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Hospital","Taipei","100",{"type":112,"coordinates":1975},[1976,1977],121.52639,25.05306,{"lat":1977,"lon":1976},{"facility":1980,"status":105,"city":1972,"state":11,"zip":1981,"country":1945,"countryCode":1946,"cosmosGeoPoint":1982,"geoPoint":1984,"contacts":11},"Koo Foundation Sun Yat-Sen Cancer Center","112019",{"type":112,"coordinates":1983},[1976,1977],{"lat":1977,"lon":1976},{"facility":1986,"status":105,"city":1972,"state":11,"zip":1987,"country":1945,"countryCode":1946,"cosmosGeoPoint":1988,"geoPoint":1990,"contacts":11},"Taipei Veterans General Hospital","112201",{"type":112,"coordinates":1989},[1976,1977],{"lat":1977,"lon":1976},{"facility":1992,"status":105,"city":1993,"state":11,"zip":1994,"country":1995,"countryCode":11,"cosmosGeoPoint":1996,"geoPoint":2000,"contacts":11},"Abdurrahman Yurtarslan Onkoloji Training and Research Hospital","Ankara","06200","Turkey (Türkiye)",{"type":112,"coordinates":1997},[1998,1999],32.85427,39.91987,{"lat":1999,"lon":1998},{"facility":2002,"status":105,"city":1993,"state":11,"zip":2003,"country":1995,"countryCode":11,"cosmosGeoPoint":2004,"geoPoint":2006,"contacts":11},"Ankara City Hospital","06800",{"type":112,"coordinates":2005},[1998,1999],{"lat":1999,"lon":1998},{"facility":2008,"status":105,"city":2009,"state":11,"zip":2010,"country":1995,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji","Bakirkoy \u002F Istanbul","34147",{"facility":2012,"status":105,"city":2013,"state":11,"zip":2014,"country":1995,"countryCode":11,"cosmosGeoPoint":2015,"geoPoint":2019,"contacts":11},"Ba?c?lar Medipol Mega Üniversite Hastanesi","Istanbul","34214",{"type":112,"coordinates":2016},[2017,2018],28.94966,41.01384,{"lat":2018,"lon":2017},{"facility":2021,"status":105,"city":2022,"state":11,"zip":2023,"country":1995,"countryCode":11,"cosmosGeoPoint":2024,"geoPoint":2028,"contacts":11},"Izmir Ataturk Training and Research Hospital","Izmir","35360",{"type":112,"coordinates":2025},[2026,2027],27.13838,38.41273,{"lat":2027,"lon":2026},{"facility":2030,"status":105,"city":2031,"state":11,"zip":2032,"country":1995,"countryCode":11,"cosmosGeoPoint":2033,"geoPoint":2037,"contacts":11},"Mersin City Education and Research Hospital","Mersin","33240",{"type":112,"coordinates":2034},[2035,2036],34.63886,36.81196,{"lat":2036,"lon":2035},{"facility":2039,"status":105,"city":2040,"state":11,"zip":2041,"country":2042,"countryCode":2043,"cosmosGeoPoint":2044,"geoPoint":2048,"contacts":11},"Blackpool Victoria Hospital","Blackpool","FY3 8NR","United Kingdom","UK",{"type":112,"coordinates":2045},[2046,2047],-3.05,53.81667,{"lat":2047,"lon":2046},{"facility":2050,"status":105,"city":2051,"state":11,"zip":2052,"country":2042,"countryCode":2043,"cosmosGeoPoint":2053,"geoPoint":2057,"contacts":11},"Colchester General Hospital","Colchester, Essex","CO4 5JL",{"type":112,"coordinates":2054},[2055,2056],0.90421,51.88921,{"lat":2056,"lon":2055},{"facility":2059,"status":105,"city":2060,"state":11,"zip":2061,"country":2042,"countryCode":2043,"cosmosGeoPoint":2062,"geoPoint":2066,"contacts":11},"Western General Hospital","Edinburgh","EH4 2XU",{"type":112,"coordinates":2063},[2064,2065],-3.19648,55.95206,{"lat":2065,"lon":2064},{"facility":2068,"status":105,"city":2069,"state":11,"zip":2070,"country":2042,"countryCode":2043,"cosmosGeoPoint":2071,"geoPoint":2075,"contacts":11},"Princess Alexandra Hospital","Harlow","CM20 