[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600814":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":53,"locations":59,"responsibleParty":351,"collaborators":353,"id":356,"slug":357,"hasResults":358,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":358,"sex":364,"minAge":365,"maxAge":40,"enrollmentInfo":366,"targetDuration":40,"studyType":369,"phases":370,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":85,"whyStopped":40,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":390},{"fullName":5,"class":6},"Jazz Pharmaceuticals","INDUSTRY",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Zanidatamab with paclitaxel","ACTIVE_COMPARATOR","Zanidatamab in combination with chemotherapy paclitaxel",[13,14],"Drug: Zanidatamab","Drug: Paclitaxel",{"label":16,"type":10,"description":17,"interventionNames":18},"Zanidatamab with docetaxel and carboplatin","Zanidatamab in combination with chemotherapy docetaxel and carboplatin",[13,19,20],"Drug: Docetaxel","Drug: Carboplatin",{"label":22,"type":10,"description":23,"interventionNames":24},"Trastuzumab and pertuzumab with docetaxel and carboplatin","Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin",[19,20,25,26],"Drug: Trastuzumab","Drug: Pertuzumab",[28,37,41,44,47,50],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Zanidatamab","Administered intravenously (IV)",[16,9],[34,35,36],"ZW25","JZP598","ZIIHERA®",{"type":29,"name":38,"description":31,"armGroupLabels":39,"otherNames":40},"Paclitaxel",[9],null,{"type":29,"name":42,"description":31,"armGroupLabels":43,"otherNames":40},"Docetaxel",[22,16],{"type":29,"name":45,"description":31,"armGroupLabels":46,"otherNames":40},"Carboplatin",[22,16],{"type":29,"name":48,"description":31,"armGroupLabels":49,"otherNames":40},"Trastuzumab",[22],{"type":29,"name":51,"description":31,"armGroupLabels":52,"otherNames":40},"Pertuzumab",[22],[54],{"name":55,"role":56,"phone":57,"phoneExt":40,"email":58},"Clinical Trial Disclosure & Transparency","CONTACT","215-832-3750","ClinicalTrialDisclosure@JazzPharma.com",[60,74,83,94,104,113,123,133,143,153,163,172,182,191,201,211,221,227,236,246,255,264,274,283,293,305,317,327,336,342],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":40},"Oncology Institute","ACTIVE_NOT_RECRUITING","Long Beach","California","90805","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-118.18923,33.76696,{"lat":72,"lon":71},{"facility":75,"status":62,"city":76,"state":64,"zip":77,"country":66,"countryCode":67,"cosmosGeoPoint":78,"geoPoint":82,"contacts":40},"Cancer & Blood Research Center","Los Alamitos","90720",{"type":69,"coordinates":79},[80,81],-118.07256,33.80307,{"lat":81,"lon":80},{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":66,"countryCode":67,"cosmosGeoPoint":89,"geoPoint":93,"contacts":40},"Rocky Mountain Cancer Centers","RECRUITING","Denver","Colorado","80218",{"type":69,"coordinates":90},[91,92],-104.9847,39.73915,{"lat":92,"lon":91},{"facility":95,"status":85,"city":96,"state":97,"zip":98,"country":66,"countryCode":67,"cosmosGeoPoint":99,"geoPoint":103,"contacts":40},"Holy Cross Hospital","Fort Lauderdale","Florida","33308",{"type":69,"coordinates":100},[101,102],-80.14338,26.12231,{"lat":102,"lon":101},{"facility":105,"status":62,"city":106,"state":97,"zip":107,"country":66,"countryCode":67,"cosmosGeoPoint":108,"geoPoint":112,"contacts":40},"The Oncology Institute","Lakeland","33812",{"type":69,"coordinates":109},[110,111],-81.9498,28.03947,{"lat":111,"lon":110},{"facility":114,"status":85,"city":115,"state":116,"zip":117,"country":66,"countryCode":67,"cosmosGeoPoint":118,"geoPoint":122,"contacts":40},"Accellacare of McFarland","Ames","Iowa","50010",{"type":69,"coordinates":119},[120,121],-93.61994,42.03471,{"lat":121,"lon":120},{"facility":124,"status":62,"city":125,"state":126,"zip":127,"country":66,"countryCode":67,"cosmosGeoPoint":128,"geoPoint":132,"contacts":40},"LSU Health Sciences Center","Shreveport","Louisiana","71103",{"type":69,"coordinates":129},[130,131],-93.75018,32.52515,{"lat":131,"lon":130},{"facility":134,"status":85,"city":135,"state":136,"zip":137,"country":66,"countryCode":67,"cosmosGeoPoint":138,"geoPoint":142,"contacts":40},"New England Cancer