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Gene Symbol PTEN
Synonyms 10q23del | BZS | CWS1 | DEC | GLM2 | MHAM | MMAC1 | PTEN1 | PTENbeta | PTENgama | TEP1
Gene Description PTEN, phosphatidylinositol 3,4,5-trisphosphate 3-phosphatase and dual-specificity protein phosphatase PTEN, is a tumor suppressor (PMID: 30562755) with roles in the cell cycle, growth, DNA repair, cell survival and regulation of the Akt-mTOR pathway (PMID: 24656806, PMID: 30145641). PTEN germline mutations are common in Cowden syndrome (PMID: 30562755) and PTEN somatic alterations resulting in loss of function have been found in many types of cancer including, but not limited to endometrial (PMID: 30142194), melanoma (PMID: 30148988), and prostate (PMID: 18767981, PMID: 30153654).
ACMG Incidental List v3.0:
Yes, PTEN hamartoma tumor syndrome (PMID: 34012068)

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01870726 Phase Ib/II Buparlisib + Capmatinib Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Gliobastoma Terminated USA | NLD | ESP | DEU | CHE 0
NCT06239467 Phase I OKI-219 + Trastuzumab OKI-219 Fulvestrant + OKI-219 First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer (PIKture-01) Recruiting USA | FRA | ESP | BEL 1
NCT04493853 Phase III Abiraterone + Capivasertib Abiraterone Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (CAPItello-281) Active, not recruiting USA | TUR | SVK | POL | NLD | ISR | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG 14
NCT04592237 Phase II Niraparib Cabazitaxel + Carboplatin + Cetrelimab Cetrelimab + Niraparib Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer Active, not recruiting USA 0
NCT05038839 Phase I Cabozantinib + Pamiparib Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors Active, not recruiting USA 0
NCT04317105 Phase Ib/II Copanlisib + Ipilimumab + Nivolumab Copanlisib + Nivolumab 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 Active, not recruiting USA | CAN 0
NCT05843253 Phase II Everolimus + Ribociclib Study of Ribociclib and Everolimus in HGG and DIPG Recruiting USA | NLD | GBR | DEU | CAN | AUS 0
NCT02920450 Phase Ib/II Carboplatin + Gedatolisib + Paclitaxel Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) Terminated USA 0
NCT02761694 Phase I ARQ 751 + Paclitaxel ARQ 751 ARQ 751 + Fulvestrant ARQ 751 as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations Terminated USA 0
NCT03317119 Phase I Trametinib + Trifluridine-tipiracil hydrochloride Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery Completed USA 0
NCT04632992 Phase II Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) Completed USA 0
NCT01884285 Phase I AZD8186 Abiraterone + AZD8186 AZD8186 + Vistusertib AZD8186 First Time In Patient Ascending Dose Study Completed USA | GBR | ESP | CAN 0
NCT02189174 Phase Ib/II CLR457 Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies Terminated USA | ESP | CAN 2
NCT01097278 Phase 0 Cholecalciferol S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer Completed USA 0
NCT03218826 Phase I AZD8186 + Docetaxel PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Active, not recruiting USA 0
NCT03209401 Phase I Carboplatin + Niraparib Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies Terminated USA 0
NCT04216472 Phase II Alpelisib + Nab-paclitaxel Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations Active, not recruiting USA 0
NCT04108858 Phase Ib/II Copanlisib + Pertuzumab + Trastuzumab Pertuzumab + Trastuzumab Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer Terminated USA 0
NCT05379972 Phase II Olaparib + Pembrolizumab Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers Recruiting USA 0
NCT03842228 Phase I Copanlisib + Durvalumab + Olaparib Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations Active, not recruiting USA 0
NCT05082025 Phase II Copanlisib + Fulvestrant Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations Active, not recruiting USA 0
NCT04770246 Phase II TAS-117 TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations Terminated USA | GBR | FRA | AUT 0
NCT05010096 Phase I Copanlisib + Elimusertib BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors Withdrawn 0
NCT02401347 Phase II Talazoparib Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors Completed USA 0
NCT06029998 Phase II Bortezomib Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion (BORXPTEN) Recruiting USA 0
NCT06287463 Phase Ib/II DCC-3084 Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway Recruiting USA 0
NCT03207529 Phase I Alpelisib + Enzalutamide Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer Completed USA 0
NCT03065062 Phase I Gedatolisib + Palbociclib Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors Recruiting USA 0
NCT05691465 Phase II lutetium Lu 177 dotatate Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells Recruiting USA 0
NCT00770263 Phase I Erlotinib + Temsirolimus Erlotinib and Temsirolimus for Solid Tumors Completed USA 0
