[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07085767":3,"trial-entities:NCT07085767":1303,"trial-summary:NCT07085767":1307},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":38,"primary_purpose":39,"phases":40,"enrollment_info":42,"interventions":45,"primary_outcomes":66,"secondary_outcomes":71,"sex":108,"minimum_age":109,"maximum_age":110,"healthy_volunteers":111,"eligibility_criteria":112,"std_ages":130,"locations":133,"central_contacts":1289,"overall_officials":1294,"references":1298,"see_also_links":1299},"NCT07085767","OP-1250-302","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)","RECRUITING","2032-01","2026-08","2026-08-17","2025-11-03","Olema Pharmaceuticals, Inc.","INDUSTRY",true,"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.","This is an international, multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the efficacy and safety of palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A: investigational arm) with letrozole in combination with ribociclib + palazestrant-matching placebo (Arm B: control arm).\n\nThis trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.",[19,20,21,22,23],"Breast Cancer","Locally Advanced Breast Cancer","Metastatic Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[25,26,27,28,29,30,31,32,33,34,35,36,37],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Palazestrant","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","Ribociclib","CDK4\u002F6i","Letrozole","Aromatase inhibitors","Antineoplastic agents","INTERVENTIONAL","TREATMENT",[41],"PHASE3",{"count":43,"type":44},1000,"ESTIMATED",[46,52,56,59,62],{"type":47,"name":30,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.",[30],[51],"OP-1250",{"type":47,"name":53,"description":54,"armGroupLabels":55},"Letrozole-matching placebo","Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle",[30],{"type":47,"name":33,"description":57,"armGroupLabels":58},"Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.",[35,30],{"type":47,"name":35,"description":60,"armGroupLabels":61},"Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle",[35],{"type":47,"name":63,"description":64,"armGroupLabels":65},"Palazestrant matching-placebo","Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle",[35],[67],{"measure":68,"description":69,"timeFrame":70},"Progression-Free Survival (PFS)","To compare PFS, based on a local investigator assessment, between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.","From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)",[72,76,79,83,87,91,93,95,97,101,105],{"measure":73,"description":74,"timeFrame":75},"Overall Survival (OS)","To compare OS between investigational and control arms.","From Date of Randomization until Death Due to Any Cause (estimated as up to 5.5 years)",{"measure":77,"description":78,"timeFrame":70},"Progression Free Survival (PFS)","To evaluate PFS based on Blinded Independent Review Committee (BIRC) assessment",{"measure":80,"description":81,"timeFrame":82},"Overall response Rate (ORR)","To evaluate ORR based on Blinded Independent Review Committee (BIRC) assessment","From Date of Randomization until Tumor Response (estimated as up to 3.5 years)",{"measure":84,"description":85,"timeFrame":86},"Duration of Response (DOR)","To evaluate DOR based on Blinded Independent Review Committee (BIRC) assessment","From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)",{"measure":88,"description":89,"timeFrame":90},"Clinical Benefit Rate (CBR)","To evaluate CBR based on Blinded Independent Review Committee (BIRC) assessment","Proportion of subjects achieving CR, PR or SD with duration of at least 24 weeks (estimated as up to 3.5 years)",{"measure":80,"description":92,"timeFrame":82},"To evaluate ORR based on local investigator assessment",{"measure":84,"description":94,"timeFrame":86},"To evaluate DOR based on local investigator assessment",{"measure":88,"description":96,"timeFrame":90},"To evaluate CBR based on local investigator assessment",{"measure":98,"description":99,"timeFrame":100},"Safety and tolerability","To evaluate safety and tolerability assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status and vital sign measurements","Up to 42 days after end of treatment (estimated as up to 3.5 years)",{"measure":102,"description":103,"timeFrame":104},"Pharmacokinetics (PK) of palazestrant and ribociclib","To evaluate plasma levels of palazestrant and ribociclib to establish pharmacokinetic (PK) parameters","Every 28 days (estimated as up to 3.5 years)",{"measure":106,"description":107,"timeFrame":104},"Health-related patient-reported outcomes (PROs)","To evaluate the