^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Piqray (alpelisib)

    i
    Company:
    Novartis
    Drug class:
    PI3Kα inhibitor
    Related drugs:
    Apply
    Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (NCT05564377)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    04/07/2023
    Primary completion :
    07/01/2030
    Completion :
    07/01/2030
    BRAF
    |
    Lynparza (olaparib) • Ibrance (palbociclib) • paclitaxel • Vectibix (panitumumab) • Koselugo (selumetinib) • Nerlynx (neratinib) • Piqray (alpelisib) • Lumakras (sotorasib) • Mektovi (binimetinib) • Tasigna (nilotinib) • fulvestrant • oxaliplatin • ipatasertib (RG7440) • leucovorin calcium • fluorouracil topical
    Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (NCT05063786)
    Phase 3
    Spanish Breast Cancer Research Group
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    09/14/2021
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • capecitabine • Piqray (alpelisib) • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • Navelbine oral (vinorelbine tartrate oral)
    Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE) (NCT05563220)
    Phase 1/2
    Stemline Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    01/24/2023
    Primary completion :
    12/27/2026
    Completion :
    12/28/2028
    HER-2 • ER • PIK3CA • CDK4
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)
    Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (EPIK-B5) (NCT05038735)
    Phase 3
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    12/17/2021
    Primary completion :
    12/30/2025
    Completion :
    12/29/2027
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    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. (SOLAR-1) (NCT02437318)
    Phase 3
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    02/13/2025
    Initiation :
    07/23/2015
    Primary completion :
    06/12/2018
    Completion :
    06/09/2023
    HER-2 • ER • PIK3CA
    |
    ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
    |
    Piqray (alpelisib) • fulvestrant
    Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected (EPIK-O) (NCT04729387)
    Phase 3
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    02/12/2025
    Initiation :
    07/22/2021
    Primary completion :
    04/21/2023
    Completion :
    06/04/2025
    BRCA
    |
    Lynparza (olaparib) • paclitaxel • Piqray (alpelisib) • pegylated liposomal doxorubicin • doxorubicin liposomal
    Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (NCI-MATCH) (NCT02465060)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    08/17/2015
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    MSI • CD4
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Mekinist (trametinib) • cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • dasatinib • Tafinlar (dabrafenib) • carboplatin • Imfinzi (durvalumab) • Vitrakvi (larotrectinib) • Imbruvica (ibrutinib) • gemcitabine • paclitaxel • Rituxan (rituximab) • docetaxel • 5-fluorouracil • sunitinib • everolimus • Vectibix (panitumumab) • temozolomide • Koselugo (selumetinib) • Perjeta (pertuzumab) • cytarabine • Kadcyla (ado-trastuzumab emtansine) • bortezomib • doxorubicin hydrochloride • Talzenna (talazoparib) • capecitabine • Piqray (alpelisib) • Xtandi (enzalutamide) • azacitidine • Cabometyx (cabozantinib tablet) • Balversa (erdafitinib) • Gazyva (obinutuzumab) • Mektovi (binimetinib) • albumin-bound paclitaxel • cyclophosphamide • Imjudo (tremelimumab-actl) • Cyramza (ramucirumab) • pemetrexed • fulvestrant • oxaliplatin • adavosertib (AZD1775) • etoposide IV • irinotecan • Halaven (eribulin mesylate) • Xpovio (selinexor) • Conmana (icotinib) • Pemazyre (pemigatinib) • Truqap (capivasertib) • methotrexate • Zarnestra (tipifarnib) • Aliqopa (copanlisib) • fexagratinib (ABSK091) • Ninlaro (ixazomib) • pegylated liposomal doxorubicin • epirubicin • sapanisertib (CB-228) • ipatasertib (RG7440) • Caprelsa (vandetanib) • vincristine • vinorelbine tartrate • Cometriq (cabozantinib capsule) • Tabrecta (capmatinib) • spartalizumab (PDR001) • taselisib (GDC-0032) • daunorubicin • omipalisib (GSK2126458) • ulixertinib (BVD-523) • mitoxantrone • Erivedge (vismodegib) • carmustine • bicalutamide • leucovorin calcium • bendamustine • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Zepzelca (lurbinectedin) • mitomycin • Jingzhuda (entinostat) • Recentin (cediranib) • Trazimera (trastuzumab-qyyp) • melphalan • GSK2636771 • Zirabev (bevacizumab-bvzr) • defactinib (VS-6063) • goserelin acetate • Zynyz (retifanlimab-dlwr) • fludarabine IV • Ostarine (enobosarm) • avadomide (CC-122) • vistusertib (AZD2014) • Myocet (non-pegylated liposomal doxorubicin) • mesna • vinblastine • Xofigo (radium Ra-223 dichloride) • lorvotuzumab mertansine (IMGN901) • Ampligen (rintatolimod) • E6201 • Fujovee (abivertinib) • Provenge (sipuleucel-T) • TQB2440 (pertuzumab biosimilar) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar) • Airuituo (bevacizumab biosimilar) • BCD-178 (pertuzumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • CC-90002 • EG1206A (pertuzumab biosimilar) • GB222 (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • ImmuniCell (autologous γδ T lymphocytes) • Leukine (sargramostim) • Vasforda (bevacizumab biosimilar) • celecoxib oral • cyclophosphamide intravenous • dexamethasone injection • ieramilimab (LAG525) • levoleucovorin calcium • methotrexate IV • sapitinib (AZD8931)
    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 Ribociclib (SAFIR 03) (NCT05625087)
    Phase 2
    UNICANCER
    Recruiting
    Last update posted :
    01/30/2025
    Initiation :
    10/19/2023
    Primary completion :
    07/01/2028
    Completion :
    06/01/2030
    HER-2 • ER • PIK3CA • PGR
    |
    HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HER-2 overexpression + HR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • triptorelin
    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 Therapy (INAVO121) (NCT05646862)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    06/07/2023
    Primary completion :
    03/30/2029
    Completion :
    03/30/2029
    HER-2 • PIK3CA • CDK4
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • Itovebi (inavolisib)
    First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer (ReDiscover) (NCT05216432)
    Phase 1
    Relay Therapeutics, Inc.
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    12/08/2021
    Primary completion :
    12/31/2025
    Completion :
    08/31/2026
    HER-2 • PIK3CA • BRCA1 • BRCA2
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • RLY-2608 • atirmociclib (PF-07220060)
    A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (EMBER) (NCT04188548)
    Phase 1
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    01/22/2025
    Initiation :
    12/10/2019
    Primary completion :
    06/29/2020
    Completion :
    12/01/2027
    ER
    |
    HER-2 negative • EGFR positive
    |
    Herceptin (trastuzumab) • everolimus • Perjeta (pertuzumab) • Piqray (alpelisib) • Verzenio (abemaciclib) • exemestane • Inluriyo (imlunestrant)
    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 (EPIK-B2) (NCT04208178)
    Phase 3
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    01/07/2025
    Initiation :
    07/16/2020
    Primary completion :
    12/15/2025
    Completion :
    12/15/2025
    HER-2 • PIK3CA
    |
    HER-2 positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Piqray (alpelisib)
    A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (GOG-3069) (NCT05154487)
    Phase 2
    GOG Foundation
    Recruiting
    Last update posted :
    12/19/2024
    Initiation :
    09/11/2024
    Primary completion :
    04/01/2025
    Completion :
    04/01/2026
    ER • PIK3CA • MSI
    |
    PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion (NCT06739395)
    Phase 2
    Tianjin Medical University Second Hospital
    Recruiting
    Last update posted :
    12/18/2024
    Initiation :
    11/01/2024
    Primary completion :
    12/31/2026
    Completion :
    05/01/2027
    BRAF
    |
    Lynparza (olaparib) • Mekinist (trametinib) • Ibrance (palbociclib) • Tafinlar (dabrafenib) • Focus V (anlotinib) • temozolomide • Lenvima (lenvatinib) • Piqray (alpelisib) • pazopanib • Epidaza (chidamide) • Trodelvy (sacituzumab govitecan-hziy) • bozitinib (APL-101)
    Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer (BTCRC-BRE19-409) (NCT04762979)
    Phase 2
    Marina N Sharifi
    Recruiting
    Last update posted :
    10/30/2024
    Initiation :
    02/12/2021
    Primary completion :
    09/01/2025
    Completion :
    01/01/2026
    HER-2 • PIK3CA
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    Piqray (alpelisib) • fulvestrant
    Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (OP-1250-003) (NCT05508906)
    Phase 1
    Olema Pharmaceuticals, Inc.