NCT04737109 Phase Ib/II Darolutamide + Ipatasertib Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer Terminated USA 0
NCT05773326 Phase I Temsirolimus Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG Recruiting USA 0
NCT03131908 Phase Ib/II GSK2636771 + Pembrolizumab Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss Active, not recruiting USA 0
NCT01458067 Phase I GSK2636771 A Phase I/IIa, First Time in Human, Study of GSK2636771 in Subjects With Advanced Solid Tumors With Phosphatase and Tensin Homolog (PTEN) Deficiency Completed USA | GBR 1
NCT02576444 Phase II Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib OLAParib COmbinations (OLAPCO) Terminated USA 0
NCT03673787 Phase Ib/II Atezolizumab + Ipatasertib A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) Unknown status GBR 0
NCT05810870 Phase II Eribulin + MEN1611 MEN1611 PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin (SABINA) Recruiting ESP 0
NCT04586270 Phase I TAS0612 A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer Recruiting USA | FRA 0
NCT02987959 Phase II Sapanisertib Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas Terminated USA 0
NCT03834740 Phase I Everolimus + Ribociclib A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection Completed USA 0
NCT06218667 Phase Ib/II Copanlisib + Degarelix A Study of Copanlisib in Combination With Degarelix in People With Prostate Cancer Withdrawn 0
NCT04251533 Phase III Alpelisib + Nab-paclitaxel Nab-paclitaxel Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3) Active, not recruiting USA | TUR | SVN | SVK | POL | NOR | ITA | ISR | HUN | HRV | GBR | FRA | ESP | DEU | CHE | BRA | BGR | AUT | AUS | ARG 10
NCT02215096 Phase I Enzalutamide GSK2636771 Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer Completed USA | GBR 0
NCT03624543 Phase II CFI-400945 CFI-400945 in Patients With Advanced/Metastatic Breast Cancer Active, not recruiting CAN 0
NCT04388852 Phase I DS-3201b + Ipilimumab DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers Recruiting USA 0
NCT04551521 Phase II Atezolizumab Atezolizumab + Ipatasertib Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Cobimetinib Alectinib Atezolizumab + Cobimetinib + Vemurafenib CRAFT: The NCT-PMO-1602 Phase II Trial Recruiting DEU 0
NCT02961283 Phase I ASN003 Study of ASN003 in Subjects With Advanced Solid Tumors Terminated USA 0
NCT02549989 Phase II LY3023414 Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Completed USA 0
NCT05300048 Phase I Serabelisib Nab-paclitaxel + Serabelisib Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations Active, not recruiting USA 0
NCT02523014 Phase II Abemaciclib GSK2256098 Vismodegib Capivasertib Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas Recruiting USA 0
NCT01396408 Phase II Temsirolimus Sunitinib A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours Active, not recruiting CAN 0
NCT04042831 Phase II Olaparib Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations Recruiting USA 0
NCT05933395 Phase II Abemaciclib + Fulvestrant Fulvestrant + Neratinib Alpelisib + Fulvestrant Everolimus + Fulvestrant Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor (GERTRUDE) Recruiting USA 0
NCT01306045 Phase II Erlotinib Lapatinib MK2206 Sunitinib Selumetinib Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies Completed USA 0
NCT01971515 Phase I M2698 First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies Completed USA 0
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting CAN 0
NCT02644122 Phase II SF1126 SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes Terminated USA 0
NCT02315625 Phase II Everolimus Sunitinib Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery Terminated USA 0
NCT01470209 Phase I Buparlisib + Everolimus A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies Completed USA 0
NCT04958226 Phase I Capivasertib + Midazolam A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours Completed USA 0
NCT05768139 Phase Ib/II Fulvestrant + STX-478 STX-478 First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors Recruiting USA | ITA | FRA | ESP 0
NCT03337724 Phase II Ipatasertib + Paclitaxel Paclitaxel A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130) Completed USA | TUR | SVN | POL | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG 13
NCT04774952 Phase I RMC-5552 Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors Active, not recruiting USA 0
NCT01226316 Phase I Capivasertib Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DNK | CAN 2
NCT03207347 Phase II Niraparib A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) Completed USA 0
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Active, not recruiting ITA | GBR | FRA | ESP | BEL 0
NCT03360721 Phase II Abiraterone + Apalutamide + Prednisone Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer Active, not recruiting USA 0