[{"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":"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":"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":"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":"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":"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":"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":"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":"13809b89-05e8-41ef-8215-b7d1aaa392e9","acronym":"NCI-2018-01880","url":"https://clinicaltrials.gov/study/NCT03884998","created_at":"2021-01-18T19:08:46.177Z","updated_at":"2025-02-25T17:36:15.593Z","phase":"Phase 1","brief_title":"Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma","source_id_and_acronym":"NCT03884998 - NCI-2018-01880","lead_sponsor":"City of Hope Medical Center","biomarkers":" PD-L1","pipe":" | ","alterations":" PD-L1 expression","tags":["PD-L1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Opdivo (nivolumab) • Aliqopa (copanlisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 27","initiation":"Initiation: 02/26/2019","start_date":" 02/26/2019","primary_txt":" Primary completion: 07/16/2025","primary_completion_date":" 07/16/2025","study_txt":" Completion: 07/16/2025","study_completion_date":" 07/16/2025","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":"83a4cc91-840b-45a5-8084-819f697c1e10","acronym":"CA209-8LC","url":"https://clinicaltrials.gov/study/NCT03711058","created_at":"2021-01-18T18:11:36.282Z","updated_at":"2025-02-25T14:27:43.047Z","phase":"Phase 1/2","brief_title":"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","source_id_and_acronym":"NCT03711058 - CA209-8LC","lead_sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","biomarkers":" KRAS • BRAF","pipe":" | ","alterations":" KRAS wild-type • BRAF wild-type • NRAS wild-type","tags":["KRAS • BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e KRAS wild-type • BRAF wild-type • NRAS wild-type"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Opdivo (nivolumab) • Aliqopa (copanlisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 48","initiation":"Initiation: 01/17/2019","start_date":" 01/17/2019","primary_txt":" Primary completion: 06/14/2022","primary_completion_date":" 06/14/2022","study_txt":" Completion: 06/30/2025","study_completion_date":" 06/30/2025","last_update_posted":"2025-01-13"},{"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":"2b3b95d5-ea57-4c3b-b692-eadad885ae68","acronym":"GO39374","url":"https://clinicaltrials.gov/study/NCT03006172","created_at":"2021-01-17T17:17:17.326Z","updated_at":"2025-02-25T12:26:36.051Z","phase":"Phase 1","brief_title":"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","source_id_and_acronym":"NCT03006172 - GO39374","lead_sponsor":"Genentech, 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 Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • metformin • Itovebi (inavolisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 200","initiation":"Initiation: 12/13/2016","start_date":" 12/13/2016","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":"2024-12-20"},{"id":"51bc21f1-64c8-4e95-bcfa-4fdd977e48c0","acronym":"","url":"https://clinicaltrials.gov/study/NCT04572763","created_at":"2021-01-18T21:50:00.501Z","updated_at":"2025-02-25T17:24:50.909Z","phase":"Phase 1/2","brief_title":"Copanlisib Plus Venetoclax in R/R DLBCL","source_id_and_acronym":"NCT04572763","lead_sponsor":"Dana-Farber Cancer Institute","biomarkers":" BCL2 • BCL6","pipe":" | ","alterations":" MYC translocation","tags":["BCL2 • BCL6"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e MYC translocation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Venclexta (venetoclax) • Aliqopa (copanlisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 48","initiation":"Initiation: 09/08/2021","start_date":" 09/08/2021","primary_txt":" Primary completion: 06/01/2025","primary_completion_date":" 06/01/2025","study_txt":" Completion: 09/01/2025","study_completion_date":" 09/01/2025","last_update_posted":"2024-12-20"},{"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":"739a6ead-49a8-4524-b971-bdd0dec1f85b","acronym":"","url":"https://clinicaltrials.gov/study/NCT05082025","created_at":"2021-10-18T12:53:16.001Z","updated_at":"2025-02-25T17:25:18.256Z","phase":"Phase 2","brief_title":"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","source_id_and_acronym":"NCT05082025","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" ER • PIK3CA • PGR • PTEN • PIK3R1 • PI3K","pipe":" | ","alterations":" ER positive • PIK3CA mutation • PTEN deletion","tags":["ER • PIK3CA • PGR • PTEN • PIK3R1 • PI3K"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e ER positive • PIK3CA mutation • PTEN deletion"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e fulvestrant • Aliqopa (copanlisib)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 7","initiation":"Initiation: 09/27/2022","start_date":" 09/27/2022","primary_txt":" Primary completion: 10/29/2026","primary_completion_date":" 10/29/2026","study_txt":" Completion: 10/29/2026","study_completion_date":" 10/29/2026","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":"a6aa62c9-583b-4803-a3ef-71521e4f7978","acronym":"","url":"https://clinicaltrials.gov/study/NCT02390427","created_at":"2021-01-18T11:23:47.971Z","updated_at":"2025-02-25T14:00:36.998Z","phase":"Phase 1","brief_title":"Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer","source_id_and_acronym":"NCT02390427","lead_sponsor":"Otto Metzger, MD","biomarkers":" HER-2","pipe":"","alterations":" ","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • taselisib (GDC-0032)"],"overall_status":"Completed","enrollment":" Enrollment 68","initiation":"Initiation: 04/20/2015","start_date":" 04/20/2015","primary_txt":" Primary completion: 12/01/2022","primary_completion_date":" 12/01/2022","study_txt":" Completion: 07/01/2024","study_completion_date":" 07/01/2024","last_update_posted":"2024-10-02"},{"id":"08e8d834-7d1c-43f8-b2b4-1023ee00f03e","acronym":"X31025","url":"https://clinicaltrials.gov/study/NCT03154294","created_at":"2025-09-13T10:56:31.458Z","updated_at":"2025-09-13T10:56:31.458Z","phase":"Phase 1","brief_title":"Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors","source_id_and_acronym":"NCT03154294 - X31025","lead_sponsor":"Avera McKennan Hospital \u0026 University Health Center","biomarkers":" PI3K","pipe":"","alterations":" ","tags":["PI3K"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e paclitaxel • sapanisertib (CB-228) • serabelisib (MLN1117)"],"overall_status":"Completed","enrollment":" Enrollment 19","initiation":"Initiation: 07/06/2017","start_date":" 07/06/2017","primary_txt":" Primary completion: 11/20/2020","primary_completion_date":" 11/20/2020","study_txt":" Completion: 11/20/2022","study_completion_date":" 11/20/2022","last_update_posted":"2024-07-26"},{"id":"98bf47af-2f07-41d0-8aba-0ad0045bf73a","acronym":"CHRONOS-1","url":"https://clinicaltrials.gov/study/NCT01660451","created_at":"2021-01-18T07:10:10.841Z","updated_at":"2025-02-25T17:20:13.895Z","phase":"Phase 2","brief_title":"Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas","source_id_and_acronym":"NCT01660451 - CHRONOS-1","lead_sponsor":"Bayer","biomarkers":" CD20","pipe":" | ","alterations":" CD20 expression","tags":["CD20"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD20 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Aliqopa (copanlisib)"],"overall_status":"Completed","enrollment":" Enrollment 227","initiation":"Initiation: 11/19/2012","start_date":" 11/19/2012","primary_txt":" Primary completion: 06/22/2016","primary_completion_date":" 06/22/2016","study_txt":" Completion: 05/18/2023","study_completion_date":" 05/18/2023","last_update_posted":"2024-07-17"}]