Intervention

Alpelisib

ClinicalTrials.gov intervention label

How to interpret these research links

Connected source records

This is the original ClinicalTrials.gov intervention label, found in 36 distinct published trials. Registry interventions may represent drugs, devices, procedures or other study activities. A matched term or study association does not establish product equivalence, efficacy or regulatory approval.

Data basis: current published ClinicalTrials.gov records and, where present, RxNorm, MONDO and FDA-label identifiers. See the evidence interpretation and counting methodology.

Clinical trials36

Recruiting3

Common conditions25

Lead sponsors shown15

Clinical trials

36 shown

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 InhibitorNCT05933395 · 2024-09-23

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination TherapyNCT05646862 · 2023-06-07

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening TrialNCT05564377 · 2023-04-07

Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.NCT07679269 · 2026-12-15

NOT_YET_RECRUITING

Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment TrialNCT05967286 · 2023-10-23

Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or RibociclibNCT05625087 · 2023-10-19

ACTIVE_NOT_RECRUITING

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating AlpelisibNCT06083038 · 2023-10-05

A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world SettingNCT04967248 · 2023-06-21

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast CancerNCT05101564 · 2023-03-20

SMMART Adaptive Clinical Treatment (ACT) TrialNCT05238831 · 2023-01-30

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast CancerNCT05563220 · 2023-01-24

ACTIVE_NOT_RECRUITING

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)NCT05501886 · 2022-12-08

ACTIVE_NOT_RECRUITING

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast CancerNCT05508906 · 2022-08-31

ACTIVE_NOT_RECRUITING

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.NCT05230810 · 2022-08-25

ACTIVE_NOT_RECRUITING

Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine TreatmentNCT05631795 · 2022-08-09

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 FulvestrantNCT04899349 · 2022-04-06

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast CancerNCT05143229 · 2022-03-28

ACTIVE_NOT_RECRUITING

Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With FulvestrantNCT04862143 · 2022-03-08

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.NCT05038735 · 2021-12-17

ACTIVE_NOT_RECRUITING

Preventing High Blood Sugar in People Being Treated for Metastatic Breast CancerNCT05090358 · 2021-10-08

ACTIVE_NOT_RECRUITING

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)NCT05063786 · 2021-09-14

ACTIVE_NOT_RECRUITING

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast CancerNCT04762979 · 2021-02-12

ACTIVE_NOT_RECRUITING

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast CancerNCT04544189 · 2021-01-20

ACTIVE_NOT_RECRUITING

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast CancerNCT04524000 · 2021-01-08

ACTIVE_NOT_RECRUITING

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.NCT04852081 · 2021-01-01

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC PatientsNCT04300790 · 2020-10-23

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and ImmunotherapyNCT04591431 · 2020-10-07

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA MutationNCT04208178 · 2020-07-16

ACTIVE_NOT_RECRUITING

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN AlterationsNCT04216472 · 2020-07-10

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial CancerNCT04188548 · 2019-12-10

ACTIVE_NOT_RECRUITING

Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast CancerNCT03207529 · 2019-06-07

SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast CancerNCT03386162 · 2018-03-15

Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus FulvestrantNCT03439046 · 2018-02-02

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast CancerNCT03284957 · 2017-09-20

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior TreatmentsNCT03056755 · 2017-08-29

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.NCT02437318 · 2015-07-23

Common conditions

Breast Cancer16 Advanced Breast Cancer6 Anatomic Stage III Breast Cancer AJCC v85 Metastatic Breast Cancer5 Anatomic Stage IV Breast Cancer AJCC v84 Breast Cancer Stage IV3 HER2-negative Breast Cancer3 Advanced Breast Carcinoma2 Advanced Malignant Solid Neoplasm2 Anatomic Stage IIIA Breast Cancer AJCC v82 Anatomic Stage IIIB Breast Cancer AJCC v82 Anatomic Stage IIIC Breast Cancer AJCC v82 Metastatic HER2-Negative Breast Carcinoma2 Prognostic Stage III Breast Cancer AJCC v82 Prognostic Stage IIIA Breast Cancer AJCC v82 Prognostic Stage IIIB Breast Cancer AJCC v82 Prognostic Stage IIIC Breast Cancer AJCC v82 Recurrent Breast Carcinoma2 Recurrent Ovarian Carcinoma2 Refractory Breast Carcinoma2 Triple-Negative Breast Carcinoma2 Unresectable HER2-Negative Breast Carcinoma2 Advanced HER2+Breast Cancer1 Advanced Ovarian Carcinoma1 Advanced Pancreatic Carcinoma1

Leading sponsors

Novartis Pharmaceuticals 12 M.D. Anderson Cancer Center 2 National Cancer Institute (NCI) 2 UNICANCER 2 Blokhin's Russian Cancer Research Center 1 Celcuity Inc 1 Criterium, Inc. 1 Dartmouth-Hitchcock Medical Center 1 Eli Lilly and Company 1 Fondazione per la Medicina Personalizzata 1 HealthPartners Institute 1 Hoffmann-La Roche 1 Jennifer Lee Caswell-Jin 1 Marina N Sharifi 1 MedSIR 1

Trial status mix

ACTIVE_NOT_RECRUITING14

COMPLETED7

TERMINATED7

RECRUITING3

UNKNOWN2

WITHDRAWN2

NOT_YET_RECRUITING1

Phase mix

PHASE220

PHASE17

PHASE37

EARLY_PHASE11

PHASE41

Registry-derived research relationships: ClinicalTrials.gov. Raw condition and intervention labels remain distinct from canonical MONDO/RxNorm entities unless separately normalized.