    Recruiting
    Last update posted :
    10/03/2024
    Initiation :
    08/31/2022
    Primary completion :
    05/20/2026
    Completion :
    06/30/2026
    HER-2
    |
    HER-2 negative
    |
    everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250)
    Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Women With a PI3K Alteration and HR+/Her2- Breast Cancer (Amelia-1) (NCT05455619)
    Phase 1/2
    SynDevRx, Inc.
    Recruiting
    Last update posted :
    05/22/2024
    Initiation :
    08/26/2022
    Primary completion :
    03/01/2026
    Completion :
    09/01/2026
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • evexomostat (SDX-7320)
    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 (NCT04544189)
    Phase 2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    05/07/2024
    Initiation :
    01/20/2021
    Primary completion :
    02/28/2025
    Completion :
    02/28/2025
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer (CLEE011X2107) (NCT01872260)
    Phase 1/2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    05/07/2024
    Initiation :
    10/22/2013
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    ER • PGR
    |
    ER positive • PGR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • letrozole
    Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer (NCT05101564)
    Phase 2
    Stanford University
    Recruiting
    Last update posted :
    04/30/2024
    Initiation :
    03/20/2023
    Primary completion :
    09/01/2025
    Completion :
    12/01/2026
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative
    |
    Piqray (alpelisib) • fulvestrant • Truseltiq (infigratinib) • letrozole • zotatifin (eFT226) • amcenestrant (SAR439859) • Soltamox (tamoxifen citrate)
    Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations (NCT04216472)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    04/12/2024
    Initiation :
    02/05/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    HER-2 • ER • PIK3CA • PGR • PTEN
    |
    HER-2 negative • PIK3CA mutation • PTEN mutation
    |
    Piqray (alpelisib) • albumin-bound paclitaxel
    Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer (TIFA) (NCT05090358)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    04/12/2024
    Initiation :
    10/08/2021
    Primary completion :
    10/08/2024
    Completion :
    10/08/2024
    HER-2 • PIK3CA
    |
    HR positive • HER-2 negative • PIK3CA mutation • PTEN mutation + HR positive
    |
    Piqray (alpelisib) • fulvestrant
    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 (BYLieve) (NCT03056755)
    Phase 2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    03/27/2024
    Initiation :
    08/14/2017
    Primary completion :
    06/14/2021
    Completion :
    07/17/2025
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • letrozole • goserelin acetate • leuprolide acetate for depot suspension
    Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial (NCT05967286)
    Phase 2
    National Cancer Institute (NCI)
    Withdrawn
    Last update posted :
    03/20/2024
    Initiation :
    10/23/2023
    Primary completion :
    04/30/2025
    Completion :
    04/30/2025
    HER-2 • ER • PIK3CA • BRCA1 • BRCA2 • BAP1 • FANCA • RAD51B • BRIP1 • RAD51C • RAD50 • RAD51D • BARD1 • FANCF • FANCM • FANCD2 • FANCE • FANCC
    |
    ER positive • HER-2 negative • PIK3CA mutation • ER negative
    |
    Lynparza (olaparib) • Piqray (alpelisib)
    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 Treatment (ALPINIST) (NCT05631795)
    Phase 4
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    03/20/2024
    Initiation :
    08/09/2022
    Primary completion :
    11/03/2025
    Completion :
    11/03/2025
    HER-2 • PIK3CA
    |
    HR positive • HER-2 negative • PIK3CA mutation • PTEN mutation + HR positive
    |
    Piqray (alpelisib) • fulvestrant
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (NCT05230810)
    Phase 1/2
    Criterium, Inc.
