[{"id":"0cab49cd-f269-4139-a170-355e5106eb01","acronym":"","url":"https://clinicaltrials.gov/study/NCT05564377","created_at":"2022-10-03T15:56:45.241Z","updated_at":"2025-02-25T12:29:02.892Z","phase":"Phase 2","brief_title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","source_id_and_acronym":"NCT05564377","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" BRAF","pipe":"","alterations":" ","tags":["BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Lynparza (olaparib) • Ibrance (palbociclib) • paclitaxel • Vectibix (panitumumab) • Koselugo (selumetinib) • Nerlynx (neratinib) • Piqray (alpelisib) • Lumakras (sotorasib) • Mektovi (binimetinib) • nilotinib • fulvestrant • oxaliplatin • ipatasertib (RG7440) • leucovorin calcium • fluorouracil topical"],"overall_status":"Recruiting","enrollment":" Enrollment 2900","initiation":"Initiation: 04/07/2023","start_date":" 04/07/2023","primary_txt":" Primary completion: 07/01/2030","primary_completion_date":" 07/01/2030","study_txt":" Completion: 07/01/2030","study_completion_date":" 07/01/2030","last_update_posted":"2025-02-24"},{"id":"74157a34-d6de-4ba9-9962-025f2effcf7f","acronym":"ALPHABET","url":"https://clinicaltrials.gov/study/NCT05063786","created_at":"2021-10-01T11:54:26.039Z","updated_at":"2025-02-25T12:37:59.796Z","phase":"Phase 3","brief_title":"Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)","source_id_and_acronym":"NCT05063786 - ALPHABET","lead_sponsor":"Spanish Breast Cancer Research Group","biomarkers":" HER-2 • ER • PIK3CA • PGR","pipe":" | ","alterations":" ER positive • PIK3CA mutation","tags":["HER-2 • ER • PIK3CA • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • capecitabine • Piqray (alpelisib) • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • Navelbine oral (vinorelbine tartrate oral)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 27","initiation":"Initiation: 09/14/2021","start_date":" 09/14/2021","primary_txt":" Primary completion: 06/01/2025","primary_completion_date":" 06/01/2025","study_txt":" Completion: 06/01/2025","study_completion_date":" 06/01/2025","last_update_posted":"2025-02-24"},{"id":"15fc70e8-4f11-459e-b3ee-4470ced3ad18","acronym":"EPIK-B5","url":"https://clinicaltrials.gov/study/NCT05038735","created_at":"2021-09-09T13:53:04.798Z","updated_at":"2025-02-25T14:16:18.971Z","phase":"Phase 3","brief_title":"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.","source_id_and_acronym":"NCT05038735 - EPIK-B5","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" HER-2 • ER • PIK3CA","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • ER • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant"],"overall_status":"Recruiting","enrollment":" Enrollment 234","initiation":"Initiation: 12/17/2021","start_date":" 12/17/2021","primary_txt":" Primary completion: 12/30/2025","primary_completion_date":" 12/30/2025","study_txt":" Completion: 12/29/2027","study_completion_date":" 12/29/2027","last_update_posted":"2025-02-18"},{"id":"accc8beb-5a40-4334-a4ae-f00e0d7cc772","acronym":"ELEVATE","url":"https://clinicaltrials.gov/study/NCT05563220","created_at":"2022-10-03T15:56:32.608Z","updated_at":"2025-02-25T14:17:18.649Z","phase":"Phase 1/2","brief_title":"Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer","source_id_and_acronym":"NCT05563220 - ELEVATE","lead_sponsor":"Stemline Therapeutics, Inc.","biomarkers":" HER-2 • ER • PIK3CA • CDK4","pipe":" | ","alterations":" PIK3CA mutation","tags":["HER-2 • ER • PIK3CA • CDK4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)"],"overall_status":"Recruiting","enrollment":" Enrollment 400","initiation":"Initiation: 01/24/2023","start_date":" 01/24/2023","primary_txt":" Primary completion: 12/27/2026","primary_completion_date":" 12/27/2026","study_txt":" Completion: 12/28/2028","study_completion_date":" 12/28/2028","last_update_posted":"2025-02-18"},{"id":"d4382874-e25d-4b5e-9edf-2da01d094584","acronym":"SOLAR-1","url":"https://clinicaltrials.gov/study/NCT02437318","created_at":"2021-01-17T17:15:58.321Z","updated_at":"2025-02-25T15:10:15.914Z","phase":"Phase 3","brief_title":"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.","source_id_and_acronym":"NCT02437318 - SOLAR-1","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" HER-2 • ER • PIK3CA","pipe":" | ","alterations":" ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive","tags":["HER-2 • ER • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant"],"overall_status":"Completed","enrollment":" Enrollment 572","initiation":"Initiation: 07/23/2015","start_date":" 07/23/2015","primary_txt":" Primary completion: 06/12/2018","primary_completion_date":" 06/12/2018","study_txt":" Completion: 06/09/2023","study_completion_date":" 06/09/2023","last_update_posted":"2025-02-13"},{"id":"030e193e-34f1-4703-8b20-39ecf51033c3","acronym":"EPIK-O","url":"https://clinicaltrials.gov/study/NCT04729387","created_at":"2021-01-28T12:53:14.669Z","updated_at":"2025-02-25T15:19:01.385Z","phase":"Phase 3","brief_title":"Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected","source_id_and_acronym":"NCT04729387 - EPIK-O","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" BRCA","pipe":"","alterations":" ","tags":["BRCA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Lynparza (olaparib) • paclitaxel • Piqray (alpelisib) • pegylated liposomal doxorubicin • doxorubicin liposomal"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 358","initiation":"Initiation: 07/22/2021","start_date":" 07/22/2021","primary_txt":" Primary completion: 04/21/2023","primary_completion_date":" 04/21/2023","study_txt":" Completion: 06/04/2025","study_completion_date":" 06/04/2025","last_update_posted":"2025-02-12"},{"id":"2aac339a-fbd4-48aa-9c04-5e7a6adc7234","acronym":"NCI-MATCH","url":"https://clinicaltrials.gov/study/NCT02465060","created_at":"2021-01-17T17:15:30.769Z","updated_at":"2025-02-25T16:36:36.993Z","phase":"Phase 2","brief_title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)","source_id_and_acronym":"NCT02465060 - NCI-MATCH","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" MSI • CD4","pipe":" | ","alterations":" PD-L1 expression","tags":["MSI • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e 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 • bendamustine • bicalutamide • leucovorin calcium • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Zepzelca (lurbinectedin) • mitomycin • Jingzhuda (entinostat) • Recentin (cediranib) • Trazimera (trastuzumab-qyyp) • melphalan • Fakzynja (defactinib) • GSK2636771 • Zirabev (bevacizumab-bvzr) • 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) • Paletan (pertuzumab biosimilar) • Provenge (sipuleucel-T) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar) • Airuituo (bevacizumab 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) • Pertuvia (pertuzumab biosimilar) • Vasforda (bevacizumab biosimilar) • celecoxib oral • cyclophosphamide intravenous • dexamethasone injection • ieramilimab (LAG525) • levoleucovorin calcium • methotrexate IV • sapitinib (AZD8931)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 6452","initiation":"Initiation: 08/17/2015","start_date":" 08/17/2015","primary_txt":" Primary completion: 12/31/2025","primary_completion_date":" 12/31/2025","study_txt":" Completion: 12/31/2025","study_completion_date":" 12/31/2025","last_update_posted":"2025-02-06"},{"id":"f65dd733-9008-4681-bf13-626c30073cdc","acronym":"SAFIR 03","url":"https://clinicaltrials.gov/study/NCT05625087","created_at":"2022-11-22T15:59:03.927Z","updated_at":"2025-02-25T15:54:42.995Z","phase":"Phase 2","brief_title":"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","source_id_and_acronym":"NCT05625087 - SAFIR 03","lead_sponsor":"UNICANCER","biomarkers":" HER-2 • ER • PIK3CA • PGR","pipe":" | ","alterations":" HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HER-2 overexpression + HR positive","tags":["HER-2 • ER • PIK3CA • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HER-2 overexpression + HR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • triptorelin"],"overall_status":"Recruiting","enrollment":" Enrollment 162","initiation":"Initiation: 10/19/2023","start_date":" 10/19/2023","primary_txt":" Primary completion: 07/01/2028","primary_completion_date":" 07/01/2028","study_txt":" Completion: 06/01/2030","study_completion_date":" 06/01/2030","last_update_posted":"2025-01-30"},{"id":"f1019130-1357-4f9c-93ac-a373d891ebad","acronym":"ReDiscover","url":"https://clinicaltrials.gov/study/NCT05216432","created_at":"2022-02-05T18:28:00.435Z","updated_at":"2025-02-25T17:37:34.946Z","phase":"Phase 1","brief_title":"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","source_id_and_acronym":"NCT05216432 - ReDiscover","lead_sponsor":"Relay Therapeutics, Inc.","biomarkers":" HER-2 • PIK3CA • BRCA1 • BRCA2","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • PIK3CA • BRCA1 • BRCA2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • zovegalisib (RLY-2608) • atirmociclib (PF-07220060)"],"overall_status":"Recruiting","enrollment":" Enrollment 890","initiation":"Initiation: 12/08/2021","start_date":" 12/08/2021","primary_txt":" Primary completion: 12/31/2025","primary_completion_date":" 12/31/2025","study_txt":" Completion: 08/31/2026","study_completion_date":" 08/31/2026","last_update_posted":"2025-01-29"},{"id":"f72d1e94-e1dc-4d45-b89e-32b26275924e","acronym":"INAVO121","url":"https://clinicaltrials.gov/study/NCT05646862","created_at":"2022-12-12T15:00:20.879Z","updated_at":"2025-02-25T17:38:18.344Z","phase":"Phase 3","brief_title":"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","source_id_and_acronym":"NCT05646862 - INAVO121","lead_sponsor":"Hoffmann-La Roche","biomarkers":" HER-2 • PIK3CA • CDK4","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • PIK3CA • CDK4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant • Itovebi (inavolisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 400","initiation":"Initiation: 06/07/2023","start_date":" 06/07/2023","primary_txt":" Primary completion: 03/30/2029","primary_completion_date":" 03/30/2029","study_txt":" Completion: 03/30/2029","study_completion_date":" 03/30/2029","last_update_posted":"2025-01-29"},{"id":"c86caf36-50f7-4e83-bb56-4d558b8c9be3","acronym":"EMBER","url":"https://clinicaltrials.gov/study/NCT04188548","created_at":"2021-01-18T20:25:02.359Z","updated_at":"2025-02-25T13:53:03.697Z","phase":"Phase 1","brief_title":"A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer","source_id_and_acronym":"NCT04188548 - EMBER","lead_sponsor":"Eli Lilly and Company","biomarkers":" ER","pipe":" | ","alterations":" HER-2 negative • EGFR positive","tags":["ER"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • EGFR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • everolimus • Perjeta (pertuzumab) • Piqray (alpelisib) • Verzenio (abemaciclib) • exemestane • Inluriyo (imlunestrant)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 500","initiation":"Initiation: 12/10/2019","start_date":" 12/10/2019","primary_txt":" Primary completion: 06/29/2020","primary_completion_date":" 06/29/2020","study_txt":" Completion: 12/01/2027","study_completion_date":" 12/01/2027","last_update_posted":"2025-01-22"},{"id":"cc069dce-4687-46a1-a32d-18817f1eab5a","acronym":"EPIK-B2","url":"https://clinicaltrials.gov/study/NCT04208178","created_at":"2021-01-18T20:29:44.900Z","updated_at":"2025-02-25T12:27:24.833Z","phase":"Phase 3","brief_title":"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","source_id_and_acronym":"NCT04208178 - EPIK-B2","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" HER-2 • PIK3CA","pipe":" | ","alterations":" HER-2 positive • PIK3CA mutation","tags":["HER-2 • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • Perjeta (pertuzumab) • Piqray (alpelisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 19","initiation":"Initiation: 07/16/2020","start_date":" 07/16/2020","primary_txt":" Primary completion: 12/15/2025","primary_completion_date":" 12/15/2025","study_txt":" Completion: 12/15/2025","study_completion_date":" 12/15/2025","last_update_posted":"2025-01-07"},{"id":"275c0818-1a36-410a-a1ea-bc76bfd490c7","acronym":"GOG-3069","url":"https://clinicaltrials.gov/study/NCT05154487","created_at":"2021-12-13T14:12:34.532Z","updated_at":"2025-02-25T15:54:14.125Z","phase":"Phase 2","brief_title":"A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer","source_id_and_acronym":"NCT05154487 - GOG-3069","lead_sponsor":"GOG Foundation","biomarkers":" ER • PIK3CA • MSI","pipe":" | ","alterations":" PIK3CA mutation","tags":["ER • PIK3CA • MSI"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant"],"overall_status":"Recruiting","enrollment":" Enrollment 51","initiation":"Initiation: 09/11/2024","start_date":" 09/11/2024","primary_txt":" Primary completion: 04/01/2025","primary_completion_date":" 04/01/2025","study_txt":" Completion: 04/01/2026","study_completion_date":" 04/01/2026","last_update_posted":"2024-12-19"},{"id":"829b11a8-2149-49a1-8445-bba09c622fc3","acronym":"","url":"https://clinicaltrials.gov/study/NCT06739395","created_at":"2025-02-26T09:10:09.582Z","updated_at":"2025-02-26T09:10:09.582Z","phase":"Phase 2","brief_title":"Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion","source_id_and_acronym":"NCT06739395","lead_sponsor":"Tianjin Medical University Second Hospital","biomarkers":" BRAF","pipe":"","alterations":" ","tags":["BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Lynparza (olaparib) • Mekinist (trametinib) • Ibrance (palbociclib) • Tafinlar (dabrafenib) • Focus V (anlotinib) • temozolomide • Lenvima (lenvatinib) • Piqray (alpelisib) • pazopanib • Epidaza (chidamide) • Trodelvy (sacituzumab govitecan-hziy) • vebreltinib (APL-101)"],"overall_status":"Recruiting","enrollment":" Enrollment 300","initiation":"Initiation: 11/01/2024","start_date":" 11/01/2024","primary_txt":" Primary completion: 12/31/2026","primary_completion_date":" 12/31/2026","study_txt":" Completion: 05/01/2027","study_completion_date":" 05/01/2027","last_update_posted":"2024-12-18"},{"id":"278a467f-a574-4f60-bfe8-46b39583941f","acronym":"BTCRC-BRE19-409","url":"https://clinicaltrials.gov/study/NCT04762979","created_at":"2021-02-21T13:52:26.673Z","updated_at":"2025-02-25T15:44:20.914Z","phase":"Phase 2","brief_title":"Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer","source_id_and_acronym":"NCT04762979 - BTCRC-BRE19-409","lead_sponsor":"Marina N Sharifi","biomarkers":" HER-2 • PIK3CA","pipe":" | ","alterations":" HER-2 amplification • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative","tags":["HER-2 • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant"],"overall_status":"Recruiting","enrollment":" Enrollment 44","initiation":"Initiation: 02/12/2021","start_date":" 02/12/2021","primary_txt":" Primary completion: 09/01/2025","primary_completion_date":" 09/01/2025","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2024-10-30"},{"id":"61d86a30-55c7-41a4-bec4-37a547f93c03","acronym":"OP-1250-003","url":"https://clinicaltrials.gov/study/NCT05508906","created_at":"2022-08-19T17:10:19.756Z","updated_at":"2025-02-25T15:54:36.272Z","phase":"Phase 1","brief_title":"Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus","source_id_and_acronym":"NCT05508906 - OP-1250-003","lead_sponsor":"Olema Pharmaceuticals, Inc.","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250)"],"overall_status":"Recruiting","enrollment":" Enrollment 155","initiation":"Initiation: 08/31/2022","start_date":" 08/31/2022","primary_txt":" Primary completion: 05/20/2026","primary_completion_date":" 