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(Türkiye)",{"type":65,"coordinates":1934},[1935,1936],32.85427,39.91987,{"lat":1936,"lon":1935},{"facility":1939,"status":59,"city":1930,"state":35,"zip":1940,"country":1932,"cosmosGeoPoint":1941,"geoPoint":1943,"contacts":35},"Ankara City Hospital","06800",{"type":65,"coordinates":1942},[1935,1936],{"lat":1936,"lon":1935},{"facility":1945,"status":59,"city":1946,"state":35,"zip":1947,"country":1932,"cosmosGeoPoint":35,"geoPoint":35,"contacts":35},"Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji","Bakirkoy \u002F Istanbul","34147",{"facility":1949,"status":59,"city":1950,"state":35,"zip":1951,"country":1932,"cosmosGeoPoint":1952,"geoPoint":1956,"contacts":35},"Ba?c?lar Medipol Mega Üniversite Hastanesi","Istanbul","34214",{"type":65,"coordinates":1953},[1954,1955],28.94966,41.01384,{"lat":1955,"lon":1954},{"facility":1958,"status":59,"city":1959,"state":35,"zip":1960,"country":1932,"cosmosGeoPoint":1961,"geoPoint":1965,"contacts":35},"Izmir Ataturk Training and 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7LE",{"type":65,"coordinates":2041},[2042,2043],-1.25596,51.75222,{"lat":2043,"lon":2042},{"facility":2046,"status":59,"city":2047,"state":35,"zip":2048,"country":1979,"cosmosGeoPoint":2049,"geoPoint":2053,"contacts":35},"Weston Park Hospital","Sheffield","S10 2SJ",{"type":65,"coordinates":2050},[2051,2052],-1.4659,53.38297,{"lat":2052,"lon":2051},{"type":2055,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":2066,"type":2067},450,"ESTIMATED","INTERVENTIONAL",[2070],"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).",[2073],"Breast Cancer","2026-07-01",{"date":2076,"type":2077},"2026-07-02","ACTUAL",{"date":2079,"type":2077},"2025-04-09",{"date":2081,"type":2067},"2032-05-30",{"name":5,"class":6},232]