change from baseline in health-related PROs assessed using standardized instruments that are widely used in (breast) cancer clinical trials","ALL","18 Years",null,false,{"inclusion":113,"exclusion":122,"raw_text":129},[114,115,116,117,118,119,120,121],"Adult female or male participants.","ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.","Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).","De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.","Adequate hematologic, hepatic, and renal functions.","Female participants can be pre-, peri- or postmenopausal.","Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.",[123,124,125,126,127,128],"Disease recurrence during adjuvant endocrine therapy","Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.","Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.","History of allergic reactions to study treatment.","Any contraindications to letrozole and ribociclib.","Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.","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.",[131,132],"ADULT","OLDER_ADULT",[134,144,151,157,163,169,175,181,188,194,201,208,215,222,229,235,242,249,256,262,269,276,283,290,297,303,310,317,323,330,337,343,350,356,362,368,374,381,387,393,399,406,413,419,425,432,438,445,453,459,466,473,480,486,492,499,507,514,521,527,535,541,548,555,562,570,578,585,592,598,604,612,619,625,632,639,646,653,659,666,674,681,687,694,702,709,713,719,725,728,731,739,746,753,760,768,774,781,789,796,803,810,817,824,830,836,842,849,855,859,867,873,875,882,889,896,903,910,918,925,932,940,947,954,961,964,971,978,985,993,1000,1003,1010,1017,1024,1031,1038,1045,1053,1060,1067,1073,1079,1085,1091,1095,1098,1101,1105,1108,1115,1121,1124,1127,1133,1139,1145,1151,1154,1157,1160,1166,1173,1179,1185,1193,1200,1207,1210,1214,1217,1224,1230,1237,1244,1250,1258,1264,1268,1275,1282],{"facility":135,"status":136,"city":137,"state":138,"zip":139,"country":140,"geoPoint":141},"Clinical Trial Site","ACTIVE_NOT_RECRUITING","Hot Springs","Arkansas","71913","United States",{"lat":142,"lon":143},34.5037,-93.05518,{"facility":135,"status":8,"city":145,"state":146,"zip":147,"country":140,"geoPoint":148},"Beverly Hills","California","90211",{"lat":149,"lon":150},34.07362,-118.40036,{"facility":135,"status":8,"city":152,"state":146,"zip":153,"country":140,"geoPoint":154},"La Jolla","92093",{"lat":155,"lon":156},32.84727,-117.2742,{"facility":135,"status":8,"city":158,"state":146,"zip":159,"country":140,"geoPoint":160},"Los Alamitos","90720",{"lat":161,"lon":162},33.80307,-118.07256,{"facility":135,"status":8,"city":164,"state":146,"zip":165,"country":140,"geoPoint":166},"San Francisco","94115",{"lat":167,"lon":168},37.77493,-122.41942,{"facility":135,"status":136,"city":170,"state":146,"zip":171,"country":140,"geoPoint":172},"Santa Barbara","93105",{"lat":173,"lon":174},34.42083,-119.69819,{"facility":135,"status":8,"city":176,"state":146,"zip":177,"country":140,"geoPoint":178},"Vallejo","94589",{"lat":179,"lon":180},38.10409,-122.25664,{"facility":135,"status":136,"city":182,"state":183,"zip":184,"country":140,"geoPoint":185},"Aurora","Colorado","80045",{"lat":186,"lon":187},39.72943,-104.83192,{"facility":135,"status":8,"city":189,"state":183,"zip":190,"country":140,"geoPoint":191},"Denver","80220",{"lat":192,"lon":193},39.73915,-104.9847,{"facility":135,"status":8,"city":195,"state":196,"zip":197,"country":140,"geoPoint":198},"New Haven","Connecticut","06511",{"lat":199,"lon":200},41.30815,-72.92816,{"facility":135,"status":8,"city":202,"state":203,"zip":204,"country":140,"geoPoint":205},"Tampa","Florida","33612",{"lat":206,"lon":207},27.94752,-82.45843,{"facility":135,"status":8,"city":209,"state":210,"zip":211,"country":140,"geoPoint":212},"Marietta","Georgia","30060",{"lat":213,"lon":214},33.9526,-84.54993,{"facility":135,"status":8,"city":216,"state":217,"zip":218,"country":140,"geoPoint":219},"Honolulu","Hawaii","96813",{"lat":220,"lon":221},21.30694,-157.85833,{"facility":135,"status":8,"city":223,"state":224,"zip":225,"country":140,"geoPoint":226},"Peoria","Illinois","61615",{"lat":227,"lon":228},40.69365,-89.58899,{"facility":135,"status":8,"city":230,"state":224,"zip":231,"country":140,"geoPoint":232},"Urbana","61801",{"lat":233,"lon":234},40.11059,-88.20727,{"facility":135,"status":136,"city":236,"state":237,"zip":238,"country":140,"geoPoint":239},"Ames","Iowa","50010",{"lat":240,"lon":241},42.03471,-93.61994,{"facility":135,"status":8,"city":243,"state":244,"zip":245,"country":140,"geoPoint":246},"Scarborough","Maine","04074",{"lat":247,"lon":248},43.57814,-70.32172,{"facility":135,"status":8,"city":250,"state":251,"zip":252,"country":140,"geoPoint":253},"Annapolis","Maryland","21401",{"lat":254,"lon":255},38.97859,-76.49184,{"facility":135,"status":136,"city":257,"state":251,"zip":258,"country":140,"geoPoint":259},"Catonsville","21228",{"lat":260,"lon":261},39.27205,-76.73192,{"facility":135,"status":8,"city":263,"state":264,"zip":265,"country":140,"geoPoint":266},"Burlington","Massachusetts","01805",{"lat":267,"lon":268},42.50482,-71.19561,{"facility":135,"status":8,"city":270,"state":271,"zip":272,"country":140,"geoPoint":273},"Minneapolis","Minnesota","55404",{"lat":274,"lon":275},44.97997,-93.26384,{"facility":135,"status":136,"city":277,"state":278,"zip":279,"country":140,"geoPoint":280},"Jackson","Mississippi","39216",{"lat":281,"lon":282},32.29876,-90.18481,{"facility":135,"status":8,"city":284,"state":285,"zip":286,"country":140,"geoPoint":287},"Kansas City","Missouri","64132",{"lat":288,"lon":289},39.09973,-94.57857,{"facility":135,"status":8,"city":291,"state":292,"zip":293,"country":140,"geoPoint":294},"Santa Fe","New Mexico","87505",{"lat":295,"lon":296},35.68698,-105.9378,{"facility":135,"status":136,"city":298,"state":298,"zip":299,"country":140,"geoPoint":300},"New York","10032",{"lat":301,"lon":302},40.71427,-74.00597,{"facility":135,"status":8,"city":304,"state":305,"zip":306,"country":140,"geoPoint":307},"Charlotte","North Carolina","28204",{"lat":308,"lon":309},35.22709,-80.84313,{"facility":135,"status":8,"city":311,"state":312,"zip":313,"country":140,"geoPoint":314},"Cincinnati","Ohio","45245",{"lat":315,"lon":316},39.12711,-84.51439,{"facility":135,"status":8,"city":318,"state":312,"zip":319,"country":140,"geoPoint":320},"Columbus","43219",{"lat":321,"lon":322},39.96118,-82.99879,{"facility":135,"status":136,"city":324,"state":325,"zip":326,"country":140,"geoPoint":327},"Portland","Oregon","97239",{"lat":328,"lon":329},45.52345,-122.67621,{"facility":135,"status":136,"city":331,"state":332,"zip":333,"country":140,"geoPoint":334},"Horsham","Pennsylvania","19044",{"lat":335,"lon":336},40.17844,-75.12851,{"facility":135,"status":8,"city":338,"state":332,"zip":339,"country":140,"geoPoint":340},"Sayre","18840",{"lat":341,"lon":342},41.97896,-76.5155,{"facility":135,"status":8,"city":344,"state":345,"zip":346,"country":140,"geoPoint":347},"Bartlett","Tennessee","38133",{"lat":348,"lon":349},35.20453,-89.87398,{"facility":135,"status":136,"city":351,"state":345,"zip":352,"country":140,"geoPoint":353},"Knoxville","37909",{"lat":354,"lon":355},35.96064,-83.92074,{"facility":135,"status":8,"city":357,"state":345,"zip":358,"country":140,"geoPoint":359},"Mount Juliet","37122",{"lat":360,"lon":361},36.20005,-86.51861,{"facility":135,"status":8,"city":363,"state":345,"zip":364,"country":140,"geoPoint":365},"Nashville","37232",{"lat":366,"lon":367},36.16589,-86.78444,{"facility":135,"status":8,"city":369,"state":345,"zip":370,"country":140,"geoPoint":371},"Tennessee City","37203",{"lat":372,"lon":373},36.09312,-87.51474,{"facility":135,"status":8,"city":375,"state":376,"zip":377,"country":140,"geoPoint":378},"Denton","Texas","76201",{"lat":379,"lon":380},33.21484,-97.13307,{"facility":135,"status":8,"city":382,"state":376,"zip":383,"country":140,"geoPoint":384},"El Paso","79902",{"lat":385,"lon":386},31.75872,-106.48693,{"facility":135,"status":8,"city":388,"state":376,"zip":389,"country":140,"geoPoint":390},"Houston","77024",{"lat":391,"lon":392},29.76328,-95.36327,{"facility":135,"status":136,"city":394,"state":376,"zip":395,"country":140,"geoPoint":396},"San Antonio","78229",{"lat":397,"lon":398},29.42412,-98.49363,{"facility":135,"status":136,"city":400,"state":401,"zip":402,"country":140,"geoPoint":403},"Salt Lake City","Utah","84106",{"lat":404,"lon":405},40.76078,-111.89105,{"facility":135,"status":8,"city":407,"state":408,"zip":409,"country":140,"geoPoint":410},"Fort Belvoir","Virginia","22060",{"lat":411,"lon":412},38.7119,-77.14589,{"facility":135,"status":8,"city":414,"state":408,"zip":415,"country":140,"geoPoint":416},"Midlothian","23114",{"lat":417,"lon":418},37.50598,-77.64916,{"facility":135,"status":8,"city":420,"state":408,"zip":421,"country":140,"geoPoint":422},"Norfolk","23502",{"lat":423,"lon":424},36.84681,-76.28522,{"facility":135,"status":8,"city":426,"state":427,"zip":428,"country":140,"geoPoint":429},"Olympia","Washington","98502",{"lat":430,"lon":431},47.04491,-122.90169,{"facility":135,"status":136,"city":433,"state":427,"zip":434,"country":140,"geoPoint":435},"Vancouver","98684",{"lat":436,"lon":437},45.63873,-122.66149,{"facility":135,"status":136,"city":439,"state":440,"zip":441,"country":140,"geoPoint":442},"Milwaukee","Wisconsin","52336",{"lat":443,"lon":444},43.0389,-87.90647,{"facility":135,"status":8,"city":446,"state":447,"zip":448,"country":449,"geoPoint":450},"Sydney","New