[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606299":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":74,"studyPopulation":35,"armGroups":75,"interventions":92,"overallOfficials":118,"centralContacts":122,"locations":129,"responsibleParty":1858,"collaborators":1860,"id":1863,"slug":1864,"hasResults":1865,"nctId":1866,"briefTitle":1867,"officialTitle":1868,"acronym":35,"eligibilityCriteria":1869,"healthyVolunteers":1865,"sex":1870,"minAge":1871,"maxAge":35,"enrollmentInfo":1872,"targetDuration":35,"studyType":1875,"phases":1876,"briefSummary":1878,"conditions":1879,"keywords":1881,"overallStatus":132,"whyStopped":35,"lastUpdateSubmitDate":1888,"lastUpdatePostDateStruct":1889,"startDateStruct":1892,"completionDateStruct":1894,"leadSponsor":1896,"locationsCount":1897},{"fullName":5,"class":6},"BioNTech SE","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)","PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors \\[RECIST\\] v1.1), or death from any cause, whichever occurs first.","Up to approximately 32 months",{"measure":14,"description":15,"timeFrame":16},"Overall Survival (OS)","OS is defined as the time from randomization to death from any cause.","Up to approximately 49 months",[18,21,24,27,30,33,37,39,41,45,47,51,54,57,60],{"measure":19,"description":20,"timeFrame":16},"Objective Response Rate (ORR) as Assessed by BICR","ORR is defined as the percentage of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) as per RECIST v1.1 is assessed by BICR as best overall response.",{"measure":22,"description":23,"timeFrame":12},"PFS","PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.",{"measure":25,"description":26,"timeFrame":16},"ORR","ORR is defined as the percentage of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response.",{"measure":28,"description":29,"timeFrame":16},"Duration of Response (DOR)","DOR is defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.",{"measure":31,"description":32,"timeFrame":12},"Disease Control Rate (DCR)","DCR is defined as the percentage of participants in whom a confirmed CR or confirmed PR or stable disease (SD) (per RECIST v1.1, SD assessed at least 6 weeks after randomization) is observed as best overall response.",{"measure":34,"description":35,"timeFrame":36},"PFS Rate as Assessed by BICR",null,"At 6, 12, 18, and 24 months",{"measure":38,"description":35,"timeFrame":36},"PFS Rate as Assessed by Investigator",{"measure":40,"description":35,"timeFrame":36},"OS Rate",{"measure":42,"description":43,"timeFrame":44},"Occurrence of Treatment-Emergent Adverse Events (TEAEs) Including Grade Greater than or Equal to (>=) 3, Serious, and Fatal TEAEs by Relationship","TEAEs graded according to United Stated (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)","From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)",{"measure":46,"description":35,"timeFrame":44},"Occurrence of Dose Interruption, Reduction, and Discontinuation of Trial Treatment due to TEAEs (including related TEAEs)",{"measure":48,"description":49,"timeFrame":50},"Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 Questionnaire (QLQ-C30) Global Health Status\u002FQuality-of-Life score (Items 29 and 30)","Global health status or quality of life (QoL) scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for global health status\u002FQoL is high QoL: high score for symptom scale\u002Fitem is high symptomatology or problems).","Baseline up to approximately 49 months",{"measure":52,"description":53,"timeFrame":50},"Change from Baseline in EORTC QLQ-C30 Physical Functioning","Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for functional scale is high\u002Fhealthy level of functioning).",{"measure":55,"description":56,"timeFrame":50},"Change from Baseline in Arm Symptoms Scale of EORTC QLQ-Breast Cancer (BR)42","Arm symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems.",{"measure":58,"description":59,"timeFrame":50},"Change