Clinical Trials

HER2-positive Metastatic Breast Cancer

NCT05022342 2026-02-23

SPEAR

Completed

595 enrolled

Breast Neoplasms

NCT05038735 2026-02-20

EPIK-B5

212 enrolled

Breast Neoplasms

NCT04251533 2026-02-13

EPIK-B3

137 enrolled 21 charts

Triple Negative Breast Neoplasms

NCT05101564 2026-02-12

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

19 enrolled 10 charts

Breast Neoplasms

NCT05501886 2026-02-10

VIKTORIA-1

701 enrolled

Breast Neoplasms, Neoplasm Metastasis

NCT05646862 2026-02-05

INAVO121

420 enrolled

Breast Neoplasms

NCT04208178 2026-02-02

EPIK-B2

19 enrolled

Phase 1/2 Active not recruiting

Advanced HER2+Breast Cancer

NCT01872260 2026-01-30

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

255 enrolled

Breast Neoplasms

NCT03056755 2026-01-13

BYLieve

383 enrolled 16 charts

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT05826964 2026-01-13

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

24 enrolled

Breast Neoplasms

NCT04524000 2026-01-12

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

24 enrolled

Advanced Breast Cancer

NCT05563220 2026-01-06

ELEVATE

Phase 1/2 Recruiting

435 enrolled

Breast Neoplasms

NCT04762979 2026-01-02

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

44 enrolled

Hormone Receptor Positive Breast Carcinoma

NCT06083038 2025-12-31

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

Active not recruiting

15 enrolled

Breast Neoplasms, Hyperglycemia

NCT04967248 2025-12-04

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 Setting

Terminated

4 enrolled

Breast Neoplasms

NCT03284957 2025-11-24

AMEERA-1

Phase 1/2 Terminated

136 enrolled 60 charts

Breast Neoplasms

NCT05090358 2025-10-27

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

15 enrolled

Phase 1 Active not recruiting

Breast Neoplasms

NCT05143229 2025-10-06

ASSET

18 enrolled

Breast Neoplasms, Neoplasm Metastasis

NCT04216472 2025-09-30

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

6 enrolled

Breast Neoplasms, Triple Negative Breast Neoplasms

NCT05392608 2025-09-17

SEQUEL-Breast

130 enrolled

Breast Neoplasms, Genetic Diseases, Inborn

NCT05063786 2025-09-08

ALPHABET

27 enrolled

Breast Neoplasms

NCT05625087 2025-08-20

SAFIR 03

162 enrolled

Breast Neoplasms

NCT04300790 2025-07-29

METALLICA

69 enrolled

BreastEndocrine

Breast Neoplasms, Hyperglycemia, Neoplasm Metastasis, Multiple Endocrine Neoplasia Type 1

NCT05293470 2025-07-09

A Post Marketing Surveillance on Piqray in Korea

Recruiting

900 enrolled

Breast Neoplasms

NCT04544189 2025-06-18

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 Cancer

69 enrolled

Phase 1 Active not recruiting

Breast Neoplasms

NCT04188548 2025-06-04

EMBER

500 enrolled

BreastGynecologic

Breast Neoplasms, Endometrial Neoplasms

NCT02437318 2025-02-13

SOLAR-1

Phase 3 Completed

572 enrolled 22 charts 1 FDA

BreastEndocrine

Breast Neoplasms, Neoplasms, Multiple Endocrine Neoplasia Type 1

NCT03207529 2024-10-10

Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer

18 enrolled

Breast Neoplasms, Triple Negative Breast Neoplasms

NCT04899349 2024-10-09

EPIK-B4

2 enrolled 8 charts

Breast Neoplasms, Hyperglycemia, Hereditary Sensory and Autonomic Neuropathies

NCT05966584 2024-08-29

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

1 enrolled 5 charts

Breast Neoplasms, Exanthema

NCT03439046 2024-08-01

BioItaLEE

Phase 3 Completed

287 enrolled

Phase 1 Active not recruiting

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT01791478 2024-07-23

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

46 enrolled

Breast Neoplasms, Carcinoma, Ductal, Breast

NCT04862143 2024-06-20

TELEPIK

2 enrolled 10 charts

Advanced Breast Cancer

NCT05967286 2024-03-20

Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial

Phase 2 Withdrawn

Phase EARLY_PHASE1 Withdrawn

Anatomic Stage III Breast Cancer AJCC v8

NCT05238831 2024-01-23

SMMART Adaptive Clinical Treatment (ACT) Trial

BreastGastrointestinalGenitourinaryGynecologicSarcoma

Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Sarcoma

NCT01300962 2023-12-04

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

47 enrolled

BreastGastrointestinalThoracic

Breast Neoplasms, Neoplasm Metastasis

NCT04591431 2023-10-03

ROME

Phase 2 Unknown

400 enrolled

Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms

NCT03386162 2022-11-28

SAFIR-PI3K

31 enrolled

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT02506556 2022-08-16

PIKNIC

38 enrolled

Breast Neoplasms

NCT02734615 2022-08-01

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

Phase 1 Terminated

199 enrolled

Advanced or Metastatic ER+ Breast Cancer

NCT02379247 2022-06-07

BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

Phase 1/2 Completed

43 enrolled 18 charts

Breast Neoplasms

NCT03706573 2021-07-19

Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer

No longer available

Breast Neoplasms

NCT02167854 2021-07-09

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

23 enrolled

Breast Neoplasms

NCT04852081 2021-04-21

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

Unknown

1,000 enrolled

Breast Neoplasms

NCT01623349 2021-02-10

Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer

118 enrolled

BreastGynecologic

Breast Neoplasms, Ovarian Neoplasms, Recurrence

NCT02088684 2020-12-17

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

70 enrolled

Breast Neoplasms

NCT01928459 2020-12-09

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

62 enrolled

Acrocephalosyndactylia, Breast Neoplasms

NCT02051751 2020-12-08

A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

19 enrolled

BreastHead & Neck

Breast Neoplasms, Head and Neck Neoplasms, Neoplasms

NCT02077933 2020-12-08

Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors