[{"id":"fe61e59b-5160-4282-9285-2dc7eac8dfb6","acronym":"","url":"https://clinicaltrials.gov/study/NCT06846099","created_at":"2025-02-27T07:07:42.576Z","updated_at":"2025-02-27T07:07:42.576Z","phase":"Phase 1","brief_title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903","source_id_and_acronym":"NCT06846099","lead_sponsor":"Risen (Suzhou) Pharma Tech Co., Ltd.","biomarkers":" PIK3CA","pipe":" | ","alterations":" PIK3CA mutation","tags":["PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"],"overall_status":"Recruiting","enrollment":" Enrollment 174","initiation":"Initiation: 12/07/2022","start_date":" 12/07/2022","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":"2025-02-25"},{"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":"e3b4bad8-8656-47cc-998e-a5d2146657b6","acronym":"ALCHEMIST Screening","url":"https://clinicaltrials.gov/study/NCT02194738","created_at":"2021-01-18T10:15:39.910Z","updated_at":"2025-02-25T12:26:10.714Z","phase":"","brief_title":"Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)","source_id_and_acronym":"NCT02194738 - ALCHEMIST Screening","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" EGFR • PD-L1 • ALK • PIK3CA • PTEN • PD-1 • CTLA4","pipe":" | ","alterations":" EGFR mutation • ALK rearrangement","tags":["EGFR • PD-L1 • ALK • PIK3CA • PTEN • PD-1 • CTLA4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e EGFR mutation • ALK rearrangement"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • Opdivo (nivolumab) • Lynparza (olaparib) • cisplatin • Xalkori (crizotinib) • erlotinib • carboplatin • gemcitabine • paclitaxel • docetaxel • Mektovi (binimetinib) • pemetrexed • sapanisertib (CB-228) • Zaltrap (ziv-aflibercept IV) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar) • Pembroria (pembrolizumab biosimilar) • Pemfexy (pemetrexed) • liposomal gemcitabine (FF-10832)"],"overall_status":"Recruiting","enrollment":" Enrollment 8300","initiation":"Initiation: 09/26/2014","start_date":" 09/26/2014","primary_txt":" Primary completion: 09/28/2026","primary_completion_date":" 09/28/2026","study_txt":" Completion: 09/28/2026","study_completion_date":" 09/28/2026","last_update_posted":"2025-02-24"},{"id":"9563a22f-1431-499b-ba51-cc38d3b74ea7","acronym":"","url":"https://clinicaltrials.gov/study/NCT04345913","created_at":"2021-01-18T21:01:42.609Z","updated_at":"2025-02-25T13:40:07.851Z","phase":"Phase 1/2","brief_title":"Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer","source_id_and_acronym":"NCT04345913","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" ER • PIK3CA • PGR • PTEN","pipe":" | ","alterations":" HER-2 amplification • HER-2 negative • PIK3CA mutation","tags":["ER • PIK3CA • PGR • PTEN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification • HER-2 negative • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Halaven (eribulin mesylate) • Aliqopa (copanlisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 106","initiation":"Initiation: 03/01/2021","start_date":" 03/01/2021","primary_txt":" Primary completion: 06/30/2025","primary_completion_date":" 06/30/2025","study_txt":" Completion: 06/30/2025","study_completion_date":" 06/30/2025","last_update_posted":"2025-02-21"},{"id":"ed7a2006-5e7e-462b-a374-549a902e3ba9","acronym":"STX-478-101","url":"https://clinicaltrials.gov/study/NCT05768139","created_at":"2024-01-30T16:19:49.137Z","updated_at":"2025-02-25T13:41:27.084Z","phase":"Phase 1/2","brief_title":"First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors","source_id_and_acronym":"NCT05768139 - STX-478-101","lead_sponsor":"Scorpion Therapeutics, Inc.","biomarkers":" PIK3CA","pipe":" | ","alterations":" PIK3CA mutation","tags":["PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • tersolisib (LY4064809)"],"overall_status":"Recruiting","enrollment":" Enrollment 400","initiation":"Initiation: 04/17/2023","start_date":" 04/17/2023","primary_txt":" Primary completion: 02/28/2027","primary_completion_date":" 02/28/2027","study_txt":" Completion: 02/28/2029","study_completion_date":" 02/28/2029","last_update_posted":"2025-02-21"},{"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":"09faeec2-6d19-4e99-bfa8-ce9ad5372038","acronym":"","url":"https://clinicaltrials.gov/study/NCT05843253","created_at":"2023-05-06T15:04:11.203Z","updated_at":"2025-02-25T14:09:40.595Z","phase":"Phase 2","brief_title":"Study of Ribociclib and Everolimus in HGG and DIPG","source_id_and_acronym":"NCT05843253","lead_sponsor":"Nationwide Children's Hospital","biomarkers":" PIK3CA • PTEN • CDKN2A • RB1 • CCND1 • CDK4 • CDKN2B • PIK3R1 • CDK6 • CCND2 • CDKN2C","pipe":" | ","alterations":" PIK3CA mutation • CDKN2A deletion","tags":["PIK3CA • PTEN • CDKN2A • RB1 • CCND1 • CDK4 • CDKN2B • PIK3R1 • CDK6 • CCND2 • CDKN2C"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation • CDKN2A deletion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e everolimus • Kisqali (ribociclib)"],"overall_status":"Recruiting","enrollment":" Enrollment 100","initiation":"Initiation: 08/22/2024","start_date":" 08/22/2024","primary_txt":" Primary completion: 08/28/2028","primary_completion_date":" 08/28/2028","study_txt":" Completion: 08/28/2034","study_completion_date":" 08/28/2034","last_update_posted":"2025-02-17"},{"id":"ea690cf4-a21c-4998-8096-bc622dfec937","acronym":"GeparPiPPa","url":"https://clinicaltrials.gov/study/NCT05306041","created_at":"2022-03-31T16:52:51.318Z","updated_at":"2025-02-25T14:16:47.877Z","phase":"Phase 2","brief_title":"Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer","source_id_and_acronym":"NCT05306041 - GeparPiPPa","lead_sponsor":"German Breast Group","biomarkers":" HER-2 • PIK3CA • PGR","pipe":" | ","alterations":" HER-2 positive • PIK3CA mutation • PGR positive","tags":["HER-2 • PIK3CA • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • PIK3CA mutation • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • tamoxifen • Perjeta (pertuzumab) • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)"],"overall_status":"Recruiting","enrollment":" Enrollment 170","initiation":"Initiation: 01/02/2023","start_date":" 01/02/2023","primary_txt":" Primary completion: 10/01/2026","primary_completion_date":" 10/01/2026","study_txt":" Completion: 01/01/2027","study_completion_date":" 01/01/2027","last_update_posted":"2025-02-17"},{"id":"086bd3e8-00e3-4652-8096-301cc6035c9e","acronym":"INAVO122","url":"https://clinicaltrials.gov/study/NCT05894239","created_at":"2023-06-09T09:09:03.004Z","updated_at":"2025-02-25T14:42:07.222Z","phase":"Phase 3","brief_title":"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","source_id_and_acronym":"NCT05894239 - INAVO122","lead_sponsor":"Hoffmann-La Roche","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 tamoxifen • fulvestrant • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)"],"overall_status":"Recruiting","enrollment":" Enrollment 230","initiation":"Initiation: 07/28/2023","start_date":" 07/28/2023","primary_txt":" Primary completion: 09/28/2026","primary_completion_date":" 09/28/2026","study_txt":" Completion: 12/28/2032","study_completion_date":" 12/28/2032","last_update_posted":"2025-02-14"},{"id":"d94f7980-52bd-4422-b97d-6ffc7470ef49","acronym":"NRG-GY031","url":"https://clinicaltrials.gov/study/NCT05950464","created_at":"2023-07-20T15:09:28.523Z","updated_at":"2025-02-25T14:42:14.385Z","phase":"Phase 1","brief_title":"Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer","source_id_and_acronym":"NCT05950464 - NRG-GY031","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" PIK3CA • MSI • MYC • ARID1A • MUC16 • HEXIM1","pipe":" | ","alterations":" MSI-H/dMMR","tags":["PIK3CA • MSI • MYC • ARID1A • MUC16 • HEXIM1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MSI-H/dMMR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ZEN-3694 • tuvusertib (M1774)"],"overall_status":"Recruiting","enrollment":" Enrollment 60","initiation":"Initiation: 12/18/2023","start_date":" 12/18/2023","primary_txt":" Primary completion: 04/30/2026","primary_completion_date":" 04/30/2026","study_txt":" Completion: 04/30/2026","study_completion_date":" 04/30/2026","last_update_posted":"2025-02-14"},{"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":"424f1715-a08a-4e86-a255-1bc30e3c69e6","acronym":"","url":"https://clinicaltrials.gov/study/NCT03203525","created_at":"2021-01-18T15:47:47.088Z","updated_at":"2025-02-25T15:42:56.837Z","phase":"Phase 1","brief_title":"Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer","source_id_and_acronym":"NCT03203525","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" PIK3CA • PTEN","pipe":" | ","alterations":" PIK3CA mutation","tags":["PIK3CA • PTEN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • temsirolimus • pegylated liposomal doxorubicin • leucovorin calcium • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin) • fluorouracil topical • Airuituo (bevacizumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • Vasforda (bevacizumab biosimilar) • doxorubicin liposomal"],"overall_status":"Recruiting","enrollment":" Enrollment 52","initiation":"Initiation: 06/23/2020","start_date":" 06/23/2020","primary_txt":" Primary completion: 12/31/2026","primary_completion_date":" 12/31/2026","study_txt":" Completion: 12/31/2026","study_completion_date":" 12/31/2026","last_update_posted":"2025-02-10"},{"id":"757c7ea9-28ea-4973-bbc9-a09748839d13","acronym":"","url":"https://clinicaltrials.gov/study/NCT05039801","created_at":"2021-09-10T16:57:15.373Z","updated_at":"2025-02-25T15:35:16.395Z","phase":"Phase 1","brief_title":"IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors","source_id_and_acronym":"NCT05039801","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" PD-L1 • PIK3CA • PTEN • STK11 • ARID1A • NF1 • KEAP1 • PD-1 • NFE2L2","pipe":" | ","alterations":" PIK3CA mutation • ARID1A mutation • STK11 mutation • KEAP1 mutation • NFE2L2 mutation","tags":["PD-L1 • PIK3CA • PTEN • STK11 • ARID1A • NF1 • KEAP1 • PD-1 • NFE2L2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation • ARID1A mutation • STK11 mutation • KEAP1 mutation • NFE2L2 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • Avastin (bevacizumab) • paclitaxel • Truqap (capivasertib) • IPN60090"],"overall_status":"Recruiting","enrollment":" Enrollment 54","initiation":"Initiation: 09/09/2021","start_date":" 09/09/2021","primary_txt":" Primary completion: 05/29/2026","primary_completion_date":" 05/29/2026","study_txt":" Completion: 05/29/2026","study_completion_date":" 05/29/2026","last_update_posted":"2025-02-10"},{"id":"f6a27acf-7978-4c4b-a907-56c547d54b2a","acronym":"Morpheus-TNBC","url":"https://clinicaltrials.gov/study/NCT03424005","created_at":"2021-01-18T16:53:25.262Z","updated_at":"2025-02-25T15:17:38.740Z","phase":"Phase 1/2","brief_title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","source_id_and_acronym":"NCT03424005 - Morpheus-TNBC","lead_sponsor":"Hoffmann-La Roche","biomarkers":" HER-2 • PD-L1 • PIK3CA","pipe":" | ","alterations":" PD-L1 expression • PIK3CA mutation","tags":["HER-2 • PD-L1 • PIK3CA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression • PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e 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)"],"overall_status":"Recruiting","enrollment":" Enrollment 580","initiation":"Initiation: 03/30/2018","start_date":" 03/30/2018","primary_txt":" Primary completion: 05/03/2028","primary_completion_date":" 05/03/2028","study_txt":" Completion: 05/03/2028","study_completion_date":" 05/03/2028","last_update_posted":"2025-02-10"},{"id":"56dc1b56-646f-4648-9e26-4b51bc644b50","acronym":"","url":"https://clinicaltrials.gov/study/NCT04317105","created_at":"2021-01-18T20:55:21.759Z","updated_at":"2025-02-25T16:37:48.003Z","phase":"Phase 1/2","brief_title":"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","source_id_and_acronym":"NCT04317105","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" PD-L1 • PIK3CA • PTEN","pipe":" | ","alterations":" PIK3CA mutation","tags":["PD-L1 • PIK3CA • PTEN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 102","initiation":"Initiation: 07/17/2020","start_date":" 07/17/2020","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":"2025-02-06"},{"id":"5351b2fd-adc5-41e4-92bd-076122f48c07","acronym":"BRI-ROL-001","url":"https://clinicaltrials.gov/study/NCT03328026","created_at":"2021-01-18T16:26:04.427Z","updated_at":"2025-02-25T16:52:02.280Z","phase":"Phase 1/2","brief_title":"Combination Study of SV-BR-1-GM With Retifanlimab","source_id_and_acronym":"NCT03328026 - BRI-ROL-001","lead_sponsor":"BriaCell Therapeutics Corporation","biomarkers":" ER • PIK3CA • PGR","pipe":" | ","alterations":" HER-2 positive • HER-2 negative • PGR positive","tags":["ER • PIK3CA • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 positive • HER-2 negative • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cyclophosphamide • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • Bria-IMT (SV-BR-1-GM) • Intron A (interferon α-2b) • cyclophosphamide intravenous"],"overall_status":"Enrolling by invitation","enrollment":" Enrollment 36","initiation":"Initiation: 03/16/2018","start_date":" 03/16/2018","primary_txt":" Primary completion: 11/03/2025","primary_completion_date":" 11/03/2025","study_txt":" Completion: 11/30/2028","study_completion_date":" 11/30/2028","last_update_posted":"2025-02-04"},{"id":"c392c236-bf01-4f33-b758-84c02e4596c3","acronym":"","url":"https://clinicaltrials.gov/study/NCT03939897","created_at":"2021-01-18T19:24:01.905Z","updated_at":"2025-02-25T16:52:29.645Z","phase":"Phase 1","brief_title":"Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer","source_id_and_acronym":"NCT03939897","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" HER-2 • ER • PIK3CA • PGR • PTEN","pipe":" | ","alterations":" HER-2 amplification • HER-2 negative • PGR positive","tags":["HER-2 • ER • PIK3CA • PGR • PTEN"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification • HER-2 negative • PGR positive"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Verzenio (abemaciclib) • fulvestrant • Aliqopa (copanlisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 24","initiation":"Initiation: 06/17/2020","start_date":" 06/17/2020","primary_txt":" Primary completion: 06/22/2023","primary_completion_date":" 06/22/2023","study_txt":" Completion: 07/16/2025","study_completion_date":" 07/16/2025","last_update_posted":"2025-02-04"},{"id":"e68aa363-173c-41d7-9980-c990251d80c6","acronym":"INAVO120","url":"https://clinicaltrials.gov/study/NCT04191499","created_at":"2021-01-18T20:25:45.096Z","updated_at":"2025-02-25T16:52:44.622Z","phase":"Phase 2/3","brief_title":"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","source_id_and_acronym":"NCT04191499 - INAVO120","lead_sponsor":"Hoffmann-La Roche","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 Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 325","initiation":"Initiation: 01/29/2020","start_date":" 01/29/2020","primary_txt":" Primary completion: 09/29/2023","primary_completion_date":" 09/29/2023","study_txt":" Completion: 09/30/2030","study_completion_date":" 09/30/2030","last_update_posted":"2025-02-04"},{"id":"79a21cb0-b80b-4f09-9b9e-bdba02cd1248","acronym":"IMPACT","url":"https://clinicaltrials.gov/study/NCT01505400","created_at":"2021-01-18T06:19:22.670Z","updated_at":"2025-02-25T16:58:29.958Z","phase":"","brief_title":"Integrated Molecular Profiling in Advanced Cancers Trial","source_id_and_acronym":"NCT01505400 - IMPACT","lead_sponsor":"University Health Network, Toronto","biomarkers":" EGFR • HER-2 • PIK3CA • FGFR2 • STK11 • HRAS • PDGFRA • JAK2 • AKT1 • FGFR4 • CTNNB1","pipe":"","alterations":" ","tags":["EGFR • HER-2 • PIK3CA • FGFR2 • STK11 • HRAS • PDGFRA • JAK2 • AKT1 • FGFR4 • CTNNB1"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 3026","initiation":"Initiation: 02/01/2012","start_date":" 02/01/2012","primary_txt":" Primary completion: 01/01/2026","primary_completion_date":" 01/01/2026","study_txt":" Completion: 01/01/2026","study_completion_date":" 01/01/2026","last_update_posted":"2025-02-03"},{"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":"f4599b74-514d-415f-a4c1-0ad32a88ef07","acronym":"A071401","url":"https://clinicaltrials.gov/study/NCT02523014","created_at":"2021-01-18T12:11:52.655Z","updated_at":"2025-02-25T13:11:46.229Z","phase":"Phase 2","brief_title":"Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients with Progressive Meningiomas","source_id_and_acronym":"NCT02523014 - A071401","lead_sponsor":"Alliance for Clinical Trials in Oncology","biomarkers":" PIK3CA • PTEN • CDKN2A • AKT1 • CCND1 • CCNE1 • PTCH1 • CDK4 • NF2 • SMO • CDK6 • CCND2 • CCND3","pipe":" | ","alterations":" PIK3CA mutation • PTEN mutation","tags":["PIK3CA • PTEN • CDKN2A • AKT1 • CCND1 • CCNE1 • PTCH1 • CDK4 • NF2 • SMO • CDK6 • CCND2 • CCND3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PIK3CA mutation • PTEN mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Verzenio (abemaciclib) • Truqap (capivasertib) • Erivedge (vismodegib) • GSK2256098"],"overall_status":"Recruiting","enrollment":" Enrollment 124","initiation":"Initiation: 09/28/2015","start_date":" 09/28/2015","primary_txt":" Primary completion: 01/01/2026","primary_completion_date":" 01/01/2026","study_txt":" Completion: 01/01/2028","study_completion_date":" 01/01/2028","last_update_posted":"2025-01-15"}]