from Baseline in Breast Symptoms Scale of EORTC QLQ-BR42","Breast symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems.",{"measure":61,"description":62,"timeFrame":50},"Change from Baseline in Functional Assessment of Cancer Therapy-General Version (FACT-G) Overall Bother Item (FACT-GP5)","The single-item GP5, that is \"I am bothered by side effects of treatment,\" is rated on a 5-point Likert scale (where 1=not at all and 5=very much) by the participants. A high scale score represents worse outcome.",{"allocation":64,"interventionModel":65,"interventionModelDescription":35,"primaryPurpose":66,"observationalModel":35,"timePerspective":35,"maskingInfo":67},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":68,"maskingDescription":35,"whoMasked":69},"QUADRUPLE",[70,71,72,73],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The study consists of a:\n\n1. Screening period (up to 28 days);\n2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination \\[whichever comes first\\]);\n3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first).\n\nParticipants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors:\n\n* Prior treatment with cancer immunotherapy (yes versus no)\n* On-trial chemotherapy regimen (paclitaxel\u002Fnab-paclitaxel versus gemcitabine plus carboplatin versus eribulin)\n* Geography (East Asia versus the rest of the world \\[ROW\\])\n* PD-L1 status (combined positive score \\[CPS\\] less than \\[\\\u003C\\] 1 versus 1 less than or equal to \\[\\\u003C=\\] CPS \\\u003C10).",[76,86],{"label":77,"type":78,"description":79,"interventionNames":80},"Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy","EXPERIMENTAL","Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen.",[81,82,83,84,85],"Drug: Pumitamig","Drug: Nab-paclitaxel\u002FPaclitaxel","Drug: Gemcitabine","Drug: Carboplatin","Drug: Eribulin",{"label":87,"type":88,"description":89,"interventionNames":90},"Arm 2: Placebo + TPC Chemotherapy","PLACEBO_COMPARATOR","Participants will be administered with matching placebo plus chemotherapy regimen.",[82,83,84,85,91],"Drug: Matching placebo",[93,102,106,109,112,115],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"DRUG","Pumitamig","Solution for intravenous (IV) infusion",[77],[99,100,101],"BNT327","PM8002","BMS-986545",{"type":94,"name":103,"description":104,"armGroupLabels":105,"otherNames":35},"Nab-paclitaxel\u002FPaclitaxel","IV infusion",[77,87],{"type":94,"name":107,"description":104,"armGroupLabels":108,"otherNames":35},"Gemcitabine",[77,87],{"type":94,"name":110,"description":104,"armGroupLabels":111,"otherNames":35},"Carboplatin",[77,87],{"type":94,"name":113,"description":104,"armGroupLabels":114,"otherNames":35},"Eribulin",[77,87],{"type":94,"name":116,"description":104,"armGroupLabels":117,"otherNames":35},"Matching placebo",[87],[119],{"name":120,"affiliation":5,"role":121},"BioNTech Responsible Person","STUDY_DIRECTOR",[123],{"name":124,"role":125,"phone":126,"phoneExt":127,"email":128},"BioNTech clinical trials patient information","CONTACT","+49 6131 9084","0","patients@biontech.de",[130,144,154,163,172,181,190,199,208,218,227,236,245,255,264,273,283,293,303,312,322,332,341,351,359,369,379,388,398,407,415,423,431,439,447,457,464,469,474,479,484,489,494,499,508,517,526,536,542,552,561,570,579,589,598,608,616,625,631,638,642,647,656,661,670,679,687,697,706,715,725,735,746,750,759,768,777,789,799,809,818,824,833,844,853,862,870,879,890,899,908,917,926,932,938,947,953,962,973,982,991,1000,1009,1018,1027,1036,1045,1054,1063,1072,1081,1091,1100,1109,1115,1126,1135,1141,1147,1158,1167,1176,1185,1194,1203,1212,1221,1230,1241,1250,1259,1265,1271,1280,1289,1298,1307,1318,1327,1336,1345,1354,1363,1372,1381,1390,1399,1408,1412,1421,1430,1439,1448,1452,1461,1472,1481,1492,1501,1510,1519,1525,1531,1541,1547,1553,1563,1572,1581,1590,1599,1605,1611,1617,1626,1637,1646,1652,1661,1670,1676,1682,1688,1697,1703,1712,1721,1730,1741,1750,1759,1768,1777,1786,1792,1798,1804,1813,1822,1831,1840,1849],{"facility":131,"status":132,"city":133,"state":134,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":143,"contacts":35},"Highlands