[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568835":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":70,"studyPopulation":63,"armGroups":71,"interventions":93,"overallOfficials":128,"centralContacts":132,"locations":138,"responsibleParty":371,"collaborators":373,"id":376,"slug":377,"hasResults":378,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":63,"eligibilityCriteria":382,"healthyVolunteers":378,"sex":383,"minAge":384,"maxAge":63,"enrollmentInfo":385,"targetDuration":63,"studyType":388,"phases":389,"briefSummary":392,"conditions":393,"keywords":63,"overallStatus":141,"whyStopped":63,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":63},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Part 1: Number of Participants Experiencing Dose-Limiting Toxicity (DLT)","DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented.","Up to 21 days",{"measure":14,"description":15,"timeFrame":16},"Part 1: Number of Participants with One or More Adverse Events (AEs)","An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.","Up to approximately 36 months",{"measure":18,"description":19,"timeFrame":20},"Part 1: Number of Participants who Discontinue Study Intervention Due to an AE","An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.","Up to approximately 12 months",{"measure":22,"description":23,"timeFrame":16},"Part 2: Objective Response Rate (ORR)","ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR)will be presented.",[25,29,32,35,38,41,44,47,50,53,56,59,61],{"measure":26,"description":27,"timeFrame":28},"Part 1: Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)","Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan ADC.","At designated time points (up to ~13 months)",{"measure":30,"description":31,"timeFrame":28},"Part 1: Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC","Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan ADC.",{"measure":33,"description":34,"timeFrame":28},"Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC","Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan ADC.",{"measure":36,"description":37,"timeFrame":28},"Part 1: Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA)","Blood samples collected at designated time points will be used to determine the Cmax of total patritumab deruxtecan ADA.",{"measure":39,"description":40,"timeFrame":28},"Part 1: Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA","Blood samples collected at designated time points will be used to determine the Ctrough of total patritumab deruxtecan ADA.",{"measure":42,"description":43,"timeFrame":28},"Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA","Blood samples collected at designated time points will be used to determine the AUC of total patritumab deruxtecan ADA.",{"measure":45,"description":46,"timeFrame":28},"Part 1: Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload","Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan free payload.",{"measure":48,"description":49,"timeFrame":28},"Part 1: Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload","Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan free payload.",{"measure":51,"description":52,"timeFrame":28},"Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload","Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan free payload.",{"measure":54,"description":55,"timeFrame":16},"Part 2: Duration of Response (DOR)","For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is alsoc onsidered PD. DOR as assessed by BICR will be presented.",{"measure":57,"description":58,"timeFrame":16},"Part 2: Progression Free Survival (PFS)","PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD)or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.",{"measure":60,"description":15,"timeFrame":16},"Part 2: Number of Participants with One or More AEs",{"measure":62,"description":15,"timeFrame":20},"Part 2: Number of Participants who Discontinue Study Intervention Due to an AE",null,{"allocation":65,"interventionModel":66,"interventionModelDescription":63,"primaryPurpose":67,"observationalModel":63,"timePerspective":63,"maskingInfo":68},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":69,"maskingDescription":63,"whoMasked":63},"NONE","The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.",[72,80,85,90],{"label":73,"type":74,"description":75,"interventionNames":76},"Part 1: Patritumab deruxtecan plus trastuzumab","EXPERIMENTAL","Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.",[77,78,79],"Biological: Patritumab deruxtecan","Biological: Trastuzumab","Biological: Trastuzumab Biosimilar",{"label":81,"type":74,"description":82,"interventionNames":83},"Part 1: Patritumab deruxtecan plus pertuzumab and trastuzumab","Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.",[77,78,79,84],"Biological: Pertuzumab",{"label":86,"type":74,"description":87,"interventionNames":88},"Part 1: Patritumab deruxtecan plus trastuzumab and tucatinib","Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.",[77,78,79,89],"Biological: Tucatinib",{"label":91,"type":74,"description":82,"interventionNames":92},"Part 2: Patritumab deruxtecan plus