    Recruiting
    Last update posted :
    03/19/2024
    Initiation :
    08/25/2022
    Primary completion :
    08/30/2024
    Completion :
    06/30/2025
    EGFR • HER-2 • PIK3CA • CD4
    |
    HER-2 positive • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3) (NCT04251533)
    Phase 3
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    02/28/2024
    Initiation :
    06/08/2020
    Primary completion :
    05/31/2023
    Completion :
    09/02/2024
    PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Piqray (alpelisib) • albumin-bound paclitaxel
    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 Fulvestrant (BioItaLEE) (NCT03439046)
    Phase 3
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    02/23/2024
    Initiation :
    02/02/2018
    Primary completion :
    12/11/2023
    Completion :
    12/11/2023
    HER-2 • ER • PIK3CA • PGR • PTEN • CDKN2A • CCND1
    |
    ER positive • HER-2 negative • PIK3CA mutation • PGR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • letrozole
    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 Cancer (AMEERA-1) (NCT03284957)
    Phase 1/2
    Sanofi
    Active, not recruiting
    Last update posted :
    02/12/2024
    Initiation :
    09/20/2017
    Primary completion :
    12/29/2027
    Completion :
    12/29/2027
    HER-2 • ER
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • amcenestrant (SAR439859) • midazolam hydrochloride
    Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) (NCT05660083)
    Phase 2
    The Methodist Hospital Research Institute
    Recruiting
    Last update posted :
    02/07/2024
    Initiation :
    01/12/2023
    Primary completion :
    12/01/2026
    Completion :
    12/02/2028
    HER-2
    |
    HER-2 negative
    |
    Piqray (alpelisib) • albumin-bound paclitaxel • tilarginine (L-NMMA)
    SMMART Adaptive Clinical Treatment (ACT) Trial (NCT05238831)
    Phase 1
    OHSU Knight Cancer Institute
    Withdrawn
    Last update posted :
    01/23/2024
    Initiation :
    01/30/2023
    Primary completion :
    05/31/2026
    Completion :
    05/31/2026
    HER-2 • BRCA1 • BRCA2
    |
    HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • EG1206A (pertuzumab biosimilar)
    Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer (NCT03207529)
    Phase 1
    M.D. Anderson Cancer Center
    Completed
    Last update posted :
    01/11/2024
    Initiation :
    06/07/2019
    Primary completion :
    12/31/2023
    Completion :
    12/31/2023
    HER-2 • ER • PGR • PTEN • AR
    |
    HR positive • HER-2 negative • AR positive • PTEN positive
    |
    Piqray (alpelisib) • Xtandi (enzalutamide)
    BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer (NCT01791478)
    Phase 1
    Vanderbilt-Ingram Cancer Center
    Active, not recruiting
    Last update posted :
    12/05/2023
    Initiation :
    04/01/2013
    Primary completion :
    12/01/2014
    Completion :
    05/31/2024
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • letrozole
    Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer (EPIK-B6) (NCT04524000)
    Phase 2
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    12/05/2023
    Initiation :
    11/20/2020
    Primary completion :
    01/31/2025
    Completion :
    01/31/2025
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer (NCT01300962)
    Phase 1
    UNC Lineberger Comprehensive Cancer Center
    Completed
    Last update posted :
    12/04/2023
    Initiation :
    08/01/2011
    Primary completion :
    02/07/2017
    Completion :
    12/31/2018
    HER-2
    |
    Herceptin (trastuzumab) • lapatinib • capecitabine • Piqray (alpelisib) • buparlisib (AN2025)
    A Post Marketing Surveillance on Piqray in Korea (NCT05293470)
    Phase N/A
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    11/21/2023
    Initiation :
    06/29/2022
    Primary completion :
    05/12/2027
    Completion :
    05/12/2027
    HER-2 • PIK3CA
    |
    EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive
    |
    Piqray (alpelisib)
    Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients (ALCAP) (NCT04753203)
    Phase 1/2
    Korean Cancer Study Group
    Active, not recruiting
    Last update posted :
    10/31/2023
    Initiation :
    02/28/2021
    Primary completion :
    02/28/2024
    Completion :
    02/28/2025
    PIK3CA
    |
    PIK3CA mutation
    |
    capecitabine • Piqray (alpelisib)
    Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor (GERTRUDE) (NCT05933395)
    Phase 2
    Dartmouth-Hitchcock Medical Center
    Recruiting
    Last update posted :
    10/26/2023
    Initiation :
    10/10/2023
    Primary completion :
    10/01/2030
    Completion :
    10/01/2031
    HER-2 • PIK3CA • PTEN • RB1 • AKT1 • mTOR • CDK4
    |
    everolimus • Nerlynx (neratinib) • Piqray (alpelisib) • Verzenio (abemaciclib) • fulvestrant