[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619667":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":253,"collaborators":10,"id":255,"slug":10,"hasResults":256,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":256,"sex":262,"minAge":263,"maxAge":10,"enrollmentInfo":264,"targetDuration":10,"studyType":267,"phases":10,"briefSummary":268,"conditions":269,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Inavolisib",null,"Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA\u002FmBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.",[13,14,15],"Drug: Inavolisib","Drug: Palbociclib","Drug: Fulvestrant",[17,23,27],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.",[9],[22],"GDC-0077",{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Palbociclib","Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Fulvestrant","Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.",[9],[32],{"name":33,"affiliation":5,"role":34},"Clinical Trials","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Reference Study ID Number: ML46361 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":42,"role":38,"phone":10,"phoneExt":10,"email":10},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[44,57,67,77,86,92,101,110,119,128,137,146,155,164,173,182,191,200,209,218,227,236,244],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":10},"Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)","RECRUITING","Lanzhou","Gansu","730050","China",{"type":52,"coordinates":53},"Point",[54,55],103.83987,36.05701,{"lat":55,"lon":54},{"facility":58,"status":46,"city":59,"state":60,"zip":61,"country":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":10},"The First Hospital of Jilin University","Changchun","Jilin","130021",{"type":52,"coordinates":63},[64,65],125.32278,43.88,{"lat":65,"lon":64},{"facility":68,"status":46,"city":69,"state":70,"zip":71,"country":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":10},"Wenzhou Medical University Affiliated Second 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University Shanghai Cancer Center","Shanghai","200032",{"type":52,"coordinates":187},[188,189],121.45806,31.22222,{"lat":189,"lon":188},{"facility":192,"status":46,"city":193,"state":10,"zip":194,"country":50,"cosmosGeoPoint":195,"geoPoint":199,"contacts":10},"Liaoning cancer Hospital & Institute","Shenyang","110042",{"type":52,"coordinates":196},[197,198],123.43278,41.79222,{"lat":198,"lon":197},{"facility":201,"status":46,"city":202,"state":10,"zip":203,"country":50,"cosmosGeoPoint":204,"geoPoint":208,"contacts":10},"Shanxi Provincial Cancer Hospital","Taiyuan","030013",{"type":52,"coordinates":205},[206,207],112.56028,37.86944,{"lat":207,"lon":206},{"facility":210,"status":46,"city":211,"state":10,"zip":212,"country":50,"cosmosGeoPoint":213,"geoPoint":217,"contacts":10},"Taizhou Hospital of Zhejiang 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University","Xi'an",{"type":52,"coordinates":240},[241,242],108.92861,34.25833,{"lat":242,"lon":241},{"facility":245,"status":46,"city":246,"state":10,"zip":247,"country":50,"cosmosGeoPoint":248,"geoPoint":252,"contacts":10},"Subei People's Hospital of Jiangsu province","Yangzhou","225001",{"type":52,"coordinates":249},[250,251],119.43583,32.39722,{"lat":251,"lon":250},{"type":254,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100619667",false,"NCT07347600","A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)","reaINAVO","Inclusion Criteria:\n\n* Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+\u002FHER2- LA\u002FmBC, following recurrence on or after completing adjuvant endocrine therapy\n* Participants must receive the treatment of inavolisib for the first time\n* PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \\[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\\] by testing of blood or tumor tissue prior to the initiation of inavolisib\n\nExclusion Criteria:\n\n* Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant\n* Participants not receiving treatment for LA\u002FmBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)\u002Flocal labeling\n* At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study","ALL","18 Years",{"count":265,"type":266},500,"ESTIMATED","OBSERVATIONAL","The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA\u002FmBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.",[270,271],"Locally Advanced Breast Cancer","Metastatic Breast Cancer","2026-06-11",{"date":274,"type":275},"2026-06-12","ACTUAL",{"date":277,"type":275},"2026-01-21",{"date":279,"type":266},"2029-09-09",{"name":5,"class":6},23]