pertuzumab and trastuzumab",[77,78,79,84],[94,103,109,120,124],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":99},"BIOLOGICAL","Patritumab deruxtecan","Patritumab deruxtecan administered via IV infusion",[81,73,86,91],[100,101,102],"MK-1022","HER3-DXd","U3-1402",{"type":95,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"Trastuzumab","Trastuzumab administered via IV infusion",[81,73,86,91],[108],"Herceptin®",{"type":95,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"Trastuzumab Biosimilar","Trastuzumab biosimilar administered via IV infusion",[81,73,86,91],[114,115,116,117,118,119],"Trazimera®","Ogivri®","Herzuma®","Ontruzant®","Kanjinti®","Hercessi®",{"type":95,"name":121,"description":122,"armGroupLabels":123,"otherNames":63},"Pertuzumab","Pertuzumab administered via IV infusion",[81,91],{"type":95,"name":125,"description":126,"armGroupLabels":127,"otherNames":63},"Tucatinib","Tucatinib administered as oral tablets",[86],[129],{"name":130,"affiliation":5,"role":131},"Medical Director","STUDY_DIRECTOR",[133],{"name":134,"role":135,"phone":136,"phoneExt":63,"email":137},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[139,157,170,183,196,209,224,236,249,258,272,284,296,311,324,333,348,361],{"facility":140,"status":141,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"University of Colorado Anschutz Medical Campus ( Site 0057)","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":148,"coordinates":149},"Point",[150,151],-104.83192,39.72943,{"lat":151,"lon":150},[154],{"name":155,"role":135,"phone":156,"phoneExt":63,"email":63},"Study Coordinator","720-848-1030",{"facility":158,"status":141,"city":159,"state":160,"zip":161,"country":145,"countryCode":146,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Dana-Farber Cancer Institute ( Site 0050)","Boston","Massachusetts","02215",{"type":148,"coordinates":163},[164,165],-71.05977,42.35843,{"lat":165,"lon":164},[168],{"name":155,"role":135,"phone":169,"phoneExt":63,"email":63},"877-338-7425",{"facility":171,"status":141,"city":172,"state":173,"zip":174,"country":145,"countryCode":146,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Rutgers Cancer Institute of New Jersey ( Site 0052)","New Brunswick","New Jersey","08901",{"type":148,"coordinates":176},[177,178],-74.45182,40.48622,{"lat":178,"lon":177},[181],{"name":155,"role":135,"phone":182,"phoneExt":63,"email":63},"732-235-2465",{"facility":184,"status":141,"city":185,"state":186,"zip":187,"country":145,"countryCode":146,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)","Greenville","South Carolina","29605",{"type":148,"coordinates":189},[190,191],-82.39401,34.85262,{"lat":191,"lon":190},[194],{"name":155,"role":135,"phone":195,"phoneExt":63,"email":63},"864-455-3600",{"facility":197,"status":141,"city":198,"state":199,"zip":200,"country":145,"countryCode":146,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Inova Schar Cancer Institute ( Site 0051)","Fairfax","Virginia","22031",{"type":148,"coordinates":202},[203,204],-77.30637,38.84622,{"lat":204,"lon":203},[207],{"name":155,"role":135,"phone":208,"phoneExt":63,"email":63},"571-472-4724",{"facility":210,"status":141,"city":211,"state":212,"zip":213,"country":214,"countryCode":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Kingston General Hospital ( Site 0061)","Kingston","Ontario","K7L 2V7","Canada","CA",{"type":148,"coordinates":217},[218,219],-76.48098,44.22976,{"lat":219,"lon":218},[222],{"name":155,"role":135,"phone":223,"phoneExt":63,"email":63},"6135336541",{"facility":225,"status":141,"city":226,"state":212,"zip":227,"country":214,"countryCode":215,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Princess Margaret Cancer Centre ( Site 0001)","Toronto","M5G 2M9",{"type":148,"coordinates":229},[230,231],-79.39864,43.70643,{"lat":231,"lon":230},[234],{"name":155,"role":135,"phone":235,"phoneExt":63,"email":63},"416-946-4501",{"facility":237,"status":141,"city":238,"state":239,"zip":240,"country":214,"countryCode":215,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Centre Hospitalier de l'Université de Montréal ( Site 0004)","Montreal","Quebec","H2X 3E4",{"type":148,"coordinates":242},[243,244],-73.58781,45.50884,{"lat":244,"lon":243},[247],{"name":155,"role":135,"phone":248,"phoneExt":63,"email":63},"(514)890-8000 x20737",{"facility":250,"status":141,"city":238,"state":239,"zip":251,"country":214,"countryCode":215,"cosmosGeoPoint":252,"geoPoint":254,"contacts":255},"Jewish General Hospital ( Site 0003)","H3T 1E2",{"type":148,"coordinates":253},[243,244],{"lat":244,"lon":243},[256],{"name":155,"role":135,"phone":257,"phoneExt":63,"email":63},"514-340-8222",{"facility":259,"status":141,"city":260,"state":63,"zip":261,"country":262,"countryCode":263,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Rambam Health Care Campus ( Site 0011)","Haifa","3109601","Israel","IL",{"type":148,"coordinates":265},[266,267],34.99928,32.81303,{"lat":267,"lon":266},[270],{"name":155,"role":135,"phone":271,"phoneExt":63,"email":63},"04-7776234",{"facility":273,"status":141,"city":274,"state":63,"zip":275,"country":262,"countryCode":263,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Rabin