South Wales","2109","Australia",{"lat":451,"lon":452},-33.86785,151.20732,{"facility":135,"status":8,"city":454,"state":447,"zip":455,"country":449,"geoPoint":456},"Waratah","2298",{"lat":457,"lon":458},-32.90667,151.72647,{"facility":135,"status":8,"city":460,"state":461,"zip":462,"country":449,"geoPoint":463},"South Brisbane","Queensland","4101",{"lat":464,"lon":465},-27.48034,153.02049,{"facility":135,"status":8,"city":467,"state":468,"zip":469,"country":449,"geoPoint":470},"Adelaide","South Australia","5000",{"lat":471,"lon":472},-34.92866,138.59863,{"facility":135,"status":8,"city":474,"state":475,"zip":476,"country":449,"geoPoint":477},"Clayton","Victoria","3168",{"lat":478,"lon":479},-37.91667,145.11667,{"facility":135,"status":8,"city":481,"state":475,"zip":482,"country":449,"geoPoint":483},"Geelong","3220",{"lat":484,"lon":485},-38.14711,144.36069,{"facility":135,"status":8,"city":487,"state":475,"zip":488,"country":449,"geoPoint":489},"Heidelberg","03084",{"lat":490,"lon":491},-37.75,145.06667,{"facility":135,"status":8,"city":493,"state":494,"zip":495,"country":449,"geoPoint":496},"Nedlands","Western Australia","6009",{"lat":497,"lon":498},-31.98184,115.8073,{"facility":135,"status":136,"city":500,"state":501,"zip":502,"country":503,"geoPoint":504},"Krems","Lower Austria","3500","Austria",{"lat":505,"lon":506},48.40921,15.61415,{"facility":135,"status":136,"city":508,"state":509,"zip":510,"country":503,"geoPoint":511},"Salzburg","State of Salzburg","5020",{"lat":512,"lon":513},47.79941,13.04399,{"facility":135,"status":8,"city":515,"state":516,"zip":517,"country":503,"geoPoint":518},"Linz","Upper Austria","4010",{"lat":519,"lon":520},48.30639,14.28611,{"facility":135,"status":136,"city":522,"state":516,"zip":523,"country":503,"geoPoint":524},"Wels","4600",{"lat":525,"lon":526},48.16667,14.03333,{"facility":135,"status":136,"city":528,"state":529,"zip":530,"country":531,"geoPoint":532},"Brussels","Brussels Capital","1090","Belgium",{"lat":533,"lon":534},50.85045,4.34878,{"facility":135,"status":8,"city":536,"state":529,"zip":537,"country":531,"geoPoint":538},"Woluwe-Saint-Lambert","1200",{"lat":539,"lon":540},50.84389,4.42912,{"facility":135,"status":8,"city":542,"state":543,"zip":544,"country":531,"geoPoint":545},"Kortrijk","Flanders","8500",{"lat":546,"lon":547},50.82803,3.26487,{"facility":135,"status":8,"city":549,"state":550,"zip":551,"country":531,"geoPoint":552},"Liège","Liège Province","4000",{"lat":553,"lon":554},50.63373,5.56749,{"facility":135,"status":8,"city":556,"state":557,"zip":558,"country":531,"geoPoint":559},"Charleroi","Wallonia","6060",{"lat":560,"lon":561},50.41136,4.44448,{"facility":135,"status":8,"city":563,"state":564,"zip":565,"country":566,"geoPoint":567},"Toronto","Ontario","M2J 1V1","Canada",{"lat":568,"lon":569},43.70643,-79.39864,{"facility":135,"status":8,"city":571,"state":572,"zip":573,"country":574,"geoPoint":575},"Hořovice","Central Bohemia","26831","Czechia",{"lat":576,"lon":577},49.83597,13.90268,{"facility":135,"status":136,"city":579,"state":580,"zip":581,"country":574,"geoPoint":582},"Liberec","Liberec Region","46001",{"lat":583,"lon":584},50.76711,15.05619,{"facility":135,"status":136,"city":586,"state":587,"zip":588,"country":574,"geoPoint":589},"Olomouc","Olomouc Region","77900",{"lat":590,"lon":591},49.59552,17.25175,{"facility":135,"status":136,"city":593,"state":593,"zip":594,"country":574,"geoPoint":595},"Prague","150 06",{"lat":596,"lon":597},50.08804,14.42076,{"facility":135,"status":8,"city":599,"state":599,"zip":600,"country":574,"geoPoint":601},"Zlín","762 75",{"lat":602,"lon":603},49.22645,17.67065,{"facility":135,"status":8,"city":605,"state":606,"zip":607,"country":608,"geoPoint":609},"Pierre-Bénite","Auvergne-Rhône-Alpes","69310","France",{"lat":610,"lon":611},45.70359,4.82424,{"facility":135,"status":136,"city":613,"state":614,"zip":615,"country":608,"geoPoint":616},"Brest","Brittany Region","29609",{"lat":617,"lon":618},48.39029,-4.48628,{"facility":135,"status":8,"city":620,"state":614,"zip":621,"country":608,"geoPoint":622},"Plérin","22190",{"lat":623,"lon":624},48.53451,-2.76975,{"facility":135,"status":136,"city":626,"state":627,"zip":628,"country":608,"geoPoint":629},"Besançon","Doubs","25000",{"lat":630,"lon":631},47.24878,6.01815,{"facility":135,"status":8,"city":633,"state":634,"zip":635,"country":608,"geoPoint":636},"Montpellier","Hérault","34070",{"lat":637,"lon":638},43.61093,3.87635,{"facility":135,"status":136,"city":640,"state":641,"zip":642,"country":608,"geoPoint":643},"Toulouse","Occitanie","31059",{"lat":644,"lon":645},43.60426,1.44367,{"facility":135,"status":136,"city":647,"state":648,"zip":649,"country":608,"geoPoint":650},"Marseille","Provence-Alpes-Côte