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Hospital","Zhengzhou","450008",{"type":53,"coordinates":295},[296,297],113.64861,34.75778,{"lat":297,"lon":296},{"type":300,"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":312,"type":313},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.",[317,318],"Locally Advanced Breast Cancer","Metastatic Breast Cancer","2026-08-07",{"date":321,"type":322},"2026-08-11","ACTUAL",{"date":324,"type":322},"2026-01-21",{"date":326,"type":313},"2029-09-09",{"name":5,"class":6},29]