[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488957":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":72,"studyPopulation":11,"armGroups":73,"interventions":92,"overallOfficials":118,"centralContacts":122,"locations":130,"responsibleParty":1988,"collaborators":11,"id":1990,"slug":1991,"hasResults":1992,"nctId":1993,"briefTitle":1994,"officialTitle":1995,"acronym":1996,"eligibilityCriteria":1997,"healthyVolunteers":1992,"sex":1998,"minAge":1999,"maxAge":11,"enrollmentInfo":2000,"targetDuration":11,"studyType":2003,"phases":2004,"briefSummary":2006,"conditions":2007,"keywords":11,"overallStatus":249,"whyStopped":11,"lastUpdateSubmitDate":2009,"lastUpdatePostDateStruct":2010,"startDateStruct":2013,"completionDateStruct":2015,"leadSponsor":2017,"locationsCount":2018},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":11},[9,13,16,19,22,24,26,28,30,32],{"measure":10,"description":11,"timeFrame":12},"Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)",null,"From randomization until disease progression or death due to any cause (up to approximately 64 months)",{"measure":14,"description":11,"timeFrame":15},"Sub-study: Maximum observed Drug Concentration (Cmax) for Midazolam","Day -4 and -3 of Cycle (C) 1, Day (D) 11 and C1D12. A cycle is 28 days.",{"measure":17,"description":11,"timeFrame":18},"Sub-study: Cmax for Bupropion","Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.",{"measure":20,"description":11,"timeFrame":21},"Sub-study: Cmax for Omeprazole","Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.",{"measure":23,"description":11,"timeFrame":21},"Sub-study: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC [0-last]) for Midazolam",{"measure":25,"description":11,"timeFrame":18},"Sub-study: AUC (0-last) for Bupropion",{"measure":27,"description":11,"timeFrame":21},"Sub-study: AUC (0-last) for Omeprazole",{"measure":29,"description":11,"timeFrame":21},"Sub-study: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) for Midazolam",{"measure":31,"description":11,"timeFrame":18},"Sub-study: AUC (0-infinity) for Bupropion",{"measure":33,"description":11,"timeFrame":21},"Sub-study: AUC (0-infinity) for Omeprazole",[35,38,41,43,45,48,51,53,55,57,60,63],{"measure":36,"description":11,"timeFrame":37},"Overall survival (OS)","From randomization until death due to any cause (up to approximately 85 months)",{"measure":39,"description":11,"timeFrame":40},"BICR-Assessed Overall Response Rate (ORR)","Up to approximately 64 months",{"measure":42,"description":11,"timeFrame":40},"BICR-Assessed Best Overall Response (BOR)",{"measure":44,"description":11,"timeFrame":40},"BICR-Assessed Clinical Benefit Rate (CBR)",{"measure":46,"description":11,"timeFrame":47},"BICR-Assessed Duration of Response (DOR)","From CR or PR until disease progression or death due to any cause (up to approximately 64 months)",{"measure":49,"description":11,"timeFrame":50},"Time to Confirmed Deterioration (TTCD) in Pain","Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit (up to approximately 85 months). Each cycle is 28 days.",{"measure":52,"description":11,"timeFrame":50},"TTCD in Physical Functioning",{"measure":54,"description":11,"timeFrame":50},"TTCD in Role Functioning",{"measure":56,"description":11,"timeFrame":50},"TTCD in Global Health Status\u002FQuality of Life (QOL)",{"measure":58,"description":11,"timeFrame":59},"Percentage of Participants with Adverse Events","Day 1 until 30 days after the final dose of study treatment (up to approximately 85 months)",{"measure":61,"description":11,"timeFrame":62},"Plasma Concentration of Inavolisib at Specified Timepoints","Day 1 and 15 of Cycle 1, and Day 1 of Cycles 2 and 3. Each cycle is 28 days.",{"measure":64,"description":11,"timeFrame":65},"Sub-study: Percentage of Participants with Adverse Events","Day -4 until 30 days after the final dose of study treatment (up to approximately 85 