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City","600566","Taiwan","TW",{"type":112,"coordinates":2037},[2038,2039],120.44889,23.47917,{"lat":2039,"lon":2038},{"facility":2042,"status":105,"city":2043,"state":11,"zip":2044,"country":2034,"countryCode":2035,"cosmosGeoPoint":2045,"geoPoint":2049,"contacts":11},"Taichung Veterans General Hospital","Taichung","407219",{"type":112,"coordinates":2046},[2047,2048],120.6839,24.1469,{"lat":2048,"lon":2047},{"facility":2051,"status":105,"city":2052,"state":11,"zip":2053,"country":2034,"countryCode":2035,"cosmosGeoPoint":2054,"geoPoint":2058,"contacts":11},"National Cheng Kung Uni Hospital","Tainan","704",{"type":112,"coordinates":2055},[2056,2057],120.21333,22.99083,{"lat":2057,"lon":2056},{"facility":2060,"status":105,"city":2061,"state":11,"zip":2062,"country":2034,"countryCode":2035,"cosmosGeoPoint":2063,"geoPoint":2067,"contacts":11},"National Taiwan Uni 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(Türkiye)",{"type":112,"coordinates":2086},[2087,2088],32.85427,39.91987,{"lat":2088,"lon":2087},{"facility":2091,"status":105,"city":2082,"state":11,"zip":2092,"country":2084,"countryCode":11,"cosmosGeoPoint":2093,"geoPoint":2095,"contacts":11},"Ankara City Hospital","06800",{"type":112,"coordinates":2094},[2087,2088],{"lat":2088,"lon":2087},{"facility":2097,"status":105,"city":2098,"state":11,"zip":2099,"country":2084,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji","Bakirkoy \u002F Istanbul","34147",{"facility":2101,"status":105,"city":2102,"state":11,"zip":2103,"country":2084,"countryCode":11,"cosmosGeoPoint":2104,"geoPoint":2108,"contacts":11},"Ba?c?lar Medipol Mega Üniversite Hastanesi","Istanbul","34214",{"type":112,"coordinates":2105},[2106,2107],28.94966,41.01384,{"lat":2107,"lon":2106},{"facility":2110,"status":105,"city":2111,"state":11,"zip":2112,"country":2084,"countryCode":11,"cosmosGeoPoint":2113,"geoPoint":2117,"contacts":11},"Izmir Ataturk Training and Research Hospital","Izmir","35360",{"type":112,"coordinates":2114},[2115,2116],27.13838,38.41273,{"lat":2116,"lon":2115},{"facility":2119,"status":105,"city":2120,"state":11,"zip":2121,"country":2084,"countryCode":11,"cosmosGeoPoint":2122,"geoPoint":2126,"contacts":11},"Mersin City Education and Research Hospital","Mersin","33240",{"type":112,"coordinates":2123},[2124,2125],34.63886,36.81196,{"lat":2125,"lon":2124},{"facility":2128,"status":105,"city":2129,"state":11,"zip":2130,"country":2131,"countryCode":2132,"cosmosGeoPoint":2133,"geoPoint":2137,"contacts":11},"Blackpool Victoria Hospital","Blackpool","FY3 8NR","United Kingdom","UK",{"type":112,"coordinates":2134},[2135,2136],-3.05,53.81667,{"lat":2136,"lon":2135},{"facility":2139,"status":105,"city":2140,"state":11,"zip":2141,"country":2131,"countryCode":2132,"cosmosGeoPoint":2142,"geoPoint":2146,"contacts":11},"Colchester General Hospital","Colchester, Essex","CO4 5JL",{"type":112,"coordinates":2143},[2144,2145],0.90421,51.88921,{"lat":2145,"lon":2144},{"facility":2148,"status":105,"city":2149,"state":11,"zip":2150,"country":2131,"countryCode":2132,"cosmosGeoPoint":2151,"geoPoint":2155,"contacts":11},"Western General Hospital","Edinburgh","EH4 2XU",{"type":112,"coordinates":2152},[2153,2154],-3.19648,55.95206,{"lat":2154,"lon":2153},{"facility":2157,"status":105,"city":2158,"state":11,"zip":2159,"country":2131,"countryCode":2132,"cosmosGeoPoint":2160,"geoPoint":2164,"contacts":11},"Princess Alexandra Hospital","Harlow","CM20 1QX",{"type":112,"coordinates":2161},[2162,2163],0.11158,51.77655,{"lat":2163,"lon":2162},{"facility":2166,"status":105,"city":2167,"state":11,"zip":2168,"country":2131,"countryCode":2132,"cosmosGeoPoint":2169,"geoPoint":2173,"contacts":11},"St Bartholomew's Hospital","London","EC1M 6BQ",{"type":112,"coordinates":2170},[2171,2172],-0.12574,51.50853,{"lat":2172,"lon":2171},{"facility":2175,"status":105,"city":2167,"state":11,"zip":2176,"country":2131,"countryCode":2132,"cosmosGeoPoint":2177,"geoPoint":2179,"contacts":11},"Royal Free Hospital","NW3 2QG",{"type":112,"coordinates":2178},[2171,2172],{"lat":2172,"lon":2171},{"facility":2181,"status":105,"city":2182,"state":11,"zip":2183,"country":2131,"countryCode":2132,"cosmosGeoPoint":2184,"geoPoint":2188,"contacts":11},"Mount Vernon & Watford Hospital Trust","Northwood","HA6 2RN",{"type":112,"coordinates":2185},[2186,2187],-0.42454,51.61162,{"lat":2187,"lon":2186},{"facility":2190,"status":105,"city":2191,"state":11,"zip":2192,"country":2131,"countryCode":2132,"cosmosGeoPoint":2193,"geoPoint":2197,"contacts":11},"Churchill Hospital - Oxford Cancer & Haematology Centre","Oxford","OX3 7LE",{"type":112,"coordinates":2194},[2195,2196],-1.25596,51.75222,{"lat":2196,"lon":2195},{"facility":2199,"status":105,"city":2200,"state":11,"zip":2201,"country":2131,"countryCode":2132,"cosmosGeoPoint":2202,"geoPoint":2206,"contacts":11},"Weston Park Hospital","Sheffield","S10 2SJ",{"type":112,"coordinates":2203},[2204,2205],-1.4659,53.38297,{"lat":2205,"lon":2204},{"type":2208,"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":2220,"type":2221},450,"ESTIMATED","INTERVENTIONAL",[2224],"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).",[2227],"Breast Cancer","2026-10-05",{"date":2230,"type":2231},"2026-10-06","ACTUAL",{"date":2233,"type":2231},"2025-04-09",{"date":2235,"type":2221},"2032-02-01",{"name":5,"class":6},242]