d'Azur Region","13273",{"lat":651,"lon":652},43.29695,5.38107,{"facility":135,"status":8,"city":654,"zip":655,"country":608,"geoPoint":656},"Bobigny","93000",{"lat":657,"lon":658},48.90982,2.45012,{"facility":135,"status":8,"city":660,"state":661,"zip":662,"country":608,"geoPoint":663},"Villejuif","Île-de-France Region","94805",{"lat":664,"lon":665},48.7939,2.35992,{"facility":135,"status":8,"city":667,"state":668,"zip":669,"country":670,"geoPoint":671},"Frankfurt","Hassen","60431","Germany",{"lat":672,"lon":673},49.68333,10.53333,{"facility":135,"status":136,"city":675,"state":676,"zip":677,"country":670,"geoPoint":678},"Düsseldorf","North Rhine-Westphalia","40235",{"lat":679,"lon":680},51.22319,6.77927,{"facility":135,"status":8,"city":682,"state":676,"zip":683,"country":670,"geoPoint":684},"Witten","58452",{"lat":685,"lon":686},51.44362,7.35258,{"facility":135,"status":136,"city":688,"state":689,"zip":690,"country":670,"geoPoint":691},"Torgau","Saxony","04860",{"lat":692,"lon":693},51.56016,12.99617,{"facility":135,"status":8,"city":695,"state":696,"zip":697,"country":698,"geoPoint":699},"Pátrai","Achaia","26504","Greece",{"lat":700,"lon":701},38.2462,21.73508,{"facility":135,"status":8,"city":703,"state":704,"zip":705,"country":698,"geoPoint":706},"Athens","Attica","11528",{"lat":707,"lon":708},37.98376,23.72784,{"facility":135,"status":8,"city":703,"state":710,"zip":711,"country":698,"geoPoint":712},"Pireas","18547",{"lat":707,"lon":708},{"facility":135,"status":8,"city":714,"state":714,"zip":715,"country":698,"geoPoint":716},"Thessaloniki","57001",{"lat":717,"lon":718},40.64072,22.93493,{"facility":135,"status":8,"city":720,"state":720,"zip":721,"country":720,"geoPoint":722},"Hong Kong","999077",{"lat":723,"lon":724},22.27832,114.17469,{"facility":135,"status":8,"city":720,"state":726,"zip":721,"country":720,"geoPoint":727},"Kowloon",{"lat":723,"lon":724},{"facility":135,"status":8,"city":720,"state":729,"zip":721,"country":720,"geoPoint":730},"Pok Fu Lam",{"lat":723,"lon":724},{"facility":135,"status":8,"city":732,"state":733,"zip":734,"country":735,"geoPoint":736},"Kecskemét","Bács-Kiskun county","6000","Hungary",{"lat":737,"lon":738},46.90618,19.69128,{"facility":135,"status":136,"city":740,"state":741,"zip":742,"country":735,"geoPoint":743},"Győr","Győr-Moson-Sopron","9024",{"lat":744,"lon":745},47.68333,17.63512,{"facility":135,"status":8,"city":747,"state":748,"zip":749,"country":735,"geoPoint":750},"Debrecen","Hajdú-Bihar","4032",{"lat":751,"lon":752},47.53167,21.62444,{"facility":135,"status":136,"city":754,"state":755,"zip":756,"country":735,"geoPoint":757},"Szekszárd","Tolna County","7100",{"lat":758,"lon":759},46.34723,18.71189,{"facility":135,"status":136,"city":761,"state":762,"zip":763,"country":764,"geoPoint":765},"Petah Tikva","Central District","4941492","Israel",{"lat":766,"lon":767},32.08707,34.88747,{"facility":135,"status":136,"city":769,"state":769,"zip":770,"country":764,"geoPoint":771},"Jerusalem","91999",{"lat":772,"lon":773},31.76904,35.21633,{"facility":135,"status":136,"city":775,"state":776,"zip":777,"country":764,"geoPoint":778},"Ashdod","Southern District","7747629",{"lat":779,"lon":780},31.79213,34.64966,{"facility":135,"status":136,"city":782,"state":783,"zip":784,"country":785,"geoPoint":786},"Naples","Campania","80131","Italy",{"lat":787,"lon":788},40.85216,14.26811,{"facility":135,"status":8,"city":790,"state":791,"zip":792,"country":785,"geoPoint":793},"Bologna","Emilia-Romagna","40138",{"lat":794,"lon":795},44.49381,11.33875,{"facility":135,"status":136,"city":797,"state":798,"zip":799,"country":785,"geoPoint":800},"Aviano","Friuli Venezia Giulia","33081",{"lat":801,"lon":802},46.07056,12.59472,{"facility":135,"status":8,"city":804,"state":805,"zip":806,"country":785,"geoPoint":807},"Rome","Lazio","00168",{"lat":808,"lon":809},41.89193,12.51133,{"facility":135,"status":8,"city":811,"state":812,"zip":813,"country":785,"geoPoint":814},"Genoa","Liguria","16132",{"lat":815,"lon":816},44.40478,8.94439,{"facility":135,"status":8,"city":818,"state":819,"zip":820,"country":785,"geoPoint":821},"Bergamo","Lombardy","24127",{"lat":822,"lon":823},45.69601,9.66721,{"facility":135,"status":8,"city":825,"state":819,"zip":826,"country":785,"geoPoint":827},"Milan","20141",{"lat":828,"lon":829},45.46427,9.18951,{"facility":135,"status":8,"city":831,"state":819,"zip":832,"country":785,"geoPoint