months)",{"allocation":67,"interventionModel":68,"interventionModelDescription":11,"primaryPurpose":69,"observationalModel":11,"timePerspective":11,"maskingInfo":70},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":71,"maskingDescription":11,"whoMasked":11},"NONE","The drug-drug interaction (DDI) substudy will evaluate the impact of repeat doses of inavolisib (coadministered with fulvestrant) on single-dose pharmacokinetics of sensitive CYP450 enzyme substrates (midazolam, omeprazole and bupropion) in participants with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after CDK4\u002F6 inhibitor (CDK4\u002F6i) in combination with endocrine therapy (ET).\n\nEnrollment for the substudy is now open to recruitment.",[74,81,86],{"label":75,"type":76,"description":77,"interventionNames":78},"Inavolisib + Fulvestrant","EXPERIMENTAL","Participants will be administered the treatments as outlined in the interventions section.",[79,80],"Drug: Inavolisib","Drug: Fulvestrant",{"label":82,"type":83,"description":77,"interventionNames":84},"Alpelisib + Fulvestrant","ACTIVE_COMPARATOR",[80,85],"Drug: Alpelisib",{"label":87,"type":76,"description":77,"interventionNames":88},"Sub-study: Inavolisib + Fulvestrant + CYP substrates",[79,80,89,90,91],"Drug: Bupropion","Drug: Omeprazole","Drug: Midazolam",[93,98,102,106,110,114],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":11},"DRUG","Inavolisib","Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle of main study and sub-study.",[75,87],{"type":94,"name":99,"description":100,"armGroupLabels":101,"otherNames":11},"Fulvestrant","Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle of main study and sub-study.",[82,75,87],{"type":94,"name":103,"description":104,"armGroupLabels":105,"otherNames":11},"Alpelisib","Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.",[82],{"type":94,"name":107,"description":108,"armGroupLabels":109,"otherNames":11},"Bupropion","Participants will be administered bupropion PO on Day -3 and Day 12 of Cycle 1 of the sub-study.",[87],{"type":94,"name":111,"description":112,"armGroupLabels":113,"otherNames":11},"Omeprazole","Participants will be administered omerprazole PO on Day -4 and Day 11 of Cycle 1 of sub-study.",[87],{"type":94,"name":115,"description":116,"armGroupLabels":117,"otherNames":11},"Midazolam","Participants will be administered midazolam PO on Day -4 and Day 11 of Cycle 1 of sub-study.",[87],[119],{"name":120,"affiliation":5,"role":121},"Clinical Trials","STUDY_DIRECTOR",[123,128],{"name":124,"role":125,"phone":126,"phoneExt":11,"email":127},"Reference Study ID Number: WO43919 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":129,"role":125,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[131,145,155,164,173,182,193,202,212,222,231,241,247,254,260,270,280,290,299,309,319,329,338,348,358,368,377,386,395,404,409,418,428,437,446,455,464,473,482,492,503,507,516,525,531,537,546,555,567,576,585,594,603,613,622,632,642,653,662,671,680,689,698,710,720,730,740,750,755,765,775,785,791,801,809,821,830,840,850,860,869,879,885,891,897,908,917,926,935,941,950,956,965,974,983,992,1001,1010,1016,1025,1034,1045,1054,1063,1072,1081,1090,1099,1110,1119,1128,1137,1146,1155,1164,1173,1182,1191,1200,1209,1218,1230,1240,1249,1259,1269,1279,1288,1298,1308,1318,1328,1340,1346,1356,1362,1367,1373,1382,1387,1396,1407,1418,1427,1436,1445,1454,1463,1472,1481,1492,1501,1510,1514,1523,1533,1542,1551,1560,1566,1575,1581,1587,1593,1599,1605,1611,1623,1633,1643,1651,1660,1669,1675,1681,1690,1699,1708,1719,1728,1737,1746,1750,1754,1765,1774,1783,1792,1802,1808,1817,1826,1835,1841,1850,1856,1865,1874,1878,1889,1898,1907,1916,1925,1934,1943,1952,1961,1970,1979],{"facility":132,"status":133,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":11},"Marin Cancer Care Inc","WITHDRAWN","Greenbrae","California","94904","United