Oncology Group","RECRUITING","Springdale","Arkansas","72762","United States","US",{"type":139,"coordinates":140},"Point",[141,142],-94.12881,36.18674,{"lat":142,"lon":141},{"facility":145,"status":132,"city":146,"state":147,"zip":148,"country":136,"countryCode":137,"cosmosGeoPoint":149,"geoPoint":153,"contacts":35},"University Of California - San Diego Moores Cancer Center","La Jolla","California","92037",{"type":139,"coordinates":150},[151,152],-117.2742,32.84727,{"lat":152,"lon":151},{"facility":155,"status":132,"city":156,"state":147,"zip":157,"country":136,"countryCode":137,"cosmosGeoPoint":158,"geoPoint":162,"contacts":35},"Cancer and Blood Specialty Clinic (CBSC)","Los Alamitos","90720-3309",{"type":139,"coordinates":159},[160,161],-118.07256,33.80307,{"lat":161,"lon":160},{"facility":164,"status":132,"city":165,"state":147,"zip":166,"country":136,"countryCode":137,"cosmosGeoPoint":167,"geoPoint":171,"contacts":35},"Cedar Sinai - Samuel Oschin Cancer Center","Los Angeles","90048",{"type":139,"coordinates":168},[169,170],-118.24368,34.05223,{"lat":170,"lon":169},{"facility":173,"status":132,"city":174,"state":147,"zip":175,"country":136,"countryCode":137,"cosmosGeoPoint":176,"geoPoint":180,"contacts":35},"Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center","Palo Alto","94304-2201",{"type":139,"coordinates":177},[178,179],-122.14302,37.44188,{"lat":179,"lon":178},{"facility":182,"status":132,"city":183,"state":147,"zip":184,"country":136,"countryCode":137,"cosmosGeoPoint":185,"geoPoint":189,"contacts":35},"University Of California Davis Health System","Sacramento","95817-2229",{"type":139,"coordinates":186},[187,188],-121.4944,38.58157,{"lat":188,"lon":187},{"facility":191,"status":132,"city":192,"state":147,"zip":193,"country":136,"countryCode":137,"cosmosGeoPoint":194,"geoPoint":198,"contacts":35},"Sansum Clinic","Santa Barbara","93105",{"type":139,"coordinates":195},[196,197],-119.69819,34.42083,{"lat":197,"lon":196},{"facility":200,"status":132,"city":201,"state":147,"zip":202,"country":136,"countryCode":137,"cosmosGeoPoint":203,"geoPoint":207,"contacts":35},"Saint John's Health Center - John Wayne Cancer Institute (JWCI)","Santa Monica","90404-2312",{"type":139,"coordinates":204},[205,206],-118.49138,34.01949,{"lat":206,"lon":205},{"facility":209,"status":132,"city":210,"state":211,"zip":212,"country":136,"countryCode":137,"cosmosGeoPoint":213,"geoPoint":217,"contacts":35},"Florida Cancer Specialists","Fort Myers","Florida","33916",{"type":139,"coordinates":214},[215,216],-81.84059,26.62168,{"lat":216,"lon":215},{"facility":219,"status":132,"city":220,"state":211,"zip":221,"country":136,"countryCode":137,"cosmosGeoPoint":222,"geoPoint":226,"contacts":35},"Cancer Care Centers of Brevard, Inc","Palm Bay","32901",{"type":139,"coordinates":223},[224,225],-80.58866,28.03446,{"lat":225,"lon":224},{"facility":228,"status":132,"city":229,"state":211,"zip":230,"country":136,"countryCode":137,"cosmosGeoPoint":231,"geoPoint":235,"contacts":35},"Sacred Heart Medical Oncology Group","Pensacola","32504",{"type":139,"coordinates":232},[233,234],-87.21691,30.42131,{"lat":234,"lon":233},{"facility":237,"status":132,"city":238,"state":211,"zip":239,"country":136,"countryCode":137,"cosmosGeoPoint":240,"geoPoint":244,"contacts":35},"Florida Cancer Specialists North","St. Petersburg","33701",{"type":139,"coordinates":241},[242,243],-82.67927,27.77086,{"lat":243,"lon":242},{"facility":246,"status":132,"city":247,"state":248,"zip":249,"country":136,"countryCode":137,"cosmosGeoPoint":250,"geoPoint":254,"contacts":35},"Cancer Care