion of induction and consolidation with or without ASCT\n4. Age ≥ 12 months at trial enrollment\n5. Life expectancy of greater than 6 months, as judged by the Investigator\n6. Written informed consent from legal guardian(s) and\u002For patient in accordance with local regulations. Children must provide assent as required by local regulations\n\nExclusion Criteria:\n\n1. Verified PD during induction or consolidation therapy\n2. Any systemic anti-cancer therapy, including chemotherapy, within 3 weeks prior to enrollment\n3. ASCT within 6 weeks prior to enrollment or ongoing toxicity caused by the ASCT at the discretion of the Investigator\n4. Therapeutic 131I-MIBG within 6 weeks prior to enrollment\n5. Prior anti-GD2 therapy\n6. Performance status of \\\u003C 50% as per the Lansky scale (patients less than 16 years of age) or Karnofsky scale (patients aged 16 years or older)\n7. Left ventricular ejection fraction \\\u003C 50% by echocardiography\n8. Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and\u002For chronic oxygen requirement. In addition, room air pulse oximetry \\\u003C 94% and\u002For abnormal pulmonary function tests if these assessments are necessary at the discretion of the Investigator\n9. Life threatening infection(s)\n10. Treatment with long-acting myeloid growth factor within 14 days or short-acting myeloid growth factor within 7 days prior to first dose of GM-CSF\n11. Treatment with immunosuppressive agents (local steroids excluded) within 4 weeks prior to enrollment\n12. History of allergy or known hypersensitivity to GM-CSF, E. coli-derived products, or any component of GM-CSF, naxitamab, isotretinoin or vitamin A.\n13. NB in the Central Nervous System (CNS) or leptomeningeal disease within 6 months prior to enrollment\n14. Patients with uncontrolled seizure disorders despite anticonvulsant therapy (defined as a seizure event within 3 months prior to enrollment)\n15. Unacceptable hematological status prior to first dosing, defined as one of the following:\n\n    1. Hemoglobin \\\u003C5.0 mmol\u002FL (\\\u003C8 g\u002FdL)\n    2. White blood cell (WBC) count \\\u003C1000\u002FµL\n    3. Absolute neutrophil count (ANC)\\\u003C750\u002FµL\n    4. Platelet count \\\u003C75,000\u002FµL\n16. Unacceptable liver function prior to first dosing, defined as one of the following:\n\n    1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>5 times upper normal limit (UNL)\n    2. Bilirubin \\>1.5 x UNL\n17. Unacceptable kidney function prior to first dosing, defined as:\n\n    a. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2 calculated by the 2009 revised Bedside Schwartz Equation27 (Please refer to Appendix 1)\n18. Inability to comply with protocol, as judged by the Investigator\n19. Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of trial agents or to significantly increase the severity of the toxicities experienced from trial treatment\n20. Females of childbearing potential who are pregnant, breast feeding, intend to become pregnant, or are not using adequate contraceptive methods or males who are not using adequate contraceptive methods. Contraception must be used for 1 month after last isotretinoin treatment and 42 days after last naxitamab treatment whichever comes last for both genders","ALL","12 Months",{"count":68,"type":20},62,"INTERVENTIONAL",[71],"PHASE4","This is a single-arm, multicenter clinical trial conducted in patients ≥ 12 months of age with high-risk neuroblastoma in first complete response. 62 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin.\n\nIn line with post-consolidation maintenance treatment of high-risk neuroblastoma, this trial will include patients with high-risk neuroblastoma in first complete response. Patients must have completed a multimodal frontline regimen (induction and consolidation) and have achieved complete response (positive bone marrow minimal residual disease as assessed by RTqPCR is allowed) following the multi agent induction and consolidation therapy.",[74],"Neuroblastoma",[76],"high-risk neuroblastoma with first complete response","NOT_YET_RECRUITING","2023-09-18",{"date":80,"type":30},"2023-09-21",{"date":82,"type":20},"2023-10-31",{"date":84,"type":20},"2027-08-15",{"name":36,"class":37},""]