States","US",{"type":140,"coordinates":141},"Point",[142,143],-122.5247,37.94854,{"lat":143,"lon":142},{"facility":146,"status":147,"city":148,"state":135,"zip":149,"country":137,"countryCode":138,"cosmosGeoPoint":150,"geoPoint":154,"contacts":11},"Cancer Blood and Specialty Clinic","ACTIVE_NOT_RECRUITING","Los Alamitos","90720",{"type":140,"coordinates":151},[152,153],-118.07256,33.80307,{"lat":153,"lon":152},{"facility":156,"status":147,"city":157,"state":135,"zip":158,"country":137,"countryCode":138,"cosmosGeoPoint":159,"geoPoint":163,"contacts":11},"Los Angeles Cancer Network","Los Angeles","90017-4803",{"type":140,"coordinates":160},[161,162],-118.24368,34.05223,{"lat":162,"lon":161},{"facility":165,"status":133,"city":166,"state":135,"zip":167,"country":137,"countryCode":138,"cosmosGeoPoint":168,"geoPoint":172,"contacts":11},"University of California, Irvine Medical Center","Orange","92868",{"type":140,"coordinates":169},[170,171],-117.85311,33.78779,{"lat":171,"lon":170},{"facility":174,"status":147,"city":175,"state":135,"zip":176,"country":137,"countryCode":138,"cosmosGeoPoint":177,"geoPoint":181,"contacts":11},"UC Davis Comprehensive Cancer Center","Sacramento","95817",{"type":140,"coordinates":178},[179,180],-121.4944,38.58157,{"lat":180,"lon":179},{"facility":183,"status":184,"city":185,"state":186,"zip":187,"country":137,"countryCode":138,"cosmosGeoPoint":188,"geoPoint":192,"contacts":11},"Rocky Mountain Cancer Centers","COMPLETED","Denver","Colorado","80220",{"type":140,"coordinates":189},[190,191],-104.9847,39.73915,{"lat":191,"lon":190},{"facility":194,"status":133,"city":195,"state":186,"zip":196,"country":137,"countryCode":138,"cosmosGeoPoint":197,"geoPoint":201,"contacts":11},"Banner MD Anderson Cancer Center","Greeley","85234",{"type":140,"coordinates":198},[199,200],-104.70913,40.42331,{"lat":200,"lon":199},{"facility":203,"status":133,"city":204,"state":205,"zip":206,"country":137,"countryCode":138,"cosmosGeoPoint":207,"geoPoint":211,"contacts":11},"Eastern CT Hematology and Oncology Associates","Norwich","Connecticut","06360-2740",{"type":140,"coordinates":208},[209,210],-72.07591,41.52426,{"lat":210,"lon":209},{"facility":213,"status":133,"city":214,"state":215,"zip":216,"country":137,"countryCode":138,"cosmosGeoPoint":217,"geoPoint":221,"contacts":11},"Cancer Care Centers of Brevard","Palm Bay","Florida","32901",{"type":140,"coordinates":218},[219,220],-80.58866,28.03446,{"lat":220,"lon":219},{"facility":223,"status":147,"city":224,"state":215,"zip":225,"country":137,"countryCode":138,"cosmosGeoPoint":226,"geoPoint":230,"contacts":11},"Cleveland Clinic Florida","Weston","33331",{"type":140,"coordinates":227},[228,229],-80.39977,26.10037,{"lat":229,"lon":228},{"facility":232,"status":147,"city":233,"state":234,"zip":235,"country":137,"countryCode":138,"cosmosGeoPoint":236,"geoPoint":240,"contacts":11},"Grady Health System","Atlanta","Georgia","30303",{"type":140,"coordinates":237},[238,239],-84.38798,33.749,{"lat":239,"lon":238},{"facility":242,"status":147,"city":233,"state":234,"zip":243,"country":137,"countryCode":138,"cosmosGeoPoint":244,"geoPoint":246,"contacts":11},"Midtown West Medical","30318",{"type":140,"coordinates":245},[238,239],{"lat":239,"lon":238},{"facility":248,"status":249,"city":233,"state":234,"zip":250,"country":137,"countryCode":138,"cosmosGeoPoint":251,"geoPoint":253,"contacts":11},"Emory University Hospital","RECRUITING","30322",{"type":140,"coordinates":252},[238,239],{"lat":239,"lon":238},{"facility":255,"status":147,"city":233,"state":234,"zip":256,"country":137,"countryCode":138,"cosmosGeoPoint":257,"geoPoint":259,"contacts":11},"Winship Cancer Institute at Emory Saint Joseph's Hospital","30342",{"type":140,"coordinates":258},[238,239],{"lat":239,"lon":238},{"facility":261,"status":133,"city":262,"state":263,"zip":264,"country":137,"countryCode":138,"cosmosGeoPoint":265,"geoPoint":269,"contacts":11},"University of Louisville