[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639848":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":49,"locations":57,"responsibleParty":98,"collaborators":36,"id":100,"slug":36,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":36,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":36,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":60,"whyStopped":36,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"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",[58,79,90],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Mary Crowley Cancer Research","RECRUITING","Dallas","Texas","75251","United States",{"type":66,"coordinates":67},"Point",[68,69],-96.80667,32.78306,{"lat":69,"lon":68},[72,76],{"name":73,"role":52,"phone":74,"phoneExt":36,"email":75},"Pramitha Kondancheri","972-566-3000","Pramitha.RarothKondancheri@scri.com",{"name":77,"role":78,"phone":36,"phoneExt":36,"email":36},"Reva Schneider","PRINCIPAL_INVESTIGATOR",{"facility":80,"status":60,"city":81,"state":82,"zip":83,"country":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":36},"Novartis Investigative Site","Hirakata","Osaka","5731191","Japan",{"type":66,"coordinates":86},[87,88],135.64914,34.81352,{"lat":88,"lon":87},{"facility":80,"status":60,"city":91,"state":36,"zip":92,"country":91,"cosmosGeoPoint":93,"geoPoint":97,"contacts":36},"Singapore","119074",{"type":66,"coordinates":94},[95,96],103.85007,1.28967,{"lat":96,"lon":95},{"type":99,"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":110,"type":111},194,"ESTIMATED","INTERVENTIONAL",[114],"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.",[117],"Advanced HR+\u002FHER2- Breast Cancer",[33,119,120,121],"HR+\u002FHER2- advanced breast cancer","letrozole","fulvestrant","2026-06-29",{"date":124,"type":125},"2026-06-30","ACTUAL",{"date":127,"type":125},"2026-05-28",{"date":129,"type":111},"2032-06-08",{"name":51,"class":6},3]