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    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903 (NCT06846099)
    Phase 1
    Risen (Suzhou) Pharma Tech Co., Ltd.
    Recruiting
    Last update posted :
    02/25/2025
    Initiation :
    12/07/2022
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    PIK3CA
    |
    PIK3CA mutation
    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)
    Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (NCT04345913)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    03/01/2021
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    ER • PIK3CA • PGR • PTEN
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation
    |
    Halaven (eribulin mesylate) • Aliqopa (copanlisib)
    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
    Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer (GeparPiPPa) (NCT05306041)
    Phase 2
    German Breast Group
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/02/2023
    Primary completion :
    10/01/2026
    Completion :
    01/01/2027
    HER-2 • PIK3CA • PGR
    |
    HER-2 positive • PIK3CA mutation • PGR positive
    |
    Herceptin (trastuzumab) • tamoxifen • Perjeta (pertuzumab) • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) (NCT05894239)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    07/28/2023
    Primary completion :
    09/28/2026
    Completion :
    12/28/2032
    HER-2 • PIK3CA
    |
    HER-2 positive • PIK3CA mutation
    |
    tamoxifen • fulvestrant • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    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
    Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (NCT04317105)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    07/17/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    PD-L1 • PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) (NCT04191499)
    Phase 2/3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    01/29/2020
    Primary completion :
    09/29/2023
    Completion :
    09/30/2030
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer (NCT03939897)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    06/17/2020
    Primary completion :
    06/22/2023
    Completion :
    07/16/2025
    HER-2 • ER • PIK3CA • PGR • PTEN
    |
    HER-2 amplification • HER-2 negative • PGR positive
    |
    Verzenio (abemaciclib) • fulvestrant • Aliqopa (copanlisib)
    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)
    Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma (NCI-2018-01880) (NCT03884998)
    Phase 1
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    02/26/2019
    Primary completion :
    07/16/2025
    Completion :
    07/16/2025
    PD-L1
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Aliqopa (copanlisib)
    Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer (CA209-8LC) (NCT03711058)
    Phase 1/2
    Sidney Kimmel Comprehensive Cancer Center at Jo...
    Active, not recruiting
    Last update posted :
    01/13/2025
    Initiation :
    01/17/2019
    Primary completion :
    06/14/2022
    Completion :
    06/30/2025
    KRAS • BRAF
    |
    KRAS wild-type • BRAF wild-type • NRAS wild-type
    |
    Opdivo (nivolumab) • Aliqopa (copanlisib)
    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)
    Copanlisib Plus Venetoclax in R/R DLBCL (NCT04572763)
    Phase 1/2
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    12/20/2024
    Initiation :
    09/08/2021
    Primary completion :
    06/01/2025
    Completion :
    09/01/2025
    BCL2 • BCL6
    |
    MYC translocation
    |
    Venclexta (venetoclax) • Aliqopa (copanlisib)
    To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer (GO39374) (NCT03006172)
    Phase 1
    Genentech, Inc.
    Active, not recruiting
    Last update posted :
    12/20/2024
    Initiation :
    12/13/2016
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • metformin • Itovebi (inavolisib)
    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
    Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations (NCT05082025)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    12/18/2024
    Initiation :
    09/27/2022
    Primary completion :
    10/29/2026
    Completion :
    10/29/2026
    ER • PIK3CA • PGR • PTEN • PIK3R1 • PI3K
    |
    ER positive • PIK3CA mutation • PTEN deletion
    |
    fulvestrant • Aliqopa (copanlisib)
    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 Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer (NCT02390427)
    Phase 1
    Otto Metzger, MD
    Completed
    Last update posted :
    10/02/2024
    Initiation :
    04/20/2015
    Primary completion :
    12/01/2022
    Completion :
    07/01/2024
    HER-2
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • taselisib (GDC-0032)
    Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas (CHRONOS-1) (NCT01660451)
    Phase 2
    Bayer
    Completed
    Last update posted :
    07/17/2024
    Initiation :
    11/19/2012
    Primary completion :
    06/22/2016
    Completion :
    05/18/2023
    CD20
    |
    CD20 expression
    |
    Aliqopa (copanlisib)
    Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma (NCT03502733)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    06/14/2024
    Initiation :
    08/14/2018
    Primary completion :
    07/01/2024
    Completion :
    07/01/2024
    RAD51
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • ABP 206 (nivolumab biosimilar)
    Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT03586661)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    06/11/2024
    Initiation :
    04/29/2019
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    BRCA • MUC16
    |
    BRCA mutation
    |
    Zejula (niraparib) • Aliqopa (copanlisib)
    A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors (NCT05683418)
    Phase 1
    Totus Medicines
    Recruiting
    Last update posted :
    06/10/2024
    Initiation :
    02/15/2023
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    TOS-358
    Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (NCT04939272)
    Phase 1/2
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    06/04/2024
    Initiation :
    06/29/2022
    Primary completion :
    11/23/2024
    Completion :
    11/23/2024
    BCL2 • CD20 • CCND1 • PAX5 • CD5
    |
    Chr t(11;14) • CCND1 overexpression • PAX5 overexpression
    |
    Venclexta (venetoclax) • Aliqopa (copanlisib)
    A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) (NCT05708235)
    Phase 2
    MedSIR
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    04/01/2024
    Primary completion :
    12/30/2028
    Completion :
    12/30/2028
    HER-2 • PIK3CA
    |
    HR positive • HER-2 negative • PIK3CA mutation
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (GDC-9545)
    Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) (NCI-2022-06209) (NCT05490771)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/23/2024
    Initiation :
    06/20/2018
    Primary completion :
    01/06/2021
    Completion :
    12/31/2025
    PIK3CA
    |
    PIK3CA mutation
    |
    Aliqopa (copanlisib)
    Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations (NCI10217) (NCT03842228)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/21/2019
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    PIK3CA • BRCA1 • BRCA2 • RAD51 • FANCA • RAD51B • BRIP1 • RAD51C • CD4 • RAD51D • BARD1 • NBN
    |
    PIK3CA mutation • PTEN mutation • PALB2 mutation • CDK12 mutation • PIK3CA E545 • PIK3CA H1047 • BARD1 mutation • PIK3CA E542 • RAD51 mutation
    |
    Lynparza (olaparib) • Imfinzi (durvalumab) • Aliqopa (copanlisib)
    Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I) (NCT04439175)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/08/2024
    Initiation :
    02/25/2016
    Primary completion :
    11/10/2020
    Completion :
    03/07/2025
    PIK3CA
    |
    PIK3CA mutation
    |
    taselisib (GDC-0032)
    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)
    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
    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
    A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer (BrUOG 360) (NCT04253262)
    Phase 1/2
    Brown University
    Active, not recruiting
    Last update posted :
    04/05/2024
    Initiation :
    04/03/2020
    Primary completion :
    01/01/2027
    Completion :
    01/01/2027
    BRCA1 • BRCA2 • HRD • CDK12 • FANCA • RAD51B • BRIP1 • RAD51C • RAD51D • CHEK1 • BARD1 • RAD54L • FANCL • PPP2R2A
    |
    BRIP1 mutation
    |
    Rubraca (rucaparib) • Aliqopa (copanlisib)
    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