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    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)
    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
    Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation (ELAINE 3) (NCT05696626)
    Phase 3
    Sermonix Pharmaceuticals Inc.
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    10/31/2023
    Primary completion :
    04/01/2027
    Completion :
    04/01/2028
    ER
    |
    ESR1 mutation
    |
    Verzenio (abemaciclib) • fulvestrant • Fablyn (lasofoxifene)
    First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (STX-478-101) (NCT05768139)
    Phase 1/2
    Scorpion Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    04/17/2023
    Primary completion :
    02/28/2027
    Completion :
    02/28/2029
    PIK3CA
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • STX-478
    A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (SUMIT-BC) (NCT05963984)
    Phase 2
    Carrick Therapeutics Limited
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    12/14/2023
    Primary completion :
    06/30/2025
    Completion :
    12/31/2025
    HER-2 • ER • TP53 • CDK4
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • samuraciclib (CT7001)
    Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer (Dauntless-1) (NCT04115306)
    Phase 1/2
    Phoenix Molecular Designs
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    11/14/2019
    Primary completion :
    12/01/2025
    Completion :
    03/01/2026
    HER-2 • ER
    |
    HER-2 negative
    |
    fulvestrant • PMD-026
    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
    BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (NCT06756932)
    Phase 1
    BeiGene
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    02/04/2025
    Primary completion :
    06/30/2027
    Completion :
    06/30/2027
    BCL2
    |
    fulvestrant • BGB-21447
    Study of Oral MRT-2359 in Selected Cancer Patients (MRT-2359-001) (NCT05546268)
    Phase 1/2
    Monte Rosa Therapeutics, Inc
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    10/12/2022
    Primary completion :
    05/01/2026
    Completion :
    11/01/2027
    MYC • MYCN
    |
    MYCN amplification • MYC expression
    |
    Xtandi (enzalutamide) • fulvestrant • MRT-2359
    BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (NCT06120283)
    Phase 1
    BeiGene
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    12/01/2023
    Primary completion :
    05/01/2026
    Completion :
    05/01/2026
    HER-2
    |
    HER-2 negative
    |
    fulvestrant • letrozole
    Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis (ASPIRE) (NCT03691493)
    Phase 2
    Emory University
    Completed
    Last update posted :
    02/17/2025
    Initiation :
    02/08/2019
    Primary completion :
    10/13/2022
    Completion :
    10/13/2022
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • anastrozole • exemestane • Soltamox (tamoxifen citrate)
    A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors (BG-68501-101) (NCT06257264)
    Phase 1
    BeiGene
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    03/11/2024
    Primary completion :
    02/28/2028
    Completion :
    02/28/2028
    HER-2
    |
    HER-2 negative
    |
    fulvestrant
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (CAAA603B12101) (NCT05870579)
    Phase 1
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    11/13/2023
    Primary completion :
    12/30/2026
    Completion :
    01/26/2032
    HER-2 • ER
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    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)
    A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer (SERENA-2) (NCT04214288)
    Phase 2
    AstraZeneca
    Active, not recruiting
    Last update posted :
    02/14/2025
    Initiation :
    04/22/2020
    Primary completion :
    08/30/2022
    Completion :
    03/28/2025
    HER-2 • ER
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • camizestrant (AZD9833)
    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
    Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients with Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery (NCT02760030)
    Phase 2
    Ohio State University Comprehensive Cancer Center
    Active, not recruiting
    Last update posted :
    02/12/2025
    Initiation :
    02/16/2017
    Primary completion :
    07/31/2025
    Completion :
    07/31/2025
    HER-2 • ER • PGR
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant
    Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial) (NCT05554354)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/12/2025
    Initiation :
    09/13/2024
    Primary completion :
    11/01/2026
    Completion :
    11/01/2026
    HER-2 • ER • PGR • NF1
    |
    HER-2 negative
    |
    Mektovi (binimetinib) • fulvestrant
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (Morpheus-TNBC) (NCT03424005)
    Phase 1/2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    03/30/2018
    Primary completion :
    05/03/2028
    Completion :
    05/03/2028
    HER-2 • PD-L1 • PIK3CA
    |
    PD-L1 expression • PIK3CA mutation
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    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)
    WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor (NCT03854903)
    Phase 1
    Georgetown University
    Completed
    Last update posted :
    02/06/2025
    Initiation :
    04/01/2019
    Primary completion :
    11/01/2023
    Completion :
    01/09/2025
