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No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[44,58,68,78,87,93,102,111,120,129,138,147,156,165,174,183,192,201,210,219,228,237,245],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":10},"Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)","RECRUITING","Lanzhou","Gansu","730050","China","CN",{"type":53,"coordinates":54},"Point",[55,56],103.83987,36.05701,{"lat":56,"lon":55},{"facility":59,"status":46,"city":60,"state":61,"zip":62,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":67,"contacts":10},"The First Hospital of Jilin University","Changchun","Jilin","130021",{"type":53,"coordinates":64},[65,66],125.32278,43.88,{"lat":66,"lon":65},{"facility":69,"status":46,"city":70,"state":71,"zip":72,"country":50,"countryCode":51,"cosmosGeoPoint":73,"geoPoint":77,"contacts":10},"Wenzhou 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province","Yangzhou","225001",{"type":53,"coordinates":250},[251,252],119.43583,32.39722,{"lat":252,"lon":251},{"type":255,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100619667","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-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":267,"type":268},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.",[272,273],"Locally Advanced Breast Cancer","Metastatic Breast Cancer","2026-06-11",{"date":276,"type":277},"2026-06-12","ACTUAL",{"date":279,"type":277},"2026-01-21",{"date":281,"type":268},"2029-09-09",{"name":5,"class":6},23]