Hospital","Louisville","Kentucky","40202",{"type":140,"coordinates":266},[267,268],-85.75941,38.25424,{"lat":268,"lon":267},{"facility":271,"status":249,"city":272,"state":273,"zip":274,"country":137,"countryCode":138,"cosmosGeoPoint":275,"geoPoint":279,"contacts":11},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":140,"coordinates":276},[277,278],-71.05977,42.35843,{"lat":278,"lon":277},{"facility":281,"status":133,"city":282,"state":283,"zip":284,"country":137,"countryCode":138,"cosmosGeoPoint":285,"geoPoint":289,"contacts":11},"Karmanos Cancer Institute.","Detroit","Michigan","48201",{"type":140,"coordinates":286},[287,288],-83.04575,42.33143,{"lat":288,"lon":287},{"facility":291,"status":184,"city":292,"state":283,"zip":293,"country":137,"countryCode":138,"cosmosGeoPoint":294,"geoPoint":298,"contacts":11},"Cancer & Hematology Centers of Western Michigan","Grand Rapids","49503",{"type":140,"coordinates":295},[296,297],-85.66809,42.96336,{"lat":297,"lon":296},{"facility":300,"status":147,"city":301,"state":302,"zip":303,"country":137,"countryCode":138,"cosmosGeoPoint":304,"geoPoint":308,"contacts":11},"Minnesota Oncology Hematology","Saint Paul","Minnesota","55102",{"type":140,"coordinates":305},[306,307],-93.09327,44.94441,{"lat":307,"lon":306},{"facility":310,"status":133,"city":311,"state":312,"zip":313,"country":137,"countryCode":138,"cosmosGeoPoint":314,"geoPoint":318,"contacts":11},"MD Anderson Cancer Center at Cooper","Camden","New Jersey","08103",{"type":140,"coordinates":315},[316,317],-75.11962,39.92595,{"lat":317,"lon":316},{"facility":320,"status":133,"city":321,"state":322,"zip":323,"country":137,"countryCode":138,"cosmosGeoPoint":324,"geoPoint":328,"contacts":11},"Novant Health Presbyterain Medical Center","Charlotte","North Carolina","28204",{"type":140,"coordinates":325},[326,327],-80.84313,35.22709,{"lat":327,"lon":326},{"facility":330,"status":133,"city":331,"state":322,"zip":332,"country":137,"countryCode":138,"cosmosGeoPoint":333,"geoPoint":337,"contacts":11},"Novant Health Forsyth Medical Center","Winston-Salem","27103",{"type":140,"coordinates":334},[335,336],-80.24422,36.09986,{"lat":336,"lon":335},{"facility":339,"status":133,"city":340,"state":341,"zip":342,"country":137,"countryCode":138,"cosmosGeoPoint":343,"geoPoint":347,"contacts":11},"Gabrail Cancer Center","Canton","Ohio","44718",{"type":140,"coordinates":344},[345,346],-81.37845,40.79895,{"lat":346,"lon":345},{"facility":349,"status":184,"city":350,"state":351,"zip":352,"country":137,"countryCode":138,"cosmosGeoPoint":353,"geoPoint":357,"contacts":11},"Asante Rogue Regional Medical Center","Medford","Oregon","97504-8332",{"type":140,"coordinates":354},[355,356],-122.87559,42.32652,{"lat":356,"lon":355},{"facility":359,"status":133,"city":360,"state":361,"zip":362,"country":137,"countryCode":138,"cosmosGeoPoint":363,"geoPoint":367,"contacts":11},"Bryn Mawr Hospital","Bryn Mawr","Pennsylvania","19010-3121",{"type":140,"coordinates":364},[365,366],-80.08672,40.30396,{"lat":366,"lon":365},{"facility":369,"status":133,"city":370,"state":361,"zip":371,"country":137,"countryCode":138,"cosmosGeoPoint":372,"geoPoint":376,"contacts":11},"St. Lukes Hospital and Health Network","Easton","18045",{"type":140,"coordinates":373},[374,375],-75.22073,40.68843,{"lat":375,"lon":374},{"facility":378,"status":133,"city":379,"state":361,"zip":380,"country":137,"countryCode":138,"cosmosGeoPoint":381,"geoPoint":385,"contacts":11},"Paoli Memorial Hospital","Paoli","19301",{"type":140,"coordinates":382},[383,384],-75.47631,40.04205,{"lat":384,"lon":383},{"facility":387,"status":133,"city":388,"state":361,"zip":389,"country":137,"countryCode":138,"cosmosGeoPoint":390,"geoPoint":394,"contacts":11},"Abramson Cancer Center Chester County Hospital","West Chester","19380",{"type":140,"coordinates":391},[392,393],-75.60804,39.96097,{"lat":393,"lon":392},{"facility":396,"status":133,"city":397,"state":361,"zip":398,"country":137,"countryCode":138,"cosmosGeoPoint":399,"geoPoint":403,"contacts":11},"Lankenau