Specialists","Decatur","Illinois","62526",{"type":139,"coordinates":251},[252,253],-88.9548,39.84031,{"lat":253,"lon":252},{"facility":256,"status":132,"city":257,"state":248,"zip":258,"country":136,"countryCode":137,"cosmosGeoPoint":259,"geoPoint":263,"contacts":35},"Cancer Care Specialists of Illinois","O'Fallon","62269",{"type":139,"coordinates":260},[261,262],-89.91121,38.59227,{"lat":262,"lon":261},{"facility":265,"status":132,"city":266,"state":248,"zip":267,"country":136,"countryCode":137,"cosmosGeoPoint":268,"geoPoint":272,"contacts":35},"Carle Foundation Hospital d\u002Fb\u002Fa Carle Cancer Center","Urbana","61801",{"type":139,"coordinates":269},[270,271],-88.20727,40.11059,{"lat":271,"lon":270},{"facility":274,"status":132,"city":275,"state":276,"zip":277,"country":136,"countryCode":137,"cosmosGeoPoint":278,"geoPoint":282,"contacts":35},"University Medical Center, Inc. DBA University of Louisville Hospital\u002FJames Graham Brown Cancer Center","Louisville","Kentucky","40202",{"type":139,"coordinates":279},[280,281],-85.75941,38.25424,{"lat":281,"lon":280},{"facility":284,"status":132,"city":285,"state":286,"zip":287,"country":136,"countryCode":137,"cosmosGeoPoint":288,"geoPoint":292,"contacts":35},"New England Cancer Specialists","Westbrook","Maine","04092",{"type":139,"coordinates":289},[290,291],-70.37116,43.67703,{"lat":291,"lon":290},{"facility":294,"status":132,"city":295,"state":296,"zip":297,"country":136,"countryCode":137,"cosmosGeoPoint":298,"geoPoint":302,"contacts":35},"Saint Agnes Hospital, Clinical Research Center","Baltimore","Maryland","21229",{"type":139,"coordinates":299},[300,301],-76.61219,39.29038,{"lat":301,"lon":300},{"facility":304,"status":132,"city":305,"state":296,"zip":306,"country":136,"countryCode":137,"cosmosGeoPoint":307,"geoPoint":311,"contacts":35},"Maryland Oncology Hematology P.A.","Columbia","21044",{"type":139,"coordinates":308},[309,310],-76.83942,39.24038,{"lat":310,"lon":309},{"facility":313,"status":132,"city":314,"state":315,"zip":316,"country":136,"countryCode":137,"cosmosGeoPoint":317,"geoPoint":321,"contacts":35},"Lahey Hospital & Medical Center","Burlington","Massachusetts","01805",{"type":139,"coordinates":318},[319,320],-71.19561,42.50482,{"lat":320,"lon":319},{"facility":323,"status":132,"city":324,"state":325,"zip":326,"country":136,"countryCode":137,"cosmosGeoPoint":327,"geoPoint":331,"contacts":35},"Karmanos Cancer Center","Detroit","Michigan","48201",{"type":139,"coordinates":328},[329,330],-83.04575,42.33143,{"lat":330,"lon":329},{"facility":333,"status":132,"city":334,"state":325,"zip":335,"country":136,"countryCode":137,"cosmosGeoPoint":336,"geoPoint":340,"contacts":35},"Profound Research LLC at Michigan Hematology and Oncology Consultants","Royal Oak","48073",{"type":139,"coordinates":337},[338,339],-83.14465,42.48948,{"lat":339,"lon":338},{"facility":342,"status":132,"city":343,"state":344,"zip":345,"country":136,"countryCode":137,"cosmosGeoPoint":346,"geoPoint":350,"contacts":35},"Healthpartners Regions Specialty Clinics","Saint Louis Park","Minnesota","55426",{"type":139,"coordinates":347},[348,349],-93.34801,44.9483,{"lat":349,"lon":348},{"facility":342,"status":132,"city":352,"state":344,"zip":353,"country":136,"countryCode":137,"cosmosGeoPoint":354,"geoPoint":358,"contacts":35},"Saint Paul","55101-2502",{"type":139,"coordinates":355},[356,357],-93.09327,44.94441,{"lat":357,"lon":356},{"facility":360,"status":132,"city":361,"state":362,"zip":363,"country":136,"countryCode":137,"cosmosGeoPoint":364,"geoPoint":368,"contacts":35},"Saint Luke's Hospital of Kansas City","Kansas City","Missouri","64111",{"type":139,"coordinates":365},[366,367],-94.57857,39.09973,{"lat":367,"lon":366},{"facility":370,"status":132,"city":371,"state":372,"zip":373,"country":136,"countryCode":137,"cosmosGeoPoint":374,"geoPoint":378,"contacts":35},"Oncology Hematology West, PC dba Nebraska Cancer Specialist","Grand