1QX",{"type":112,"coordinates":2072},[2073,2074],0.11158,51.77655,{"lat":2074,"lon":2073},{"facility":2077,"status":105,"city":2078,"state":11,"zip":2079,"country":2042,"countryCode":2043,"cosmosGeoPoint":2080,"geoPoint":2084,"contacts":11},"St Bartholomew's Hospital","London","EC1M 6BQ",{"type":112,"coordinates":2081},[2082,2083],-0.12574,51.50853,{"lat":2083,"lon":2082},{"facility":2086,"status":105,"city":2078,"state":11,"zip":2087,"country":2042,"countryCode":2043,"cosmosGeoPoint":2088,"geoPoint":2090,"contacts":11},"Royal Free Hospital","NW3 2QG",{"type":112,"coordinates":2089},[2082,2083],{"lat":2083,"lon":2082},{"facility":2092,"status":105,"city":2093,"state":11,"zip":2094,"country":2042,"countryCode":2043,"cosmosGeoPoint":2095,"geoPoint":2099,"contacts":11},"Mount Vernon & Watford Hospital Trust","Northwood","HA6 2RN",{"type":112,"coordinates":2096},[2097,2098],-0.42454,51.61162,{"lat":2098,"lon":2097},{"facility":2101,"status":105,"city":2102,"state":11,"zip":2103,"country":2042,"countryCode":2043,"cosmosGeoPoint":2104,"geoPoint":2108,"contacts":11},"Churchill Hospital - Oxford Cancer & Haematology Centre","Oxford","OX3 7LE",{"type":112,"coordinates":2105},[2106,2107],-1.25596,51.75222,{"lat":2107,"lon":2106},{"facility":2110,"status":105,"city":2111,"state":11,"zip":2112,"country":2042,"countryCode":2043,"cosmosGeoPoint":2113,"geoPoint":2117,"contacts":11},"Weston Park Hospital","Sheffield","S10 2SJ",{"type":112,"coordinates":2114},[2115,2116],-1.4659,53.38297,{"lat":2116,"lon":2115},{"type":2119,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100576853","phase-3-a-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-cdk46-inhibitor-and-letrozole-vs-placebo--cdk46i-and-letrozole-in-participants-with-endocrine-sensitive-pik3ca-mutated-hormone-receptor-positive-her2-negative-advanced-breast-cancer-100576853",false,"NCT06790693","A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4\u002F6 Inhibitor and Letrozole vs Placebo + CDK4\u002F6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4\u002F6 Inhibitor and Letrozole Versus Placebo Plus a CDK4\u002F6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","INAVO123","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast\n* Documented ER-positive and\u002For progesterone receptor-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Documented HER2-negative tumor according to ASCO\u002FCAP guidelines\n* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant\u002Fadjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment\n* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative\n* Confirmation of biomarker eligibility\n* Consent to provide fresh or archival tumor tissue specimen\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Metaplastic breast cancer\n* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of or active inflammatory bowel disease\n* Any active bowel inflammation\n* Prior hematopoietic stem cell or bone marrow transplantation\n* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment","ALL","18 Years",{"count":2131,"type":2132},450,"ESTIMATED","INTERVENTIONAL",[2135],"PHASE3","This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4\u002F6i) and letrozole versus placebo plus a CDK4\u002F6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).",[2138],"Breast Cancer","2026-07-01",{"date":2141,"type":2142},"2026-07-02","ACTUAL",{"date":2144,"type":2142},"2025-04-09",{"date":2146,"type":2132},"2032-05-30",{"name":5,"class":6},232]