Medical Center, Cancer Center","Wynnewood","19096",{"type":140,"coordinates":400},[401,402],-75.27074,40.00289,{"lat":402,"lon":401},{"facility":405,"status":133,"city":397,"state":361,"zip":398,"country":137,"countryCode":138,"cosmosGeoPoint":406,"geoPoint":408,"contacts":11},"Main Line Health System",{"type":140,"coordinates":407},[401,402],{"lat":402,"lon":401},{"facility":410,"status":133,"city":411,"state":361,"zip":412,"country":137,"countryCode":138,"cosmosGeoPoint":413,"geoPoint":417,"contacts":11},"WellSpan Oncology Research","York","17403",{"type":140,"coordinates":414},[415,416],-76.72774,39.9626,{"lat":416,"lon":415},{"facility":419,"status":133,"city":420,"state":421,"zip":422,"country":137,"countryCode":138,"cosmosGeoPoint":423,"geoPoint":427,"contacts":11},"Texas Oncology West","Amarillo","Texas","79106",{"type":140,"coordinates":424},[425,426],-101.8313,35.222,{"lat":426,"lon":425},{"facility":429,"status":147,"city":430,"state":421,"zip":431,"country":137,"countryCode":138,"cosmosGeoPoint":432,"geoPoint":436,"contacts":11},"Texas Oncology - Dallas Presbyterian Hospital","Dallas","75231",{"type":140,"coordinates":433},[434,435],-96.80667,32.78306,{"lat":435,"lon":434},{"facility":438,"status":133,"city":439,"state":421,"zip":440,"country":137,"countryCode":138,"cosmosGeoPoint":441,"geoPoint":445,"contacts":11},"Texas Tech University Health Sciences Center","El Paso","79905",{"type":140,"coordinates":442},[443,444],-106.48693,31.75872,{"lat":444,"lon":443},{"facility":447,"status":133,"city":448,"state":421,"zip":449,"country":137,"countryCode":138,"cosmosGeoPoint":450,"geoPoint":454,"contacts":11},"Texas Oncology (Flower Mound) - USOR","Flower Mound","75028",{"type":140,"coordinates":451},[452,453],-97.09696,33.01457,{"lat":453,"lon":452},{"facility":456,"status":133,"city":457,"state":421,"zip":458,"country":137,"countryCode":138,"cosmosGeoPoint":459,"geoPoint":463,"contacts":11},"The Center for Cancer and Blood Disorders - Fort Worth","Fort Worth","76104",{"type":140,"coordinates":460},[461,462],-97.32085,32.72541,{"lat":462,"lon":461},{"facility":465,"status":133,"city":466,"state":421,"zip":467,"country":137,"countryCode":138,"cosmosGeoPoint":468,"geoPoint":472,"contacts":11},"Lumi Research","Kingwood","77339",{"type":140,"coordinates":469},[470,471],-95.18349,30.05691,{"lat":471,"lon":470},{"facility":474,"status":133,"city":475,"state":421,"zip":476,"country":137,"countryCode":138,"cosmosGeoPoint":477,"geoPoint":481,"contacts":11},"Texas Oncology McKinney","McKinney","75071",{"type":140,"coordinates":478},[479,480],-96.61527,33.19762,{"lat":480,"lon":479},{"facility":483,"status":133,"city":484,"state":485,"zip":486,"country":137,"countryCode":138,"cosmosGeoPoint":487,"geoPoint":491,"contacts":11},"Kadlec Clinic Hematology and Oncology","Kennewick","Washington","99336-7774",{"type":140,"coordinates":488},[489,490],-119.13723,46.21125,{"lat":490,"lon":489},{"facility":493,"status":184,"city":494,"state":11,"zip":495,"country":496,"countryCode":497,"cosmosGeoPoint":498,"geoPoint":502,"contacts":11},"Centro de Investigaciones Médicas y Desarrollo LC S.R.L","Buenos Aires","C1113AAE","Argentina","AR",{"type":140,"coordinates":499},[500,501],-58.37723,-34.61315,{"lat":501,"lon":500},{"facility":504,"status":147,"city":505,"state":11,"zip":506,"country":496,"countryCode":497,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Centro Oncologico Korben","Ciudad Autonoma Buenos Aires","C1426AGE",{"facility":508,"status":184,"city":509,"state":11,"zip":510,"country":496,"countryCode":497,"cosmosGeoPoint":511,"geoPoint":515,"contacts":11},"Fundacion CORI para la Investigacion y Prevencion del Cancer","La Rioja","F5300COE",{"type":140,"coordinates":512},[513,514],-66.85637,-29.41328,{"lat":514,"lon":513},{"facility":517,"status":147,"city":518,"state":11,"zip":519,"country":496,"countryCode":497,"cosmosGeoPoint":520,"geoPoint":524,"contacts":11},"Instituto de Oncología de Rosario","Rosario","S2000KZE",{"type":140,"coordinates":521},[522,523],-60.63932,-32.94682,{"lat":523,"lon":522},{"facility":526,"status":133,"city":518,"state":11,"zip":527,"country":496,"countryCode":497,"cosmosGeoPoint":528,"geoPoint":530,"contacts":11},"Sanatorio Parque S.A.","S2000QGB",{"type":140,"coordinates":529},[522,523],{"lat":523,"lon":522},{"facility":532,"status":147,"city":518,"state":11,"zip":533,"country":496,"countryCode":497,"cosmosGeoPoint":534,"geoPoint":536,"contacts":11},"Hosp Provincial D. 