Island","Nebraska","68803",{"type":139,"coordinates":375},[376,377],-98.34201,40.92501,{"lat":377,"lon":376},{"facility":380,"status":132,"city":381,"state":372,"zip":382,"country":136,"countryCode":137,"cosmosGeoPoint":383,"geoPoint":387,"contacts":35},"Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists","Omaha","68310",{"type":139,"coordinates":384},[385,386],-95.94043,41.25626,{"lat":386,"lon":385},{"facility":389,"status":132,"city":390,"state":391,"zip":392,"country":136,"countryCode":137,"cosmosGeoPoint":393,"geoPoint":397,"contacts":35},"Summit Medical Group PA","Florham Park","New Jersey","07932",{"type":139,"coordinates":394},[395,396],-74.38821,40.78788,{"lat":396,"lon":395},{"facility":399,"status":132,"city":400,"state":391,"zip":401,"country":136,"countryCode":137,"cosmosGeoPoint":402,"geoPoint":406,"contacts":35},"Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)","Livingston","07039",{"type":139,"coordinates":403},[404,405],-74.31487,40.79593,{"lat":405,"lon":404},{"facility":399,"status":132,"city":408,"state":391,"zip":409,"country":136,"countryCode":137,"cosmosGeoPoint":410,"geoPoint":414,"contacts":35},"Long Branch","07740",{"type":139,"coordinates":411},[412,413],-73.99236,40.30428,{"lat":413,"lon":412},{"facility":399,"status":132,"city":416,"state":391,"zip":417,"country":136,"countryCode":137,"cosmosGeoPoint":418,"geoPoint":422,"contacts":35},"New Brunswick","08901",{"type":139,"coordinates":419},[420,421],-74.45182,40.48622,{"lat":421,"lon":420},{"facility":399,"status":132,"city":424,"state":391,"zip":425,"country":136,"countryCode":137,"cosmosGeoPoint":426,"geoPoint":430,"contacts":35},"Newark","07112",{"type":139,"coordinates":427},[428,429],-74.17237,40.73566,{"lat":429,"lon":428},{"facility":399,"status":132,"city":432,"state":391,"zip":433,"country":136,"countryCode":137,"cosmosGeoPoint":434,"geoPoint":438,"contacts":35},"Somerville","08876",{"type":139,"coordinates":435},[436,437],-74.60988,40.57427,{"lat":437,"lon":436},{"facility":399,"status":132,"city":440,"state":391,"zip":441,"country":136,"countryCode":137,"cosmosGeoPoint":442,"geoPoint":446,"contacts":35},"Toms River","08755",{"type":139,"coordinates":443},[444,445],-74.19792,39.95373,{"lat":445,"lon":444},{"facility":448,"status":132,"city":449,"state":450,"zip":451,"country":136,"countryCode":137,"cosmosGeoPoint":452,"geoPoint":456,"contacts":35},"Paradigm New York Cancer and Blood Specialists","Bay Shore","New York","11706",{"type":139,"coordinates":453},[454,455],-73.24539,40.7251,{"lat":455,"lon":454},{"facility":448,"status":132,"city":450,"state":450,"zip":458,"country":136,"countryCode":137,"cosmosGeoPoint":459,"geoPoint":463,"contacts":35},"10028",{"type":139,"coordinates":460},[461,462],-74.00597,40.71427,{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":465,"country":136,"countryCode":137,"cosmosGeoPoint":466,"geoPoint":468,"contacts":35},"10469",{"type":139,"coordinates":467},[461,462],{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":470,"country":136,"countryCode":137,"cosmosGeoPoint":471,"geoPoint":473,"contacts":35},"11042",{"type":139,"coordinates":472},[461,462],{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":475,"country":136,"countryCode":137,"cosmosGeoPoint":476,"geoPoint":478,"contacts":35},"11210",{"type":139,"coordinates":477},[461,462],{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":480,"country":136,"countryCode":137,"cosmosGeoPoint":481,"geoPoint":483,"contacts":35},"11702",{"type":139,"coordinates":482},[461,462],{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":485,"country":136,"countryCode":137,"cosmosGeoPoint":486,"geoPoint":488,"contacts":35},"11772",{"type":139,"coordinates":487},[461,462],{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":490,"country":136,"countryCode":137,"cosmosGeoPoint":491,"geoPoint":493,"contacts":35},"11776",{"type":139,"coordinates":492},[461,462],{"lat":462,"lon":461},{"facility":448,"status":132,"city":450,"state":450,"zip":495,"country":136,"countryCode":137,"cosmosGeoPoint":496,"geoPoint":498,"contacts":35},"11901",{"type":139,"coordinates":497},[461,462],{"lat":462,"lon":461},{"facility":500,"status":132,"city":501,"state":450,"zip":502,"country":136,"countryCode":137,"cosmosGeoPoint":503,"geoPoint":507,"contacts":35},"Rochester 