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Mai","50180",{"type":66,"coordinates":1892},[1893,1894],98.98468,18.79038,{"lat":1894,"lon":1893},{"facility":59,"status":60,"city":1897,"state":35,"zip":1898,"country":1872,"cosmosGeoPoint":1899,"geoPoint":1903,"contacts":35},"Samut Sakhon","74120",{"type":66,"coordinates":1900},[1901,1902],100.27362,13.54753,{"lat":1902,"lon":1901},{"facility":59,"status":60,"city":1905,"state":35,"zip":1906,"country":1872,"cosmosGeoPoint":1907,"geoPoint":1911,"contacts":35},"Songkhla","90110",{"type":66,"coordinates":1908},[1909,1910],100.5951,7.19882,{"lat":1910,"lon":1909},{"facility":59,"status":60,"city":1913,"state":1914,"zip":1915,"country":1916,"cosmosGeoPoint":1917,"geoPoint":1921,"contacts":35},"Leicester","Leicestershire","LE1 5WW","United Kingdom",{"type":66,"coordinates":1918},[1919,1920],-1.13169,52.6386,{"lat":1920,"lon":1919},{"facility":59,"status":60,"city":1923,"state":1923,"zip":1924,"country":1916,"cosmosGeoPoint":1925,"geoPoint":1929,"contacts":35},"Nottingham","NG5 1PB",{"type":66,"coordinates":1926},[1927,1928],-1.15047,52.9536,{"lat":1928,"lon":1927},{"facility":59,"status":60,"city":1931,"state":1932,"zip":1933,"country":1916,"cosmosGeoPoint":1934,"geoPoint":1938,"contacts":35},"Taunton","Somerset","TA1 5DA",{"type":66,"coordinates":1935},[1936,1937],-3.10293,51.01494,{"lat":1937,"lon":1936},{"facility":59,"status":60,"city":1940,"state":35,"zip":1941,"country":1916,"cosmosGeoPoint":1942,"geoPoint":1946,"contacts":35},"Bodelwyddan","LL18 5UJ",{"type":66,"coordinates":1943},[1944,1945],-3.50078,53.26827,{"lat":1945,"lon":1944},{"facility":59,"status":60,"city":815,"state":35,"zip":1948,"country":1916,"cosmosGeoPoint":1949,"geoPoint":1953,"contacts":35},"EC1A 7BE",{"type":66,"coordinates":1950},[1951,1952],-0.12574,51.50853,{"lat":1952,"lon":1951},{"type":1955,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100517376",false,"NCT06016738","OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4\u002F6 Inhibitor Therapy (OPERA-01)","OPERA-01","Key inclusion criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease or bone-only disease).\n* Previously received a CDK4\u002F6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nKey exclusion criteria:\n\n* Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.\n* Previously received chemotherapy in the advanced\u002Fmetastatic setting.\n* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.\n* History of allergic reactions to study treatment.\n* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.\n* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.","ALL","18 Years",{"count":1966,"type":1967},510,"ESTIMATED","INTERVENTIONAL",[1970],"PHASE3","This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4\u002F6 inhibitor.",[1973,1974,1975,1976,1977],"Breast Cancer","Advanced Breast Cancer","Metastatic Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma","2026-03-11",{"date":1980,"type":1981},"2026-03-13","ACTUAL",{"date":1983,"type":1981},"2023-11-16",{"date":1985,"type":1967},"2027-09-30",{"name":5,"class":6},233]