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Hospital","Chiang Mai","50200",{"type":140,"coordinates":1770},[1771,1772],98.98468,18.79038,{"lat":1772,"lon":1771},{"facility":1775,"status":133,"city":1776,"state":11,"zip":1777,"country":1758,"countryCode":1759,"cosmosGeoPoint":1778,"geoPoint":1782,"contacts":11},"Chulabhorn Hospital","Lak Si","10210",{"type":140,"coordinates":1779},[1780,1781],100.5792,13.88724,{"lat":1781,"lon":1780},{"facility":1784,"status":133,"city":1785,"state":11,"zip":1786,"country":1758,"countryCode":1759,"cosmosGeoPoint":1787,"geoPoint":1791,"contacts":11},"Songklanagarind Hospital","Songkhla","90110",{"type":140,"coordinates":1788},[1789,1790],100.5951,7.19882,{"lat":1790,"lon":1789},{"facility":1793,"status":147,"city":1794,"state":11,"zip":1795,"country":1796,"countryCode":11,"cosmosGeoPoint":1797,"geoPoint":1801,"contacts":11},"Gulhane Training and Applicaton Hospital","Ankara","06010","Turkey (Türkiye)",{"type":140,"coordinates":1798},[1799,1800],32.85427,39.91987,{"lat":1800,"lon":1799},{"facility":1803,"status":147,"city":1794,"state":11,"zip":1804,"country":1796,"countryCode":11,"cosmosGeoPoint":1805,"geoPoint":1807,"contacts":11},"Memorial Ankara Hastanesi","06520",{"type":140,"coordinates":1806},[1799,1800],{"lat":1800,"lon":1799},{"facility":1809,"status":184,"city":1810,"state":11,"zip":1811,"country":1796,"countryCode":11,"cosmosGeoPoint":1812,"geoPoint":1816,"contacts":11},"Dicle University Faculty of Medicine","Diyarbakır","21280",{"type":140,"coordinates":1813},[1814,1815],40.21721,37.91363,{"lat":1815,"lon":1814},{"facility":1818,"status":147,"city":1819,"state":11,"zip":1820,"country":1796,"countryCode":11,"cosmosGeoPoint":1821,"geoPoint":1825,"contacts":11},"Trakya University Medical Faculty","Edirne","22030",{"type":140,"coordinates":1822},[1823,1824],26.55597,41.67719,{"lat":1824,"lon":1823},{"facility":1827,"status":184,"city":1828,"state":11,"zip":1829,"country":1796,"countryCode":11,"cosmosGeoPoint":1830,"geoPoint":1834,"contacts":11},"Medipol Mega Üniversite Hastanesi Göztepe","Istanbul","34214",{"type":140,"coordinates":1831},[1832,1833],28.94966,41.01384,{"lat":1833,"lon":1832},{"facility":1836,"status":184,"city":1828,"state":11,"zip":1837,"country":1796,"countryCode":11,"cosmosGeoPoint":1838,"geoPoint":1840,"contacts":11},"Marmara Uni Faculty of Medicine","34890",{"type":140,"coordinates":1839},[1832,1833],{"lat":1833,"lon":1832},{"facility":1842,"status":147,"city":1843,"state":11,"zip":1844,"country":1796,"countryCode":11,"cosmosGeoPoint":1845,"geoPoint":1849,"contacts":11},"Ege Uni Medical Faculty Hospital","Izmir","35100",{"type":140,"coordinates":1846},[1847,1848],27.13838,38.41273,{"lat":1848,"lon":1847},{"facility":1851,"status":147,"city":1843,"state":11,"zip":1852,"country":1796,"countryCode":11,"cosmosGeoPoint":1853,"geoPoint":1855,"contacts":11},"Izmir Ataturk Training and Research Hospital","35360",{"type":140,"coordinates":1854},[1847,1848],{"lat":1848,"lon":1847},{"facility":1857,"status":184,"city":1858,"state":11,"zip":1859,"country":1796,"countryCode":11,"cosmosGeoPoint":1860,"geoPoint":1864,"contacts":11},"Goztepe Prof.Dr. Suleyman Yalcin City Hospital","Kadiköy","34722",{"type":140,"coordinates":1861},[1862,1863],41.01294,41.06639,{"lat":1863,"lon":1862},{"facility":1866,"status":133,"city":1867,"state":11,"zip":1868,"country":1796,"countryCode":11,"cosmosGeoPoint":1869,"geoPoint":1873,"contacts":11},"Medical