[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431535":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":46,"centralContacts":29,"locations":50,"responsibleParty":75,"collaborators":29,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":29,"enrollmentInfo":88,"targetDuration":29,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":104,"whyStopped":105,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":89},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR","EXPERIMENTAL","Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.",[13,14,15,16,17],"Drug: Alpelisib","Drug: Fulvestrant","Drug: Metformin XR","Drug: Dapagliflozin + metformin XR","Drug: Dapagliflozin",{"label":19,"type":20,"description":21,"interventionNames":22},"Alpelisib + Fulvestrant + Metformin XR","ACTIVE_COMPARATOR","Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.",[13,14,15],[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Alpelisib","Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 8 in a 28 days cycle.",[9,19],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Fulvestrant","Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 after randomization and then at Day 1 of each subsequent cycle during the randomized treatment phase.",[9,19],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Metformin XR","Metformin XR (tablets) administered at a starting dose of 500mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 days cycle. Dose titration from 500 mg once a day to 2000 mg once a day.",[9,19],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Dapagliflozin + metformin XR","Dapagliflozin + metformin XR administered as a single tablet combination at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 days cycle. Dose titration from 5 mg dapagliflozin + 500 mg metformin XR orally once daily to 10 mg dapagliflozin + 2000 mg metformin XR once daily",[9],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Dapagliflozin","Dapagliflozin (tablet) at a starting dose of 5mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 days cycle. Dose titration from 5 mg to 10 mg once daily",[9],[47],{"name":48,"affiliation":48,"role":49},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[51,64],{"facility":52,"status":29,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":29},"Washington Uni School of Med Siteman Cancer Center","St Louis","Missouri","63110","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-90.19789,38.62727,{"lat":62,"lon":61},{"facility":65,"status":29,"city":66,"state":29,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":29},"Novartis Investigative Site","Kuala Lumpur","59100","Malaysia","MY",{"type":59,"coordinates":71},[72,73],101.68653,3.1412,{"lat":73,"lon":72},{"type":76,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100431535","phase-2-study-of-safety-and-efficacy-of-dapagliflozin--metformin-xr-versus-metformin-xr-in-participants-with-hr-her2--advanced-breast-cancer-while-on-treatment-with-alpelisib-and-fulvestrant-100431535",true,"NCT04899349","Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant","EPIK-B4: A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) in Combination With Fulvestrant in Participants With HR+, HER2-, Advanced Breast Cancer With a PIK3CA Mutation Following Progression on\u002FAfter Endocrine-based Therapy","EPIK-B4","Key Inclusion Criteria:\n\n* Participant had a histologically and\u002For cytologically confirmed diagnosis of estrogen receptor positive (ER+) and\u002For progesterone receptor positive (PgR+) breast cancer by a local laboratory.\n* Participant had a PIK3CA mutation(s) present in the tumor prior to enrollment.\n* Participant had prior treatment with an endocrine-based treatment (e.g. letrozole, anastrozole, exemestane, fulvestrant, or oral SERD) and may have fallen into one of the following categories:\n\n  1. Relapsed with documented evidence of progression while on (neo) adjuvant endocrine-based therapy or within 12 months from completion of (neo) adjuvant endocrine-based therapy with no treatment for metastatic disease.\n  2. Relapsed with documented evidence of progression more than 12 months from completion of (neo) adjuvant endocrine-based therapy and then subsequently progressed with documented evidence of progression while on or after only one line of endocrine-based therapy for metastatic disease.\n  3. Newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine-based therapy.\n\nNote: Participants with newly diagnosed endocrine-based treatment naïve advanced breast cancer were NOT included in the study.\n\n* Participants might or might not have received prior CDK4\u002F6i therapy. If prior CDK4\u002F6i therapy was administered, it may have been in the adjuvant or metastatic setting.\n* If female, the participant was postmenopausal.\n* Participant had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant had adequate bone marrow and organ function.\n\nKey Exclusion Criteria:\n\n* Participant relapsed with documented evidence of progression more than 12 months from completion of (neo) adjuvant endocrine therapy with no treatment for metastatic disease.\n* Participant had more than 1 line of prior treatment in the metastatic setting.\n* Participant had received prior treatment with chemotherapy (except for neoadjuvant\u002Fadjuvant chemotherapy), any PI3K, Mammalian Target of Rapamycin (mTOR) or Protein Kinase B (Akt) inhibitor.\n* Participant had inflammatory breast cancer at screening.\n* Participants with an established diagnosis of diabetes mellitus type I or participants with type II diabetes mellitus requiring antihyperglycemic therapy.\n* Participant had a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.\n* Participant had currently documented pneumonitis\u002Finterstitial lung disease.\n* Participant had a history of severe cutaneous reaction, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS).",false,"ALL","18 Years",{"count":89,"type":90},2,"ACTUAL","INTERVENTIONAL",[93],"PHASE2","This study was designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor-2 (HER2)-negative advanced breast cancer with a Phosphoinositide-3-Kinase Catalytic subunit Alpha (PIK3CA) mutation following progression on or after endocrine-based therapy.",[96],"Breast Cancer",[26,31,35,39,98,99,100,101,102,103],"Advanced breast cancer","Phase II","HR+","HER2-","PIK3CA","Hyperglycemia","TERMINATED","Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns","2024-10-07",{"date":108,"type":90},"2024-10-09",{"date":110,"type":90},"2022-04-06",{"date":112,"type":90},"2023-05-10",{"name":48,"class":6}]