Medical Center ( Site 0012)","Petah Tikva","4941492",{"type":148,"coordinates":277},[278,279],34.88666,32.0888,{"lat":279,"lon":278},[282],{"name":155,"role":135,"phone":283,"phoneExt":63,"email":63},"+972-505533121",{"facility":285,"status":141,"city":286,"state":63,"zip":287,"country":262,"countryCode":263,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Sheba Medical Center ( Site 0010)","Ramat Gan","5265601",{"type":148,"coordinates":289},[290,291],34.81065,32.08227,{"lat":291,"lon":290},[294],{"name":155,"role":135,"phone":295,"phoneExt":63,"email":63},"03-5304498",{"facility":297,"status":141,"city":298,"state":299,"zip":300,"country":301,"countryCode":302,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Nagoya City University Hospital ( Site 0020)","Nagoya","Aichi-ken","467-8602","Japan","JP",{"type":148,"coordinates":304},[305,306],136.90641,35.18147,{"lat":306,"lon":305},[309],{"name":155,"role":135,"phone":310,"phoneExt":63,"email":63},"+81-52-851-5511",{"facility":312,"status":141,"city":313,"state":63,"zip":314,"country":315,"countryCode":63,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"Seoul National University Hospital ( Site 0030)","Seoul","03080","South Korea",{"type":148,"coordinates":317},[318,319],126.9784,37.566,{"lat":319,"lon":318},[322],{"name":155,"role":135,"phone":323,"phoneExt":63,"email":63},"82-2-2072-0850",{"facility":325,"status":141,"city":313,"state":63,"zip":326,"country":315,"countryCode":63,"cosmosGeoPoint":327,"geoPoint":329,"contacts":330},"Asan Medical Center ( Site 0031)","05505",{"type":148,"coordinates":328},[318,319],{"lat":319,"lon":318},[331],{"name":155,"role":135,"phone":332,"phoneExt":63,"email":63},"+82-2-1688-7575",{"facility":334,"status":141,"city":335,"state":336,"zip":337,"country":338,"countryCode":339,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"University College London Hospital ( Site 0041)","London","Camden","NW1 2PG","United Kingdom","UK",{"type":148,"coordinates":341},[342,343],-0.12574,51.50853,{"lat":343,"lon":342},[346],{"name":155,"role":135,"phone":347,"phoneExt":63,"email":63},"+442034472930",{"facility":349,"status":141,"city":350,"state":351,"zip":352,"country":338,"countryCode":339,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"The Beatson West of Scotland Cancer Centre ( Site 0043)","Glasgow","Glasgow City","G12 0YN",{"type":148,"coordinates":354},[355,356],-4.25763,55.86515,{"lat":356,"lon":355},[359],{"name":155,"role":135,"phone":360,"phoneExt":63,"email":63},"+441413017000",{"facility":362,"status":141,"city":335,"state":363,"zip":364,"country":338,"countryCode":339,"cosmosGeoPoint":365,"geoPoint":367,"contacts":368},"St Bartholomew s Hospital ( Site 0040)","London, City of","EC1A 7BE",{"type":148,"coordinates":366},[342,343],{"lat":343,"lon":342},[369],{"name":155,"role":135,"phone":370,"phoneExt":63,"email":63},"+442073777000",{"type":372,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR",[374],{"name":375,"class":6},"Daiichi Sankyo","100568835","phase-1-study-of-patritumab-deruxtecan-with-other-anticancer-agents-in-participants-with-her2-positive-breast-cancer-that-has-spread-and-cannot-be-surgically-removed-mk-1022-009-100568835",false,"NCT06686394","Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)","HERTHENA-Breast-01: A Phase 1b\u002F2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention\n\nPart 1 Arm 1:\n\n* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment\n\nPart 1 Arm 2:\n\n-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n\nPart 1 Arm 3:\n\n-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.\n\nPart 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Uncontrolled or significant cardiovascular disease\n* Has any history of (noninfectious) interstitial lung disease (ILD)\u002F pneumonitis irrespective of steroid use or has current ILD or suspected ILD\n* Has clinically severe respiratory compromise\n* Has any history of or evidence of any current leptomeningeal disease\n* Has clinically significant corneal disease\n* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection\n* HIV infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Part 1: Evidence of spinal cord compression or brain metastases\n* Part 2: Evidence of spinal cord compression or brain\u002FCNS metastases.\n* Has an active infection requiring systemic therapy\n* Concurrent active HBV and HCV infection\n* Has had major surgical procedure (excluding placement of vascular access) less than 28 days\n\nPart1: Arm 3 ONLY\n\n\\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting","ALL","18 Years",{"count":386,"type":387},181,"ESTIMATED","INTERVENTIONAL",[390,391],"PHASE1","PHASE2","Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:\n\n* About the safety and how well people tolerate of patritumab deruxtecan\n* How many people have the cancer respond (get smaller or go away) to treatment",[394,395],"Breast Neoplasms","Breast Cancer","2026-10-02",{"date":398,"type":399},"2026-10-06","ACTUAL",{"date":401,"type":399},"2025-02-26",{"date":403,"type":387},"2030-04-18",{"name":5,"class":6},18]