Park Seyhan Hospital","Seyhan","01140",{"type":140,"coordinates":1870},[1871,1872],35.30592,36.98747,{"lat":1872,"lon":1871},{"facility":1875,"status":147,"city":1876,"state":11,"zip":1877,"country":1796,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Hacettepe Uni Medical Faculty Hospital","Sihhiye\u002FAnkara","06230",{"facility":1879,"status":133,"city":1880,"state":11,"zip":1881,"country":1882,"countryCode":1883,"cosmosGeoPoint":1884,"geoPoint":1888,"contacts":11},"Basingstoke and North Hampshire Hospital","Basingstoke","RG24 9NA","United Kingdom","UK",{"type":140,"coordinates":1885},[1886,1887],-1.08708,51.26249,{"lat":1887,"lon":1886},{"facility":1890,"status":147,"city":1891,"state":11,"zip":1892,"country":1882,"countryCode":1883,"cosmosGeoPoint":1893,"geoPoint":1897,"contacts":11},"Blackpool Victoria Hospital","Blackpool","FY3 8NR",{"type":140,"coordinates":1894},[1895,1896],-3.05,53.81667,{"lat":1896,"lon":1895},{"facility":1899,"status":133,"city":1900,"state":11,"zip":1901,"country":1882,"countryCode":1883,"cosmosGeoPoint":1902,"geoPoint":1906,"contacts":11},"Dumfries and Galloway Royal Infirmary","Dumfries","DG1 4AP",{"type":140,"coordinates":1903},[1904,1905],-3.61139,55.06959,{"lat":1905,"lon":1904},{"facility":1908,"status":147,"city":1909,"state":11,"zip":1910,"country":1882,"countryCode":1883,"cosmosGeoPoint":1911,"geoPoint":1915,"contacts":11},"Western General Hospital","Edinburgh","EH4 2XU",{"type":140,"coordinates":1912},[1913,1914],-3.19648,55.95206,{"lat":1914,"lon":1913},{"facility":1917,"status":147,"city":1918,"state":11,"zip":1919,"country":1882,"countryCode":1883,"cosmosGeoPoint":1920,"geoPoint":1924,"contacts":11},"Princess Alexandra Hospital","Harlow","CM20 1QX",{"type":140,"coordinates":1921},[1922,1923],0.11158,51.77655,{"lat":1923,"lon":1922},{"facility":1926,"status":133,"city":1927,"state":11,"zip":1928,"country":1882,"countryCode":1883,"cosmosGeoPoint":1929,"geoPoint":1933,"contacts":11},"St John's Hospital","Livingston","EH54 6PP",{"type":140,"coordinates":1930},[1931,1932],-3.52261,55.90288,{"lat":1932,"lon":1931},{"facility":1935,"status":184,"city":1936,"state":11,"zip":1937,"country":1882,"countryCode":1883,"cosmosGeoPoint":1938,"geoPoint":1942,"contacts":11},"St Bartholomew's Hospital","London","EC1M 6BQ",{"type":140,"coordinates":1939},[1940,1941],-0.12574,51.50853,{"lat":1941,"lon":1940},{"facility":1944,"status":184,"city":1945,"state":11,"zip":1946,"country":1882,"countryCode":1883,"cosmosGeoPoint":1947,"geoPoint":1951,"contacts":11},"Maidstone & Tonbridge Wells Hospital","Maidstone","ME16 9QQ",{"type":140,"coordinates":1948},[1949,1950],0.51667,51.26667,{"lat":1950,"lon":1949},{"facility":1953,"status":147,"city":1954,"state":11,"zip":1955,"country":1882,"countryCode":1883,"cosmosGeoPoint":1956,"geoPoint":1960,"contacts":11},"Mount Vernon & Watford Hospital Trust","Northwood","HA6 2RN",{"type":140,"coordinates":1957},[1958,1959],-0.42454,51.61162,{"lat":1959,"lon":1958},{"facility":1962,"status":147,"city":1963,"state":11,"zip":1964,"country":1882,"countryCode":1883,"cosmosGeoPoint":1965,"geoPoint":1969,"contacts":11},"Churchill Hospital","Oxford","OX3 7LE",{"type":140,"coordinates":1966},[1967,1968],-1.25596,51.75222,{"lat":1968,"lon":1967},{"facility":1971,"status":133,"city":1972,"state":11,"zip":1973,"country":1882,"countryCode":1883,"cosmosGeoPoint":1974,"geoPoint":1978,"contacts":11},"Royal Preston Hosptial","Preston","PR2 9HT",{"type":140,"coordinates":1975},[1976,1977],-2.70452,53.76282,{"lat":1977,"lon":1976},{"facility":1980,"status":133,"city":1981,"state":11,"zip":1982,"country":1882,"countryCode":1883,"cosmosGeoPoint":1983,"geoPoint":1987,"contacts":11},"Royal Hampshire County Hospital","Winchester","SO22 