":833},"Monza","20900",{"lat":834,"lon":835},45.58005,9.27246,{"facility":135,"status":8,"city":825,"state":837,"zip":838,"country":785,"geoPoint":839},"Milano","20132",{"lat":840,"lon":841},42.78235,12.59836,{"facility":135,"status":136,"city":843,"state":844,"zip":845,"country":785,"geoPoint":846},"Pisa","Tuscany","56126",{"lat":847,"lon":848},43.70853,10.4036,{"facility":135,"status":136,"city":850,"state":844,"zip":851,"country":785,"geoPoint":852},"Prato","59100",{"lat":853,"lon":854},43.8805,11.09699,{"facility":135,"status":8,"city":825,"state":856,"zip":857,"country":785,"geoPoint":858},"Varese","21100",{"lat":828,"lon":829},{"facility":135,"status":8,"city":860,"state":861,"zip":862,"country":863,"geoPoint":864},"Ipoh","Ipoh Perak","30450","Malaysia",{"lat":865,"lon":866},4.5841,101.0829,{"facility":135,"status":8,"city":868,"state":868,"zip":869,"country":863,"geoPoint":870},"Kuala Lumpur","50586",{"lat":871,"lon":872},3.1412,101.68653,{"facility":135,"status":8,"city":868,"state":868,"zip":851,"country":863,"geoPoint":874},{"lat":871,"lon":872},{"facility":135,"status":8,"city":876,"state":877,"zip":878,"country":863,"geoPoint":879},"George Town","Pulau Pinang","10450",{"lat":880,"lon":881},5.41123,100.33543,{"facility":135,"status":8,"city":883,"state":884,"zip":885,"country":863,"geoPoint":886},"Kota Kinabalu","Sabah","88996",{"lat":887,"lon":888},5.9749,116.0724,{"facility":135,"status":8,"city":890,"state":891,"zip":892,"country":863,"geoPoint":893},"Kuching","Sarawak","93586",{"lat":894,"lon":895},1.55,110.33333,{"facility":135,"status":8,"city":897,"state":898,"zip":899,"country":863,"geoPoint":900},"Petaling Jaya","Selangor","46050",{"lat":901,"lon":902},3.10726,101.60671,{"facility":135,"status":8,"city":904,"state":905,"zip":906,"country":863,"geoPoint":907},"Putrajaya","Wilayah PE","62250",{"lat":908,"lon":909},2.93527,101.69112,{"facility":135,"status":8,"city":911,"state":912,"zip":913,"country":914,"geoPoint":915},"Apeldoorn","Gelderland","7334 DZ","Netherlands",{"lat":916,"lon":917},52.21,5.96944,{"facility":135,"status":8,"city":919,"state":920,"zip":921,"country":914,"geoPoint":922},"Maastricht","Limberg","6202 AZ",{"lat":923,"lon":924},50.84833,5.68889,{"facility":135,"status":136,"city":926,"state":927,"zip":928,"country":914,"geoPoint":929},"Amsterdam","North Holland","1081 HV",{"lat":930,"lon":931},52.37403,4.88969,{"facility":135,"status":8,"city":933,"state":934,"zip":935,"country":936,"geoPoint":937},"Krakow","Lesser Poland Voivodeship","31-826","Poland",{"lat":938,"lon":939},50.06143,19.93658,{"facility":135,"status":8,"city":941,"state":942,"zip":943,"country":936,"geoPoint":944},"Warsaw","Masovian Voivodeship","03-411",{"lat":945,"lon":946},52.22977,21.01178,{"facility":135,"status":8,"city":948,"state":949,"zip":950,"country":936,"geoPoint":951},"Otwock","Mazowieckir","05-400",{"lat":952,"lon":953},52.10577,21.26129,{"facility":135,"status":136,"city":955,"state":956,"zip":957,"country":936,"geoPoint":958},"Rzeszów","Podkarpackie Voivodeship","35-055",{"lat":959,"lon":960},50.04132,21.99901,{"facility":135,"status":8,"city":955,"state":956,"zip":962,"country":936,"geoPoint":963},"35-922",{"lat":959,"lon":960},{"facility":135,"status":8,"city":965,"state":966,"zip":967,"country":936,"geoPoint":968},"Gdansk","Pomeranian Voivodeship","80-952",{"lat":969,"lon":970},54.35227,18.64912,{"facility":135,"status":136,"city":972,"state":973,"zip":974,"country":936,"geoPoint":975},"Brzozów","Woj Podkarpackie","36-200",{"lat":976,"lon":977},49.69501,22.01926,{"facility":135,"status":8,"city":979,"state":980,"zip":981,"country":936,"geoPoint":982},"Lodz","Łódź Voivodeship","90-302",{"lat":983,"lon":984},51.77058,19.47395,{"facility":135,"status":8,"city":986,"state":987,"zip":988,"country":989,"geoPoint":990},"Lisbon","Lisbon District","1099-023","Portugal",{"lat":991,"lon":992},38.72509,-9.1498,{"facility":135,"status":8,"city":994,"state":995,"zip":996,"country":989,"geoPoint":997},"Porto","Porto District","4200-072",{"lat":998,"lon":999},41.1485,-8.61097,{"facility":135,"status":8,"city":994,"state":995,"zip":1001,"country":989,"geoPoint":1002},"4464-513",{"lat":998,"lon":999},{"facility":135,"status":8,"city":1004,"state":1004,"zip":1005,"country":1006,"geoPoint":1007},"Bucharest","11171","Romania",{"lat":1008,"lon":1009},44.43225,26.10626,{"facility":135,"status":8,"city":1011,"state":1012,"zip":1013,"country":1006,"geoPoint":1014},"Cluj-Napoca","Cluj","400641",{"lat":1015,"lon":1016},46.76667,23.6,{"facility":135,"status":136,"city":1018,"state":1019,"zip":1020,"country":1006,"geoPoint":1021},"Ovidiu","Constanța