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Hospital","Taipei","100",{"type":66,"coordinates":1929},[1930,1931],121.52639,25.05306,{"lat":1931,"lon":1930},{"facility":1934,"status":59,"city":1926,"state":35,"zip":1935,"country":1899,"countryCode":1900,"cosmosGeoPoint":1936,"geoPoint":1938,"contacts":35},"Koo Foundation Sun Yat-Sen Cancer Center","112019",{"type":66,"coordinates":1937},[1930,1931],{"lat":1931,"lon":1930},{"facility":1940,"status":59,"city":1926,"state":35,"zip":1941,"country":1899,"countryCode":1900,"cosmosGeoPoint":1942,"geoPoint":1944,"contacts":35},"Taipei Veterans General Hospital","112201",{"type":66,"coordinates":1943},[1930,1931],{"lat":1931,"lon":1930},{"facility":1946,"status":59,"city":1947,"state":35,"zip":1948,"country":1949,"countryCode":35,"cosmosGeoPoint":1950,"geoPoint":1954,"contacts":35},"Abdurrahman Yurtarslan Onkoloji Training and Research Hospital","Ankara","06200","Turkey (Türkiye)",{"type":66,"coordinates":1951},[1952,1953],32.85427,39.91987,{"lat":1953,"lon":1952},{"facility":1956,"status":59,"city":1947,"state":35,"zip":1957,"country":1949,"countryCode":35,"cosmosGeoPoint":1958,"geoPoint":1960,"contacts":35},"Ankara City Hospital","06800",{"type":66,"coordinates":1959},[1952,1953],{"lat":1953,"lon":1952},{"facility":1962,"status":59,"city":1963,"state":35,"zip":1964,"country":1949,"countryCode":35,"cosmosGeoPoint":35,"geoPoint":35,"contacts":35},"Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji","Bakirkoy \u002F Istanbul","34147",{"facility":1966,"status":59,"city":1967,"state":35,"zip":1968,"country":1949,"countryCode":35,"cosmosGeoPoint":1969,"geoPoint":1973,"contacts":35},"Ba?c?lar Medipol Mega Üniversite Hastanesi","Istanbul","34214",{"type":66,"coordinates":1970},[1971,1972],28.94966,41.01384,{"lat":1972,"lon":1971},{"facility":1975,"status":59,"city":1976,"state":35,"zip":1977,"country":1949,"countryCode":35,"cosmosGeoPoint":1978,"geoPoint":1982,"contacts":35},"Izmir Ataturk Training and Research Hospital","Izmir","35360",{"type":66,"coordinates":1979},[1980,1981],27.13838,38.41273,{"lat":1981,"lon":1980},{"facility":1984,"status":59,"city":1985,"state":35,"zip":1986,"country":1949,"countryCode":35,"cosmosGeoPoint":1987,"geoPoint":1991,"contacts":35},"Mersin City Education and Research Hospital","Mersin","33240",{"type":66,"coordinates":1988},[1989,1990],34.63886,36.81196,{"lat":1990,"lon":1989},{"facility":1993,"status":59,"city":1994,"state":35,"zip":1995,"country":1996,"countryCode":1997,"cosmosGeoPoint":1998,"geoPoint":2002,"contacts":35},"Blackpool Victoria Hospital","Blackpool","FY3 8NR","United Kingdom","UK",{"type":66,"coordinates":1999},[2000,2001],-3.05,53.81667,{"lat":2001,"lon":2000},{"facility":2004,"status":59,"city":2005,"state":35,"zip":2006,"country":1996,"countryCode":1997,"cosmosGeoPoint":2007,"geoPoint":2011,"contacts":35},"Colchester General Hospital","Colchester, Essex","CO4 5JL",{"type":66,"coordinates":2008},[2009,2010],0.90421,51.88921,{"lat":2010,"lon":2009},{"facility":2013,"status":59,"city":2014,"state":35,"zip":2015,"country":1996,"countryCode":1997,"cosmosGeoPoint":2016,"geoPoint":2020,"contacts":35},"Western General Hospital","Edinburgh","EH4 2XU",{"type":66,"coordinates":2017},[2018,2019],-3.19648,55.95206,{"lat":2019,"lon":2018},{"facility":2022,"status":59,"city":2023,"state":35,"zip":2024,"country":1996,"countryCode":1997,"cosmosGeoPoint":2025,"geoPoint":2029,"contacts":35},"Princess Alexandra Hospital","Harlow","CM20 1QX",{"type":66,"coordinates":2026},[2027,2028],0.11158,51.77655,{"lat":2028,"lon":2027},{"facility":2031,"status":59,"city":2032,"state":35,"zip":2033,"country":1996,"countryCode":1997,"cosmosGeoPoint":2034,"geoPoint":2038,"contacts":35},"St Bartholomew's Hospital","London","EC1M 6BQ",{"type":66,"coordinates":2035},[2036,2037],-0.12574,51.50853,{"lat":2037,"lon":2036},{"facility":2040,"status":59,"city":2032,"state":35,"zip":2041,"country":1996,"countryCode":1997,"cosmosGeoPoint":2042,"geoPoint":2044,"contacts":35},"Royal Free Hospital","NW3 2QG",{"type":66,"coordinates":2043},[2036,2037],{"lat":2037,"lon":2036},{"facility":2046,"status":59,"city":2047,"state":35,"zip":2048,"country":1996,"countryCode":1997,"cosmosGeoPoint":2049,"geoPoint":2053,"contacts":35},"Mount Vernon & Watford Hospital Trust","Northwood","HA6 2RN",{"type":66,"coordinates":2050},[2051,2052],-0.42454,51.61162,{"lat":2052,"lon":2051},{"facility":2055,"status":59,"city":2056,"state":35,"zip":2057,"country":1996,"countryCode":1997,"cosmosGeoPoint":2058,"geoPoint":2062,"contacts":35},"Churchill Hospital - Oxford Cancer & Haematology Centre","Oxford","OX3 7LE",{"type":66,"coordinates":2059},[2060,2061],-1.25596,51.75222,{"lat":2061,"lon":2060},{"facility":2064,"status":59,"city":2065,"state":35,"zip":2066,"country":1996,"countryCode":1997,"cosmosGeoPoint":2067,"geoPoint":2071,"contacts":35},"Weston Park Hospital","Sheffield","S10 2SJ",{"type":66,"coordinates":2068},[2069,2070],-1.4659,53.38297,{"lat":2070,"lon":2069},{"type":2073,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"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":2085,"type":2086},450,"ESTIMATED","INTERVENTIONAL",[2089],"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).",[2092],"Breast Cancer","2026-07-01",{"date":2095,"type":2096},"2026-07-02","ACTUAL",{"date":2098,"type":2096},"2025-04-09",{"date":2100,"type":2086},"2032-05-30",{"name":5,"class":6},232]