[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635903":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":110,"collaborators":26,"id":112,"slug":26,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":26,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":26,"enrollmentInfo":120,"targetDuration":26,"studyType":123,"phases":124,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Faeth Therapeutics","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant","EXPERIMENTAL","Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and fulvestrant administered intramuscularly.",[13,14,15],"Drug: Serabelisib","Drug: Sapanisertib","Drug: Fulvestrant",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant","Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) at a higher dose than Cohort A1 administered orally and fulvestrant administered intramuscularly.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Serabelisib","Serabelisib is a selective, small molecule inhibitor of PI3Kα.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sapanisertib","Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine\u002Fthreonine kinase.",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Fulvestrant","Fulvestrant is a first-in-class SERD.",[9,17],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Medical Monitor","CONTACT","(708) 406-9282","clinicaltrials@faeththerapeutics.com",[42,55,65,75,85,95,104],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"START Los Angeles","RECRUITING","Los Angeles","California","90025","United States",{"type":50,"coordinates":51},"Point",[52,53],-118.24368,34.05223,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":58,"zip":59,"country":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":26},"Rocky Mountain Cancer Centers","Lone Tree","Colorado","80124",{"type":50,"coordinates":61},[62,63],-104.8863,39.55171,{"lat":63,"lon":62},{"facility":66,"status":44,"city":67,"state":68,"zip":69,"country":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":26},"Oncology Associates of Oregon","Springfield","Oregon","97477",{"type":50,"coordinates":71},[72,73],-123.02203,44.04624,{"lat":73,"lon":72},{"facility":76,"status":44,"city":77,"state":78,"zip":79,"country":48,"cosmosGeoPoint":80,"geoPoint":84,"contacts":26},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":50,"coordinates":81},[82,83],-86.78444,36.16589,{"lat":83,"lon":82},{"facility":86,"status":44,"city":87,"state":88,"zip":89,"country":48,"cosmosGeoPoint":90,"geoPoint":94,"contacts":26},"Texas Oncology - Central\u002FSouth","Austin","Texas","78731",{"type":50,"coordinates":91},[92,93],-97.74306,30.26715,{"lat":93,"lon":92},{"facility":96,"status":44,"city":97,"state":88,"zip":98,"country":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":26},"START San Antonio","San Antonio","78229",{"type":50,"coordinates":100},[101,102],-98.49363,29.42412,{"lat":102,"lon":101},{"facility":105,"status":44,"city":97,"state":88,"zip":106,"country":48,"cosmosGeoPoint":107,"geoPoint":109,"contacts":26},"Texas Oncology - San Aantonio","78240",{"type":50,"coordinates":108},[101,102],{"lat":102,"lon":101},{"type":111,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635903",false,"NCT07558733","Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer","Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+\u002FHER2- Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of HR+\u002FHER2- breast cancer.\n* Documented evidence of advanced or recurrent disease that is not amenable to surgery\u002Fradiation for curative intent.\n* Participant has received at least one prior systemic therapy.\n* At least 1 measurable or evaluable target lesion according to RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.\n* Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.\n\nExclusion Criteria:\n\n* Participants with triple-negative breast cancer.\n* Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.\n* Active malignancy (except for breast cancer, definitively treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.\n* Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.\n* Significant cardiovascular impairment.\n* Active, uncontrolled infection.\n* Concurrent participation in another therapeutic clinical trial.\n* Prior radiation therapy within 21 days prior to start of study treatment.\n* Participants who have received a prior PI3K, AKT, mTORC1\u002F2, or dual PI3K\u002FmTOR inhibitor.\n* Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.\n* Prolongation of QTc interval to \\>480 ms.\n* Type 1 or Type 2 diabetes mellitus on insulin.","ALL","18 Years",{"count":121,"type":122},32,"ESTIMATED","INTERVENTIONAL",[125,126],"PHASE1","PHASE2","The study is a Phase 1b\u002F2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and\u002For other anticancer therapies in participants with HR+\u002FHER2- advanced\u002Fmetastatic breast cancer.",[129],"HR+ HER2- Breast Cancer",[23,28,32,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160],"Palbociclib","PI3K","mTOR","Dual PI3K\u002FmTOR inhibition","Genetic Mutation","Faslodex","SERDs","Select Estrogen Receptor Degraders","CDK","CDK46","CDK4-6","HER2-","HER2 negative","HR+","HR positive","Hormone Receptor Positive","Advanced Breast Cancer","Metastatic Breast Cancer","Recurrent Breast Cancer","Breast Cancer","Cancer of the breast","Carcinoma of the breast","Neoplasms, Breast","Metabolism","Synthetic Lethality","Metabolism Programming","PIK3CA","Oral Medications","Antineoplastic agents","AKT","2026-06-30",{"date":163,"type":164},"2026-07-02","ACTUAL",{"date":166,"type":164},"2026-04-22",{"date":168,"type":122},"2033-05",{"name":5,"class":6},7]