County","905900",{"lat":1022,"lon":1023},44.258,28.56083,{"facility":135,"status":8,"city":1025,"state":1026,"zip":1027,"country":1006,"geoPoint":1028},"Craiova","Dolj","200542",{"lat":1029,"lon":1030},44.31667,23.8,{"facility":135,"status":8,"city":1032,"state":1033,"zip":1034,"country":1006,"geoPoint":1035},"Iași","Iaşi","700106",{"lat":1036,"lon":1037},47.16667,27.6,{"facility":135,"status":8,"city":1039,"state":1040,"zip":1041,"country":1006,"geoPoint":1042},"Timișoara","Timiș County","300239",{"lat":1043,"lon":1044},45.75372,21.22571,{"facility":135,"status":136,"city":1046,"state":1047,"zip":1048,"country":1049,"geoPoint":1050},"Busan","Busan Metropolitan City","49201","South Korea",{"lat":1051,"lon":1052},35.10168,129.03004,{"facility":135,"status":8,"city":1054,"state":1055,"zip":1056,"country":1049,"geoPoint":1057},"Daegu","Daegu Metropolitan City","41404",{"lat":1058,"lon":1059},35.87028,128.59111,{"facility":135,"status":8,"city":1061,"state":1062,"zip":1063,"country":1049,"geoPoint":1064},"Goyang-si","Gyeonggi-do","10408",{"lat":1065,"lon":1066},37.65639,126.835,{"facility":135,"status":8,"city":1068,"state":1062,"zip":1069,"country":1049,"geoPoint":1070},"Seongnam-si","13620",{"lat":1071,"lon":1072},37.43861,127.13778,{"facility":135,"status":8,"city":1074,"state":1062,"zip":1075,"country":1049,"geoPoint":1076},"Suwon","16247",{"lat":1077,"lon":1078},37.29111,127.00889,{"facility":135,"status":136,"city":1080,"state":1062,"zip":1081,"country":1049,"geoPoint":1082},"Yongin-si","16499",{"lat":1083,"lon":1084},37.29686,127.08042,{"facility":135,"status":136,"city":1086,"state":1086,"zip":1087,"country":1049,"geoPoint":1088},"Seoul","02841",{"lat":1089,"lon":1090},37.566,126.9784,{"facility":1092,"status":8,"city":1086,"state":1086,"zip":1093,"country":1049,"geoPoint":1094},"Clinical Trial Site 1","03080",{"lat":1089,"lon":1090},{"facility":1096,"status":8,"city":1086,"state":1086,"zip":1093,"country":1049,"geoPoint":1097},"Clinical Trial Site 2",{"lat":1089,"lon":1090},{"facility":135,"status":8,"city":1086,"state":1086,"zip":1099,"country":1049,"geoPoint":1100},"03722",{"lat":1089,"lon":1090},{"facility":135,"status":8,"city":1086,"state":1102,"zip":1103,"country":1049,"geoPoint":1104},"Seoul Special City","05505",{"lat":1089,"lon":1090},{"facility":135,"status":136,"city":1086,"state":1102,"zip":1106,"country":1049,"geoPoint":1107},"08308",{"lat":1089,"lon":1090},{"facility":135,"status":8,"city":1109,"state":1109,"zip":1110,"country":1111,"geoPoint":1112},"Alicante","3010","Spain",{"lat":1113,"lon":1114},38.34517,-0.48149,{"facility":135,"status":8,"city":1116,"state":1116,"zip":1117,"country":1111,"geoPoint":1118},"Barcelona","08028",{"lat":1119,"lon":1120},41.38879,2.15899,{"facility":135,"status":8,"city":1116,"state":1116,"zip":1122,"country":1111,"geoPoint":1123},"08035",{"lat":1119,"lon":1120},{"facility":135,"status":8,"city":1116,"state":1116,"zip":1125,"country":1111,"geoPoint":1126},"08036",{"lat":1119,"lon":1120},{"facility":135,"status":8,"city":1128,"state":1128,"zip":1129,"country":1111,"geoPoint":1130},"Granada","18012",{"lat":1131,"lon":1132},37.18817,-3.60667,{"facility":135,"status":8,"city":1134,"state":1134,"zip":1135,"country":1111,"geoPoint":1136},"León","24071",{"lat":1137,"lon":1138},42.60003,-5.57032,{"facility":135,"status":8,"city":1140,"state":1140,"zip":1141,"country":1111,"geoPoint":1142},"Lleida","25198",{"lat":1143,"lon":1144},41.61674,0.62218,{"facility":135,"status":8,"city":1146,"state":1146,"zip":1147,"country":1111,"geoPoint":1148},"Madrid","28007",{"lat":1149,"lon":1150},40.4165,-3.70256,{"facility":135,"status":8,"city":1146,"state":1146,"zip":1152,"country":1111,"geoPoint":1153},"28040",{"lat":1149,"lon":1150},{"facility":135,"status":136,"city":1146,"state":1146,"zip":1155,"country":1111,"geoPoint":1156},"28046",{"lat":1149,"lon":1150},{"facility":135,"status":8,"city":1146,"state":1146,"zip":1158,"country":1111,"geoPoint":1159},"28050",{"lat":1149,"lon":1150},{"facility":135,"status":8,"city":1161,"state":1161,"zip":1162,"country":1111,"geoPoint":1163},"Murcia","30120",{"lat":1164,"lon":1165},37.98704,-1.13004,{"facility":135,"status":8,"city":1167,"state":1168,"zip":1169,"country":1111,"geoPoint":1170},"Seville","Sevilla","41009",{"lat":1171,"lon":1172},37.38283,-5.97317,{"facility":135,"status":8,"city":1174,"state":1174,"zip":1175,"country":1111,"geoPoint":1176},"Valencia","46010",{"lat":1177,"lon":1178},39.47391,-0.37966,{"facility":135,"status":8,"city":1180,"state":1180,"zip":1181,"country":1111,"geoPoint":1182},"Zaragoza","50009",{"lat":1183,"lon":1184},41.65606,-0.87734,{"facility":135,"status":8,"city":1186,"state":1187,"zip":1188,"country":1189,"geoPoint":1190},"Chang-hua","Chang