[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639848":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":49,"locations":57,"responsibleParty":101,"collaborators":36,"id":103,"slug":36,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":36,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":36,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":60,"whyStopped":36,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,19,24,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation: IEV407 single agent","EXPERIMENTAL","IEV407 single agent",[13],"Drug: IEV407",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose escalation: IEV407 + fulvestrant","IEV407 in combination with fulvestrant",[13,18],"Drug: Fulvestrant",{"label":20,"type":10,"description":21,"interventionNames":22},"Dose escalation: IEV407 + letrozole","IEV407 in combination with letrozole",[13,23],"Drug: Letrozole",{"label":25,"type":10,"description":16,"interventionNames":26},"Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant",[13,18],{"label":28,"type":10,"description":16,"interventionNames":29},"Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant",[13,18],[31,37,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","IEV407","Oral administration",[15,20,9,28,25],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Fulvestrant","Intramuscular injection. Approved medication.",[15,28,25],[42],"Faslodex",{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Letrozole","Oral administration. Approved medication.",[20],[48],"Femara",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":36,"email":54},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":51,"role":52,"phone":56,"phoneExt":36,"email":36},"+41613241111",[58,80,92],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Mary Crowley Cancer Research","RECRUITING","Dallas","Texas","75251","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-96.80667,32.78306,{"lat":70,"lon":69},[73,77],{"name":74,"role":52,"phone":75,"phoneExt":36,"email":76},"Pramitha Kondancheri","972-566-3000","Pramitha.RarothKondancheri@scri.com",{"name":78,"role":79,"phone":36,"phoneExt":36,"email":36},"Reva Schneider","PRINCIPAL_INVESTIGATOR",{"facility":81,"status":60,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":36},"Novartis Investigative Site","Hirakata","Osaka","5731191","Japan","JP",{"type":67,"coordinates":88},[89,90],135.64914,34.81352,{"lat":90,"lon":89},{"facility":81,"status":60,"city":93,"state":36,"zip":94,"country":93,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":36},"Singapore","119074","SG",{"type":67,"coordinates":97},[98,99],103.85007,1.28967,{"lat":99,"lon":98},{"type":102,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100639848",false,"NCT07604571","Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer","An Open-label, Multi-center, Phase I\u002FIb Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n\n  * Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):\n\nHR+\u002FHER2- aBC with disease progression on or following, or have been intolerant to, at least one line of endocrine-based therapy in combination with a CDK4\u002F6 inhibitor and at least one additional line of systemic therapy in the unresectable\u002Fmetastatic setting and not be a candidate for any available standard therapy, in the investigator's judgement.\n\n\\- Dose expansion of IEV407 in combination with fulvestrant: HR+\u002FHER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4\u002F6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable\u002Fmetastatic setting. Prior cytotoxic chemotherapy and\u002For antibody-drug conjugate therapies in the unresectable\u002Fmetastatic setting are not allowed.\n\nExclusion Criteria:\n\n* Patients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Concurrent use of hormone replacement therapy.\n* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n* For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":113,"type":114},194,"ESTIMATED","INTERVENTIONAL",[117],"PHASE1","The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.",[120],"Advanced HR+\u002FHER2- Breast Cancer",[33,122,123,124],"HR+\u002FHER2- advanced breast cancer","letrozole","fulvestrant","2026-06-29",{"date":127,"type":128},"2026-06-30","ACTUAL",{"date":130,"type":128},"2026-05-28",{"date":132,"type":114},"2032-06-08",{"name":51,"class":6},3]