05/20/2026","study_txt":" Completion: 06/30/2026","study_completion_date":" 06/30/2026","last_update_posted":"2024-10-03"},{"id":"846b7653-3cb1-438a-96c1-7360840819e9","acronym":"Amelia-1","url":"https://clinicaltrials.gov/study/NCT05455619","created_at":"2022-07-13T12:56:21.512Z","updated_at":"2024-07-02T16:35:02.003Z","phase":"Phase 1/2","brief_title":"Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Women With a PI3K Alteration and HR+/Her2- Breast Cancer","source_id_and_acronym":"NCT05455619 - Amelia-1","lead_sponsor":"SynDevRx, Inc.","biomarkers":" HER-2 • PIK3CA","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant • evexomostat (SDX-7320)"],"overall_status":"Recruiting","enrollment":" Enrollment 52","initiation":"Initiation: 08/26/2022","start_date":" 08/26/2022","primary_txt":" Primary completion: 03/01/2026","primary_completion_date":" 03/01/2026","study_txt":" Completion: 09/01/2026","study_completion_date":" 09/01/2026","last_update_posted":"2024-05-22"},{"id":"5642ab76-9c2e-4f70-9385-2e2c473badfa","acronym":"CLEE011X2107","url":"https://clinicaltrials.gov/study/NCT01872260","created_at":"2021-01-18T08:23:13.566Z","updated_at":"2024-07-02T16:35:05.345Z","phase":"Phase 1/2","brief_title":"Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer","source_id_and_acronym":"NCT01872260 - CLEE011X2107","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" ER • PGR","pipe":" | ","alterations":" ER positive • PGR positive","tags":["ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • Kisqali (ribociclib) • letrozole"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 255","initiation":"Initiation: 10/22/2013","start_date":" 10/22/2013","primary_txt":" Primary completion: 12/31/2024","primary_completion_date":" 12/31/2024","study_txt":" Completion: 12/31/2024","study_completion_date":" 12/31/2024","last_update_posted":"2024-05-07"},{"id":"7b9fcf32-b81f-465c-b7d4-e29cb3b1da1a","acronym":"","url":"https://clinicaltrials.gov/study/NCT04544189","created_at":"2021-01-18T21:44:16.186Z","updated_at":"2024-07-02T16:35:05.471Z","phase":"Phase 2","brief_title":"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","source_id_and_acronym":"NCT04544189","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" HER-2 • ER • PIK3CA","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • ER • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 69","initiation":"Initiation: 01/20/2021","start_date":" 01/20/2021","primary_txt":" Primary completion: 02/28/2025","primary_completion_date":" 02/28/2025","study_txt":" Completion: 02/28/2025","study_completion_date":" 02/28/2025","last_update_posted":"2024-05-07"},{"id":"e264a041-42a7-43c6-8cea-b309a736c283","acronym":"","url":"https://clinicaltrials.gov/study/NCT05101564","created_at":"2021-11-01T11:52:59.476Z","updated_at":"2024-07-02T16:35:06.853Z","phase":"Phase 2","brief_title":"Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer","source_id_and_acronym":"NCT05101564","lead_sponsor":"Stanford University","biomarkers":" HER-2 • ER • PGR","pipe":" | ","alterations":" ER positive • HER-2 negative","tags":["HER-2 • ER • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant • Truseltiq (infigratinib) • letrozole • zotatifin (eFT226) • amcenestrant (SAR439859) • Soltamox (tamoxifen citrate)"],"overall_status":"Recruiting","enrollment":" Enrollment 150","initiation":"Initiation: 03/20/2023","start_date":" 03/20/2023","primary_txt":" Primary completion: 09/01/2025","primary_completion_date":" 09/01/2025","study_txt":" Completion: 12/01/2026","study_completion_date":" 12/01/2026","last_update_posted":"2024-04-30"},{"id":"78b6125a-a5c5-4d81-93da-53f96c3055b7","acronym":"TIFA","url":"https://clinicaltrials.gov/study/NCT05090358","created_at":"2021-10-22T12:53:12.267Z","updated_at":"2024-07-02T16:35:09.806Z","phase":"Phase 2","brief_title":"Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer","source_id_and_acronym":"NCT05090358 - TIFA","lead_sponsor":"Memorial Sloan Kettering Cancer Center","biomarkers":" HER-2 • PIK3CA","pipe":" | ","alterations":" HR positive • HER-2 negative • PIK3CA mutation • PTEN mutation + HR positive","tags":["HER-2 • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HR positive • HER-2 negative • PIK3CA mutation • PTEN mutation + HR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 15","initiation":"Initiation: 10/08/2021","start_date":" 10/08/2021","primary_txt":" Primary completion: 10/08/2024","primary_completion_date":" 10/08/2024","study_txt":" Completion: 10/08/2024","study_completion_date":" 10/08/2024","last_update_posted":"2024-04-12"},{"id":"ea2d5bda-236b-4252-a552-4af178a4fd25","acronym":"","url":"https://clinicaltrials.gov/study/NCT04216472","created_at":"2021-01-18T20:31:45.945Z","updated_at":"2024-07-02T16:35:09.837Z","phase":"Phase 2","brief_title":"Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations","source_id_and_acronym":"NCT04216472","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" HER-2 • ER • PIK3CA • PGR • PTEN","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation • PTEN mutation","tags":["HER-2 • ER • PIK3CA • PGR • PTEN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation • PTEN mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • albumin-bound paclitaxel"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 8","initiation":"Initiation: 02/05/2020","start_date":" 02/05/2020","primary_txt":" Primary completion: 12/31/2025","primary_completion_date":" 12/31/2025","study_txt":" Completion: 12/31/2025","study_completion_date":" 12/31/2025","last_update_posted":"2024-04-12"},{"id":"b6b913f3-7f35-4ce1-9c9a-7dd7e84a43df","acronym":"BYLieve","url":"https://clinicaltrials.gov/study/NCT03056755","created_at":"2021-01-17T17:15:56.950Z","updated_at":"2024-07-02T16:35:12.604Z","phase":"Phase 2","brief_title":"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","source_id_and_acronym":"NCT03056755 - BYLieve","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" HER-2 • ER • PIK3CA","pipe":" | ","alterations":" HER-2 negative • PIK3CA mutation","tags":["HER-2 • ER • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Piqray (alpelisib) • fulvestrant • letrozole • goserelin acetate • leuprolide acetate for depot suspension"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 379","initiation":"Initiation: 08/14/2017","start_date":" 08/14/2017","primary_txt":" Primary completion: 06/14/2021","primary_completion_date":" 06/14/2021","study_txt":" Completion: 07/17/2025","study_completion_date":" 07/17/2025","last_update_posted":"2024-03-27"},{"id":"3fbcc4ad-a557-4826-93ff-485a91046175","acronym":"","url":"https://clinicaltrials.gov/study/NCT05967286","created_at":"2023-08-01T16:10:19.979Z","updated_at":"2024-07-02T16:35:13.626Z","phase":"Phase 2","brief_title":"Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial","source_id_and_acronym":"NCT05967286","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" HER-2 • ER • PIK3CA • BRCA1 • BRCA2 • BAP1 • FANCA • RAD51B • BRIP1 • RAD51C • RAD50 • RAD51D • BARD1 • FANCF • FANCM • FANCD2 • FANCE • FANCC","pipe":" | ","alterations":" ER positive • HER-2 negative • PIK3CA mutation • ER negative","tags":["HER-2 • ER • PIK3CA • BRCA1 • BRCA2 • BAP1 • FANCA • RAD51B • BRIP1 • RAD51C • RAD50 • RAD51D • BARD1 • FANCF • FANCM • FANCD2 • FANCE • FANCC"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • HER-2 negative • PIK3CA mutation • ER negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Lynparza (olaparib) • Piqray (alpelisib)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 10/23/2023","start_date":" 10/23/2023","primary_txt":" Primary completion: 04/30/2025","primary_completion_date":" 04/30/2025","study_txt":" Completion: 04/30/2025","study_completion_date":" 04/30/2025","last_update_posted":"2024-03-20"}]