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ClinicalTrials.gov public records Last synced Oct 16, 2026, 2:41 PM EDT

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Showing 1–24 of 77 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: alpelisib Clear all
Completed Phase 3 Interventional Results available

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
View directory record Official record
Conditions
Breast Cancer
Interventions
Fulvestrant, Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
572 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
34
States / cities
Chandler, Arizona • Scottsdale, Arizona • Fayetteville, Arkansas + 31 more
Source: ClinicalTrials.gov public record
Updated Feb 13, 2025 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 2 Interventional Results available

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 Treatments

NCT03056755
View directory record Official record
Conditions
Breast Cancer
Interventions
Alpelisib, Fulvestrant, Letrozole, Goserelin, Leuprolide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years
Enrollment
383 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
25
States / cities
Gilbert, Arizona • Phoenix, Arizona • Anaheim, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jan 13, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Active, not recruiting Phase 2 Interventional

Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

NCT04980833
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 14, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Active, not recruiting Phase 2 Interventional

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

NCT05090358
View directory record Official record
Conditions
Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer
Interventions
Ketogenic Diet, Low Carbohydrate Diet, Alpelisib, Fulvestrant, Canagliflozin
Dietary Supplement · Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
9
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Recruiting Phase 2 Interventional

Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

NCT05660083
View directory record Official record
Conditions
HER2-negative Breast Cancer, Metastatic Breast Cancer, Metaplastic Breast Carcinoma, TNBC - Triple-Negative Breast Cancer
Interventions
L-NMMA
Drug
Lead sponsor
The Methodist Hospital Research Institute
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
3
States / cities
Bethesda, Maryland • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 1 Interventional

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

NCT02167854
View directory record Official record
Conditions
Breast Cancer
Interventions
BYL719, LJM716, TRASTUZUMAB
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2021
U.S. locations
6
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Commack, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 9, 2021 · Synced Oct 16, 2026, 2:41 PM EDT
Recruiting Phase 2 Interventional

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

NCT05933395
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
Fulvestrant, Neratinib, Alpelisib, Everolimus, Abemaciclib
Drug
Lead sponsor
Dartmouth-Hitchcock Medical Center
Other
Eligibility
18 Years and older · Female only
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
1
States / cities
Lebanon, New Hampshire
Source: ClinicalTrials.gov public record
Updated Jan 20, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
No Longer Available No phase listed Expanded access

Compassionate Use of BYL 719 Alpelisib

NCT03941782
View directory record Official record
Conditions
Lymphangioma
Interventions
Alpelisib
Drug
Lead sponsor
New Mexico Cancer Research Alliance
Other
Eligibility
18 Years and older
U.S. locations
1
States / cities
Albuquerque, New Mexico
Source: ClinicalTrials.gov public record
Updated Jan 11, 2024 · Synced Oct 16, 2026, 2:41 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

NCT01872260
View directory record Official record
Conditions
Breast Cancer
Interventions
LEE011, Letrozole, BYL719
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years · Female only
Enrollment
259 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2027
U.S. locations
10
States / cities
San Diego, California • San Francisco, California • Tampa, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Sep 18, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Active, not recruiting Phase 3 Interventional

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

NCT04208178
View directory record Official record
Conditions
Advanced HER2+Breast Cancer
Interventions
Alpelisib, Alpelisib matching Placebo, Trastuzumab, Pertuzumab
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
2
States / cities
Fayetteville, Arkansas • Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Sep 18, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Recruiting Phase 2Phase 3 Interventional

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

NCT05948943
View directory record Official record
Conditions
Lymphatic Malformations
Interventions
Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
0 Years to 100 Years
Enrollment
232 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2033
U.S. locations
18
States / cities
Oakland, California • Orange, California • Palo Alto, California + 13 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Recruiting Phase 1 Interventional

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)

NCT06545682
View directory record Official record
Conditions
Melanoma (Skin Cancer), Breast Cancer, Brain Metastasases
Interventions
Alpelisib + Pembrolizumab
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 6, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 1 Interventional

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

NCT01300962
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
BMK120, Capecitabine, BYL719, Trastuzumab, Lapatinib
Drug
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
2
States / cities
Chapel Hill, North Carolina • Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 4, 2023 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 1Phase 2 Interventional