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant • Bosulif (bosutinib)
    Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors (C4391001) (NCT04557449)
    Phase 1
    Pfizer
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    09/23/2020
    Primary completion :
    09/23/2026
    Completion :
    11/23/2027
    CDKN2A • CCND1 • CD4
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Xtandi (enzalutamide) • fulvestrant • letrozole • atirmociclib (PF-07220060) • midazolam hydrochloride
    Study of AVZO-021 in Patients with Advanced Solid Tumors (ARTS-021-1001) (NCT05867251)
    Phase 1/2
    Avenzo Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    08/30/2023
    Primary completion :
    01/31/2028
    Completion :
    01/31/2030
    HER-2 • CCNE1
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • carboplatin • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • Trodelvy (sacituzumab govitecan-hziy) • AVZO-021
    A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (NCT06065748)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/05/2025
    Initiation :
    12/11/2023
    Primary completion :
    07/30/2026
    Completion :
    12/30/2028
    HER-2 • ER • CDK4
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • giredestrant (GDC-9545)
    A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (DESTINY-Breast08) (NCT04556773)
    Phase 1
    AstraZeneca
    Active, not recruiting
    Last update posted :
    02/05/2025
    Initiation :
    12/17/2020
    Primary completion :
    08/16/2023
    Completion :
    12/04/2025
    HER-2 • PGR
    |
    HER-2 expression • HER-2 underexpression • PGR positive
    |
    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
    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)
    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)
    Study of PF-07248144 in Advanced or Metastatic Solid Tumors (C4551001) (NCT04606446)
    Phase 1
    Pfizer
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    11/16/2020
    Primary completion :
    08/13/2025
    Completion :
    03/07/2027
    HER-2 • ER • CDKN2A
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • atirmociclib (PF-07220060) • prifetrastat (PF-07248144)
    Ribociclib and Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR) (NCT05467891)
    Phase 2
    Oana Danciu
    Recruiting
    Last update posted :
    01/31/2025
    Initiation :
    09/13/2022
    Primary completion :
    08/01/2028
    Completion :
    08/01/2029
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    tamoxifen • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane
    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)
    TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (NCT02693535)
    Phase 2
    American Society of Clinical Oncology
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    03/14/2016
    Primary completion :
    06/30/2026
    Completion :
    06/30/2027
    BRAF
    |
    ER positive • HER-2 negative • PGR positive
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Xalkori (crizotinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • Imfinzi (durvalumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • sunitinib • tamoxifen • Perjeta (pertuzumab) • Cotellic (cobimetinib) • Bavencio (avelumab) • Talzenna (talazoparib) • Verzenio (abemaciclib) • albumin-bound paclitaxel • cyclophosphamide • Stivarga (regorafenib) • fulvestrant • Lytgobi (futibatinib) • Tukysa (tucatinib) • Torisel (temsirolimus) • letrozole • Inlyta (axitinib) • epirubicin • anastrozole • exemestane • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • leuprolide acetate for depot suspension
    Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (NCT02778685)
    Phase 2
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    09/30/2016
    Primary completion :
    03/30/2026
    Completion :
    03/30/2026
    HER-2 • ER
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Ibrance (palbociclib) • fulvestrant • letrozole
    Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases (MCC-20899) (NCT04923542)
    Phase 1/2
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    11/30/2021
    Primary completion :
    03/01/2025
    Completion :
    03/01/2026
    HER-2 • ER • PGR
    |
    HER-2 overexpression • HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant
    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 Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3) (NCT04975308)
    Phase 3
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    01/24/2025
    Initiation :
    10/04/2021
    Primary completion :
    06/24/2024
    Completion :
    08/01/2027
    HER-2 • ER
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant • exemestane • Inluriyo (imlunestrant)
    Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) (NCT02947685)
    Phase 3
    Alliance Foundation Trials, LLC.
    Active, not recruiting
    Last update posted :
    01/13/2025
    Initiation :
    06/21/2017
    Primary completion :
    10/15/2024
    Completion :
    07/31/2026
    PIK3CA • PGR
    |
    HER-2 positive • HR positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • anastrozole • exemestane
    Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) (NCT06757634)
    Phase 3
    Celcuity Inc
    Not yet recruiting
    Last update posted :
    01/07/2025
    Initiation :
    06/30/2025
    Primary completion :
    12/31/2027
    Completion :
    12/30/2028
    PIK3CA
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • gedatolisib (PF-05212384)
    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