5DG",{"type":140,"coordinates":1984},[1985,1986],-1.3187,51.06513,{"lat":1986,"lon":1985},{"type":1989,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100488957","phase-3-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-cdk46i-and-endocrine-combination-therapy-100488957",false,"NCT05646862","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\u002F6i and Endocrine Combination Therapy","A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4\u002F6 Inhibitor and Endocrine Combination Therapy","INAVO121","Inclusion Criteria for Main Study and Sub-study:\n\n* If pre\u002Fperimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1\n* Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n* Documented HR +\u002F HER2- tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test\n* Disease progression after or during treatment with a combination of CDK4\u002F6i and endocrine therapy: \\\u003C= 2 prior lines of systemic therapy in mBC setting; CDK4\u002F6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed\n* Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n* Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Life expectancy of \\> 6 months\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria for both Main Study and Sub-study:\n\n* Metaplastic breast cancer\n* Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K\u002F-AKT\u002F-mTOR pathway\n* Participant who relapsed with documented evidence of progression \\> 12 months from completion of adjuvant CDK4\u002F6i based therapy with no treatment for metastatic disease\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Inability or unwillingness to swallow pills\n* Malabsorption syndrome or other condition that would interfere with enteral absorption\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Requirement for daily supplemental oxygen\n* Symptomatic active lung disease, including pneumonitis\n* History of or active inflammatory bowel disease\n* Any active bowel inflammation\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Participants with known human immunodeficiency virus infection that meet specific criteria\n* History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence\n* Chronic therapy of \\>= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease\n* Active ongoing osteonecrosis of the jaw\n\nExclusion Criteria for Main Study Only:\n\n* Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment\n* Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1\n* Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer\n* Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations\n* History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms\n\nExclusion Criteria for Sub-study Only:\n\n* Pregnant, lactating, or breastfeeding, or intending to become pregnant during the substudy or within 2 weeks after the final dose of inavolisib and within 2 years after the final dose of fulvestrant, whichever is longer\n* Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day -4 of Cycle 1\n* Investigational drug(s) within 4 weeks prior to Day -4 or within 5 half-lives of the investigational drug(s), whichever is longer\n* Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant formulations\n* Treatment with mild, moderate, or strong inducers of CYP2B6, CYP3A4, and\u002For CYP2C19 (including St. John's Wort) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1\n* Treatment with mild, moderate, or strong inhibitors of CYP2B6, CYP3A4, and\u002For CYP2C19 (including grapefruit juice or supplements) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1","ALL","18 Years",{"count":2001,"type":2002},420,"ESTIMATED","INTERVENTIONAL",[2005],"PHASE3","This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4\u002F6i (CDK4\u002F6i)-based therapy.\n\nEnrollment for the main study is now complete.",[2008],"Breast Cancer","2026-08-28",{"date":2011,"type":2012},"2026-09-01","ACTUAL",{"date":2014,"type":2012},"2023-06-07",{"date":2016,"type":2002},"2029-03-30",{"name":5,"class":6},210]