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Clínica Universidad de Navarra (CUN)","Pamplona","31008",{"type":139,"coordinates":1708},[1709,1710],-1.64323,42.81687,{"lat":1710,"lon":1709},{"facility":1713,"status":132,"city":1714,"state":35,"zip":1715,"country":1630,"countryCode":1631,"cosmosGeoPoint":1716,"geoPoint":1720,"contacts":35},"Hospital Universitari Parc Tauli","Sabadell","8208",{"type":139,"coordinates":1717},[1718,1719],2.10942,41.54329,{"lat":1719,"lon":1718},{"facility":1722,"status":132,"city":1723,"state":35,"zip":1724,"country":1630,"countryCode":1631,"cosmosGeoPoint":1725,"geoPoint":1729,"contacts":35},"Fundación Instituto Valenciano de Oncología","Valencia","46009",{"type":139,"coordinates":1726},[1727,1728],-0.37966,39.47391,{"lat":1728,"lon":1727},{"facility":1731,"status":132,"city":1732,"state":35,"zip":1733,"country":1734,"countryCode":1735,"cosmosGeoPoint":1736,"geoPoint":1740,"contacts":35},"Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust","Brighton","BN2 5BE","United Kingdom","UK",{"type":139,"coordinates":1737},[1738,1739],-0.13947,50.82838,{"lat":1739,"lon":1738},{"facility":1742,"status":132,"city":1743,"state":35,"zip":1744,"country":1734,"countryCode":1735,"cosmosGeoPoint":1745,"geoPoint":1749,"contacts":35},"University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre","Bristol","BS2 8ED",{"type":139,"coordinates":1746},[1747,1748],-2.59665,51.45523,{"lat":1748,"lon":1747},{"facility":1751,"status":132,"city":1752,"state":35,"zip":1753,"country":1734,"countryCode":1735,"cosmosGeoPoint":1754,"geoPoint":1758,"contacts":35},"Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital","Cottingham","HU16 5JQ",{"type":139,"coordinates":1755},[1756,1757],-0.7554,52.50243,{"lat":1757,"lon":1756},{"facility":1760,"status":132,"city":1761,"state":35,"zip":1762,"country":1734,"countryCode":1735,"cosmosGeoPoint":1763,"geoPoint":1767,"contacts":35},"Edinburgh Cancer Centre-Western General Hospital","Edinburgh","EH4 2LF",{"type":139,"coordinates":1764},[1765,1766],-3.19648,55.95206,{"lat":1766,"lon":1765},{"facility":1769,"status":132,"city":1770,"state":35,"zip":1771,"country":1734,"countryCode":1735,"cosmosGeoPoint":1772,"geoPoint":1776,"contacts":35},"St James's University Hospital - Leeds Teaching Hospitals NHS Trust","Leeds","LS9 7TF",{"type":139,"coordinates":1773},[1774,1775],-1.54785,53.79648,{"lat":1775,"lon":1774},{"facility":1778,"status":132,"city":1779,"state":35,"zip":1780,"country":1734,"countryCode":1735,"cosmosGeoPoint":1781,"geoPoint":1785,"contacts":35},"St Bartholomew's Hospital - Barts Health NHS Trust","London","EC1A 7BE",{"type":139,"coordinates":1782},[1783,1784],-0.12574,51.50853,{"lat":1784,"lon":1783},{"facility":1787,"status":132,"city":1779,"state":35,"zip":1788,"country":1734,"countryCode":1735,"cosmosGeoPoint":1789,"geoPoint":1791,"contacts":35},"University College London Hospitals NHS Foundation Trust","NW2 1PG",{"type":139,"coordinates":1790},[1783,1784],{"lat":1784,"lon":1783},{"facility":1793,"status":132,"city":1779,"state":35,"zip":1794,"country":1734,"countryCode":1735,"cosmosGeoPoint":1795,"geoPoint":1797,"contacts":35},"The Royal Free Hospital - Royal Free London NHS Foundation Trust","NW3 2QG",{"type":139,"coordinates":1796},[1783,1784],{"lat":1784,"lon":1783},{"facility":1799,"status":132,"city":1779,"state":35,"zip":1800,"country":1734,"countryCode":1735,"cosmosGeoPoint":1801,"geoPoint":1803,"contacts":35},"Sarah Cannon Research Institute","W1G 