Specialists","Scarborough","Maine","04074",{"type":69,"coordinates":139},[140,141],-70.32172,43.57814,{"lat":141,"lon":140},{"facility":144,"status":85,"city":145,"state":146,"zip":147,"country":66,"countryCode":67,"cosmosGeoPoint":148,"geoPoint":152,"contacts":40},"Maryland Oncology Hematology","Laurel","Maryland","20707",{"type":69,"coordinates":149},[150,151],-76.84831,39.09928,{"lat":151,"lon":150},{"facility":154,"status":85,"city":155,"state":156,"zip":157,"country":66,"countryCode":67,"cosmosGeoPoint":158,"geoPoint":162,"contacts":40},"Cancer Partners of Nebraska","Lincoln","Nebraska","68516",{"type":69,"coordinates":159},[160,161],-96.66696,40.8,{"lat":161,"lon":160},{"facility":164,"status":62,"city":165,"state":156,"zip":166,"country":66,"countryCode":67,"cosmosGeoPoint":167,"geoPoint":171,"contacts":40},"Nebraska Cancer Specialists","Omaha","68124",{"type":69,"coordinates":168},[169,170],-95.94043,41.25626,{"lat":170,"lon":169},{"facility":173,"status":62,"city":174,"state":175,"zip":176,"country":66,"countryCode":67,"cosmosGeoPoint":177,"geoPoint":181,"contacts":40},"Astera Cancer Care (Formerly Regional Cancer Care Associates)","East Brunswick","New Jersey","08816",{"type":69,"coordinates":178},[179,180],-74.41598,40.42788,{"lat":180,"lon":179},{"facility":183,"status":85,"city":184,"state":175,"zip":185,"country":66,"countryCode":67,"cosmosGeoPoint":186,"geoPoint":190,"contacts":40},"Medical Oncology Hematology Associates","Newark","19713",{"type":69,"coordinates":187},[188,189],-74.17237,40.73566,{"lat":189,"lon":188},{"facility":192,"status":85,"city":193,"state":194,"zip":195,"country":66,"countryCode":67,"cosmosGeoPoint":196,"geoPoint":200,"contacts":40},"Hematology Oncology Associates of Central New York","Camillus","New York","13031",{"type":69,"coordinates":197},[198,199],-76.3041,43.03923,{"lat":199,"lon":198},{"facility":202,"status":85,"city":203,"state":204,"zip":205,"country":66,"countryCode":67,"cosmosGeoPoint":206,"geoPoint":210,"contacts":40},"Sarah Cannon Research Institute (Nashville)","Nashville","Tennessee","37203",{"type":69,"coordinates":207},[208,209],-86.78444,36.16589,{"lat":209,"lon":208},{"facility":212,"status":85,"city":213,"state":214,"zip":215,"country":66,"countryCode":67,"cosmosGeoPoint":216,"geoPoint":220,"contacts":40},"Texas Oncology DFW","Dallas","Texas","75246",{"type":69,"coordinates":217},[218,219],-96.80667,32.78306,{"lat":219,"lon":218},{"facility":222,"status":62,"city":213,"state":214,"zip":223,"country":66,"countryCode":67,"cosmosGeoPoint":224,"geoPoint":226,"contacts":40},"The University of Texas Southwestern Medical Center","75390",{"type":69,"coordinates":225},[218,219],{"lat":219,"lon":218},{"facility":228,"status":85,"city":229,"state":214,"zip":230,"country":66,"countryCode":67,"cosmosGeoPoint":231,"geoPoint":235,"contacts":40},"Texas Oncology Gulf Coast","Houston","77024",{"type":69,"coordinates":232},[233,234],-95.36327,29.76328,{"lat":234,"lon":233},{"facility":237,"status":85,"city":238,"state":239,"zip":240,"country":66,"countryCode":67,"cosmosGeoPoint":241,"geoPoint":245,"contacts":40},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":69,"coordinates":242},[243,244],-77.30637,38.84622,{"lat":244,"lon":243},{"facility":247,"status":85,"city":248,"state":239,"zip":249,"country":66,"countryCode":67,"cosmosGeoPoint":250,"geoPoint":254,"contacts":40},"Virginia Oncology Associates","Norfolk","23502",{"type":69,"coordinates":251},[252,253],-76.28522,36.84681,{"lat":253,"lon":252},{"facility":256,"status":85,"city":257,"state":239,"zip":258,"country":66,"countryCode":67,"cosmosGeoPoint":259,"geoPoint":263,"contacts":40},"Shenandoah Oncology","Winchester","22601",{"type":69,"coordinates":260},[261,262],-78.16333,39.18566,{"lat":262,"lon":261},{"facility":265,"status":85,"city":266,"state":267,"zip":268,"country":66,"countryCode":67,"cosmosGeoPoint":269,"geoPoint":273,"contacts":40},"Northwest Medical Specialties","Puyallup","Washington","98373",{"type":69,"coordinates":270},[271,272],-122.2929,47.18538,{"lat":272,"lon":271},{"facility":275,"status":85,"city":276,"state":267,"zip":277,"country":66,"countryCode":67,"cosmosGeoPoint":278,"geoPoint":282,"contacts":40},"Northwest Cancer