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7XX",{"type":64,"coordinates":1307},[1308,1309],-0.57427,51.23536,{"lat":1309,"lon":1308},{"type":1312,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[1314],{"name":1315,"class":6},"Novartis Pharmaceuticals","100599536",false,"NCT07085767","Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","OPERA-02","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 per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)\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\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.","ALL","18 Years",{"count":1326,"type":1327},1000,"ESTIMATED","INTERVENTIONAL",[1330],"PHASE3","This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.",[1333,1334,1335,1336,1337],"Breast Cancer","Locally Advanced Breast Cancer","Metastatic Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[1339,1340,1341,1342,1343,9,1344,1345,36,1346,17,1347,1348],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","CDK4\u002F6i","Aromatase inhibitors","Antineoplastic agents","2026-06-12",{"date":1351,"type":1352},"2026-06-16","ACTUAL",{"date":1354,"type":1352},"2025-11-03",{"date":1356,"type":1327},"2032-01",{"name":5,"class":6},150]