6AD",{"type":139,"coordinates":1802},[1783,1784],{"lat":1784,"lon":1783},{"facility":1805,"status":132,"city":1806,"state":35,"zip":1807,"country":1734,"countryCode":1735,"cosmosGeoPoint":1808,"geoPoint":1812,"contacts":35},"Churchill Hospital - Oxford University Hospitals NHS Foundation Trust","Oxford","OX3 7LE",{"type":139,"coordinates":1809},[1810,1811],-1.25596,51.75222,{"lat":1811,"lon":1810},{"facility":1814,"status":132,"city":1815,"state":35,"zip":1816,"country":1734,"countryCode":1735,"cosmosGeoPoint":1817,"geoPoint":1821,"contacts":35},"North Wales Cancer Treatment C - Glan Clwyd Hospital","Rhyl","LL18 5UJ",{"type":139,"coordinates":1818},[1819,1820],-3.49228,53.31929,{"lat":1820,"lon":1819},{"facility":1823,"status":132,"city":1824,"state":35,"zip":1825,"country":1734,"countryCode":1735,"cosmosGeoPoint":1826,"geoPoint":1830,"contacts":35},"Southampton General Hospital - University Hospital Southampton NHS Foundation Trust","Southampton","SO16 6YD",{"type":139,"coordinates":1827},[1828,1829],-1.40428,50.90395,{"lat":1829,"lon":1828},{"facility":1832,"status":132,"city":1833,"state":35,"zip":1834,"country":1734,"countryCode":1735,"cosmosGeoPoint":1835,"geoPoint":1839,"contacts":35},"Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust","Stoke-on-Trent","ST4 6QG",{"type":139,"coordinates":1836},[1837,1838],-2.18538,53.00415,{"lat":1838,"lon":1837},{"facility":1841,"status":132,"city":1842,"state":35,"zip":1843,"country":1734,"countryCode":1735,"cosmosGeoPoint":1844,"geoPoint":1848,"contacts":35},"Torbay Hosptial, South Devon Healthcare NHS Foundation Trust","Torquay","TQ2 7AA",{"type":139,"coordinates":1845},[1846,1847],-3.52522,50.46198,{"lat":1847,"lon":1846},{"facility":1850,"status":132,"city":1851,"state":35,"zip":1852,"country":1734,"countryCode":1735,"cosmosGeoPoint":1853,"geoPoint":1857,"contacts":35},"New Cross Hospital - The Royal Wolverhampton NHS Trust","Wolverhampton","WV10 0QP",{"type":139,"coordinates":1854},[1855,1856],-2.12296,52.58547,{"lat":1856,"lon":1855},{"type":1859,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[1861],{"name":1862,"class":6},"Bristol-Myers Squibb","100606299","phase-3-rosetta-breast-01-the-effects-and-safety-of-pumitamig-in-patients-with-triple-negative-breast-cancer-100606299",false,"NCT07173751","ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer","A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease","Inclusion Criteria:\n\n* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.\n* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and\u002For progesterone receptor \\[PgR\\]) 1% to 10%, HER2 immunohistochemistry \\[IHC\\] 0, 1+, or 2+ with fluorescence in situ hybridization \\[FISH\\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n* Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Have received any of the following therapies or drugs prior to the initiation of trial:\n\n  * Have received prior systemic anticancer therapy for advanced disease.\n  * Have received prior treatment with a PD(L)-1\u002Fvascular endothelial growth factor (VEGF) bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \\[mg\\]\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.\n  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.\n* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.\n* Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.","ALL","18 Years",{"count":1873,"type":1874},558,"ESTIMATED","INTERVENTIONAL",[1877],"PHASE3","This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.",[1880],"Breast Neoplasms",[1882,1883,1884,1885,1886,1887],"Metastatic TNBC","Bispecific antibody","Programmed death-ligand 1 (PD-L1)","Immunotherapy","Immunotherapy in combination with chemotherapy","Combination with other investigational agents","2026-09-16",{"date":1890,"type":1891},"2026-09-17","ACTUAL",{"date":1893,"type":1891},"2025-10-30",{"date":1895,"type":1874},"2030-09",{"name":5,"class":6},202]