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

NCT04997902
View directory record Official record
Conditions
HNSCC
Interventions
Tipifarnib, Alpelisib
Drug
Lead sponsor
Kura Oncology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
11
States / cities
Duarte, California • Orlando, Florida • Baltimore, Maryland + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Terminated Phase 3 Interventional Results available

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

NCT04729387
View directory record Official record
Conditions
Ovarian Cancer
Interventions
Alpelisib, Olaparib, Paclitaxel, Pegylated liposomal doxorubicin (PLD)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
358 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
16
States / cities
Phoenix, Arizona • Fort Myers, Florida • West Palm Beach, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 2 Interventional Results available

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

NCT01923168
View directory record Official record
Conditions
Breast Cancer
Interventions
alpelisib, buparlisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
340 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
23
States / cities
Birmingham, Alabama • Fayetteville, Arkansas • Los Angeles, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2018 · Synced Oct 16, 2026, 2:41 PM EDT
Recruiting Phase 1Phase 2 Interventional

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

NCT05768139
View directory record Official record
Conditions
Breast Cancer, Solid Tumors, Adult
Interventions
STX-478, Fulvestrant, Ribociclib, Palbociclib, Letrozole, Anastrozole, Exemestane, Tamoxifen, Abemaciclib, Imlunestrant, Metformin
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
880 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
28
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed No phase listed Observational

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

NCT06083038
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Alpelisib, FreeStyle Libre 2 Continuous Glucose Monitor
Drug · Device
Lead sponsor
HealthPartners Institute
Other
Eligibility
18 Years and older
Enrollment
8 participants
Timeline
2023 – 2026
U.S. locations
1
States / cities
Saint Louis Park, Minnesota
Source: ClinicalTrials.gov public record
Updated May 6, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Active, not recruiting Phase 1 Interventional

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

NCT04188548
View directory record Official record
Conditions
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Endometrial Cancer
Interventions
LY3484356, Abemaciclib, Everolimus, Alpelisib, Trastuzumab, Aromatase Inhibitor (AI), Pertuzumab
Drug
Lead sponsor
Eli Lilly and Company
Industry
Eligibility
18 Years and older
Enrollment
379 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
42
States / cities
Gilbert, Arizona • Phoenix, Arizona • Springdale, Arkansas + 31 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 1 Interventional

Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

NCT02282371
View directory record Official record
Conditions
Head and Neck Squamous Cell Cancer
Interventions
Cetuximab, BYL719, IMRT (Intensity-Modulated Radiation Therapy)
Drug · Radiation
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2021
U.S. locations
6
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Commack, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Oct 26, 2021 · Synced Oct 16, 2026, 2:41 PM EDT
Recruiting Phase 2 Interventional

EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

NCT06997588
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 100 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
9
States / cities
St Louis, Missouri • Chapel Hill, North Carolina • Cincinnati, Ohio + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 1 Interventional

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

NCT01791478
View directory record Official record
Conditions
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Interventions
PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis, pharmacological studies
Drug · Other
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2022
U.S. locations
2
States / cities
Boston, Massachusetts • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Oct 16, 2026, 2:41 PM EDT
Completed Phase 1 Interventional

A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

NCT01449058
View directory record Official record
Conditions
Advanced and Selected Solid Tumors, AML, High Risk and Very High Risk MDS
Interventions
BYL719, MEK162
Drug
Lead sponsor
Array BioPharma
Industry
Eligibility
18 Years and older
Enrollment
139 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
8
States / cities
La Jolla, California • Tampa, Florida • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2017 · Synced Oct 16, 2026, 2:41 PM EDT
Active, not recruiting Phase 2 Interventional Results available

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

NCT04589650
View directory record Official record
Conditions
PIK3CA-related Overgrowth Spectrum (PROS)
Interventions
Alpelisib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
0 Days to 100 Years
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2031
U.S. locations
11
States / cities
San Francisco, California • Aurora, Colorado • St Louis, Missouri + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 7, 2026 · Synced Oct 16, 2026, 2:41 PM EDT