Drug Pipeline

Alpelisib Clinical Trials

Data updated daily from ClinicalTrials.gov — last refresh 2026-06-12
23
Active Studies
8
Recruiting
5
Phase 3
10
Top Sponsors
1
Changes, 30 Days
What Changed in the Last 30 Days
DetectedTrialChange
2026-06-03 NCT05038735
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants…
Enrollment reduced: 234 -> 210 participants
Active Studies by Phase
Phase 3
4
Phase 2/3
1
Phase 2
13
Phase 1/2
3
Phase 1
2
Active Trials
NCT IDTitleConditionStatus
Phase 3
NCT05501886 Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the… Breast Cancer Active, Not Recruiting
NCT05646862 A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With… Breast Cancer Active, Not Recruiting
NCT04208178 Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance… Advanced HER2+Breast Cancer Active, Not Recruiting
NCT05038735 Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants… Breast Cancer Active, Not Recruiting
Phase 2/3
NCT05948943 Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a… Lymphatic Malformations Recruiting
Phase 2
NCT05933395 Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor Advanced Breast Cancer Recruiting
NCT05577754 Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult… Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP) Recruiting
NCT05983159 A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular… Slow-Flow Vascular Malformation Recruiting
NCT05564377 Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced… Advanced Malignant Solid Neoplasm Recruiting
NCT06997588 EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics… PIK3CA-related Overgrowth Spectrum (PROS) Recruiting
NCT04762979 Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression… Hormone Receptor Positive Breast Carcinoma Active, Not Recruiting
NCT05154487 A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer Endometroid Endometrial Cancer Active, Not Recruiting
NCT04980833 Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With… PIK3CA-related Overgrowth Spectrum (PROS) Active, Not Recruiting
NCT07543822 24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs Vascular Anomalies Active, Not Recruiting
NCT04589650 Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult… PIK3CA-related Overgrowth Spectrum (PROS) Active, Not Recruiting
NCT05392608 SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) Neoplasm, Breast Active, Not Recruiting
NCT04524000 Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in… Advanced Breast Cancer Active, Not Recruiting
NCT04544189 Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant… Breast Neoplasms Active, Not Recruiting
Phase 1/2
NCT05563220 Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various… Breast Cancer Recruiting
NCT05230810 Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic… HER2-positive Metastatic Breast Cancer Active, Not Recruiting
NCT01872260 Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer Breast Cancer Active, Not Recruiting
Phase 1
NCT06354088 Human Models of Selective Insulin Resistance: Alpelisib, Part I Insulin Resistance Recruiting
NCT05143229 Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer Breast Cancer Active, Not Recruiting
Sponsors Running Alpelisib Trials
Disease Areas
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