Hua","50006","Taiwan",{"lat":1191,"lon":1192},24.07327,120.56276,{"facility":135,"status":8,"city":1194,"state":1195,"zip":1196,"country":1189,"geoPoint":1197},"Kaohsiung City","Sanmin","80756",{"lat":1198,"lon":1199},22.61626,120.31333,{"facility":135,"status":8,"city":1201,"state":1202,"zip":1203,"country":1189,"geoPoint":1204},"Taipei","Special Municipality","11217",{"lat":1205,"lon":1206},25.05306,121.52639,{"facility":135,"status":8,"city":1201,"state":1202,"zip":1208,"country":1189,"geoPoint":1209},"11490",{"lat":1205,"lon":1206},{"facility":135,"status":8,"city":1201,"state":1211,"zip":1212,"country":1189,"geoPoint":1213},"Taipei City","100",{"lat":1205,"lon":1206},{"facility":135,"status":8,"city":1201,"state":1211,"zip":1215,"country":1189,"geoPoint":1216},"10449",{"lat":1205,"lon":1206},{"facility":135,"status":8,"city":1218,"state":1218,"zip":1219,"country":1220,"geoPoint":1221},"Bangkok","10700","Thailand",{"lat":1222,"lon":1223},13.75398,100.50144,{"facility":135,"status":8,"city":1225,"state":1218,"zip":1226,"country":1220,"geoPoint":1227},"Dusit","10300",{"lat":1228,"lon":1229},13.77706,100.51958,{"facility":135,"status":8,"city":1231,"state":1232,"zip":1233,"country":1220,"geoPoint":1234},"Ban Phaeo","Changwat Samut Sakhon","74120",{"lat":1235,"lon":1236},13.59072,100.10748,{"facility":135,"status":8,"city":1238,"state":1239,"zip":1240,"country":1220,"geoPoint":1241},"Hat Yai","Changwat Songkhla","90110",{"lat":1242,"lon":1243},7.00836,100.47668,{"facility":135,"status":8,"city":1245,"state":1245,"zip":1246,"country":1220,"geoPoint":1247},"Chiang Mai","50200",{"lat":1248,"lon":1249},18.79038,98.98468,{"facility":135,"status":8,"city":1251,"state":1252,"zip":1253,"country":1254,"geoPoint":1255},"Brighton","England","BN2 5BE","United Kingdom",{"lat":1256,"lon":1257},50.82838,-0.13947,{"facility":135,"status":8,"city":1259,"state":1252,"zip":1260,"country":1254,"geoPoint":1261},"London","WC1E 6AG",{"lat":1262,"lon":1263},51.50853,-0.12574,{"facility":135,"status":8,"city":1259,"state":1265,"zip":1266,"country":1254,"geoPoint":1267},"Greater London","EC1M 6BQ",{"lat":1262,"lon":1263},{"facility":135,"status":8,"city":1269,"state":1270,"zip":1271,"country":1254,"geoPoint":1272},"Taunton","Somerset","TA1 5DA",{"lat":1273,"lon":1274},51.01494,-3.10293,{"facility":135,"status":8,"city":1276,"state":1277,"zip":1278,"country":1254,"geoPoint":1279},"Guildford","Surrey","GU2 7XX",{"lat":1280,"lon":1281},51.23536,-0.57427,{"facility":135,"status":136,"city":1283,"state":1284,"zip":1285,"country":1254,"geoPoint":1286},"Cardiff","Wales","CF14 2TL",{"lat":1287,"lon":1288},51.48,-3.18,[1290],{"name":13,"role":1291,"phone":1292,"email":1293},"CONTACT","415-651-7206","OPERA-02@olema.com",[1295],{"name":1296,"affiliation":13,"role":1297},"Medical Director, MD","STUDY_DIRECTOR",[],[1300],{"label":1301,"url":1302},"Olema Publications","https:\u002F\u002Folema.com\u002Fscience\u002Fpublications",{"nct_id":4,"conditions":1304,"biomarkers":1306},[1305],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":1308,"prompt_version":1318},{"design":1309,"status":1310,"heading":1311,"summary":1312,"follow_up":1313,"word_count":1314,"commitments":1315,"compensation":1316,"drugs_mentioned":1317},"This is an international, multi-center, randomized, double-blind, active-controlled Phase 3 study. About 1,000 participants will be randomly assigned to one of two treatment groups.","completed","Palazestrant with Ribociclib for Advanced ER+\u002FHER2- Breast Cancer","This study is testing a new combination of medicines, palazestrant and ribociclib, for people with advanced breast cancer that is estrogen receptor-positive (ER+) and HER2-negative (HER2-). It compares this new combination to a standard treatment, letrozole and ribociclib. The goal is to see if the new combination is more effective and safe. You could be eligible if you are an adult with this type of breast cancer that has spread or is locally advanced, and you haven't had prior systemic anti-cancer treatment for advanced disease. The study will measure how long people live without their cancer getting worse (Progression-Free Survival). The study is currently recruiting about 1,000 participants.","Participants will be followed from the date they are randomly assigned until their disease progresses or they pass away, estimated to be up to 3.5 years.",108,"Participants will take study medications daily on a 4-week cycle. The specific number of visits or procedures is not detailed in this record.","Not stated in the trial record.",[30,33,35],"v2"]