Specialists","Vancouver","98648",{"type":69,"coordinates":279},[280,281],-122.66149,45.63873,{"lat":281,"lon":280},{"facility":284,"status":85,"city":285,"state":286,"zip":287,"country":66,"countryCode":67,"cosmosGeoPoint":288,"geoPoint":292,"contacts":40},"University of Wisconsin","Madison","Wisconsin","53706",{"type":69,"coordinates":289},[290,291],-89.40123,43.07305,{"lat":291,"lon":290},{"facility":294,"status":62,"city":295,"state":296,"zip":297,"country":298,"countryCode":299,"cosmosGeoPoint":300,"geoPoint":304,"contacts":40},"Ospedale San Raffaele","Milan","Lombardy","20132","Italy","IT",{"type":69,"coordinates":301},[302,303],9.18951,45.46427,{"lat":303,"lon":302},{"facility":306,"status":62,"city":307,"state":308,"zip":309,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":40},"Hospital Clínico San Cecilio","Granada","Andalusia","18007","Spain","ES",{"type":69,"coordinates":313},[314,315],-3.60667,37.18817,{"lat":315,"lon":314},{"facility":318,"status":62,"city":319,"state":320,"zip":321,"country":310,"countryCode":311,"cosmosGeoPoint":322,"geoPoint":326,"contacts":40},"Álvaro Cunqueiro Hospital","Vigo","Galicia","36312",{"type":69,"coordinates":323},[324,325],-8.72264,42.23282,{"lat":325,"lon":324},{"facility":328,"status":62,"city":329,"state":40,"zip":330,"country":310,"countryCode":311,"cosmosGeoPoint":331,"geoPoint":335,"contacts":40},"Hospital Universitario Vall d'Hebron","Barcelona","0-8035",{"type":69,"coordinates":332},[333,334],2.15899,41.38879,{"lat":334,"lon":333},{"facility":337,"status":62,"city":307,"state":40,"zip":338,"country":310,"countryCode":311,"cosmosGeoPoint":339,"geoPoint":341,"contacts":40},"Hospital Universitario Clinico San Cecilio,","18016",{"type":69,"coordinates":340},[314,315],{"lat":315,"lon":314},{"facility":343,"status":62,"city":344,"state":40,"zip":345,"country":310,"countryCode":311,"cosmosGeoPoint":346,"geoPoint":350,"contacts":40},"Hosp Beata María Ana de Jesús","Madrid","28007",{"type":69,"coordinates":347},[348,349],-3.70256,40.4165,{"lat":349,"lon":348},{"type":352,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[354],{"name":355,"class":6},"Jazz Pharmaceuticals Ireland Limited","100600814","phase-2-a-phase-2-neoadjuvant-study-of-zanidatamab-in-combination-with-chemotherapy-in-participants-with-her2-positive-breast-cancer-100600814",false,"NCT07102381","A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","EmpowHER 208","Inclusion Criteria:\n\n1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.\n2. Has histologically confirmed HER2-positive breast cancer\n3. Has a known hormone receptor (HR) status of the primary tumor\n4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.\n5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate organ function\n8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.\n9. Adequate contraceptive precautions\n10. Participants with known HIV are eligible unless:\n\n    1. CD4+ T Cell count is less than or equal to 350 microliters (uL)\n    2. Detectable viral load, or\n    3. Receiving protease inhibitors or cobicistat\n\nExclusion Criteria:\n\n1. Has Stage IV (metastatic) breast cancer.\n2. Has bilateral breast cancer.\n3. Has a history of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.\n4. Has uncontrolled hypertension\n5. Has significant symptoms from peripheral neuropathy\n6. Has an active uncontrolled infection\n7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.\n8. Known active hepatitis B or C infection.\n9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.\n10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer\n11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol\n12. Receipt of a live vaccine within 4 weeks prior to enrollment\n13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy","ALL","18 Years",{"count":367,"type":368},125,"ESTIMATED","INTERVENTIONAL",[371],"PHASE2","The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer",[374,375],"HER2-positive Breast Cancer","Breast Cancer",[377,378,379,380],"HER2-positive early breast cancer","invasive breast carcinoma","zanidatamab","breast neoplasm","2026-06-30",{"date":383,"type":384},"2026-07-02","ACTUAL",{"date":386,"type":384},"2025-09-24",{"date":388,"type":368},"2030-08-01",{"name":5,"class":6},30]