[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577387":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":92,"centralContacts":96,"locations":103,"responsibleParty":320,"collaborators":322,"id":325,"slug":326,"hasResults":327,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":101,"eligibilityCriteria":331,"healthyVolunteers":327,"sex":332,"minAge":333,"maxAge":101,"enrollmentInfo":334,"targetDuration":101,"studyType":337,"phases":338,"briefSummary":340,"conditions":341,"keywords":101,"overallStatus":106,"whyStopped":101,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,17,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin","EXPERIMENTAL","In Part 1, participants receive neoadjuvant pembrolizumab 200 mg via intravenous (IV) infusion every 3 weeks (Q3W) plus patritumab deruxtecan via IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg via IV infusion Q3W plus paclitaxel 80 mg\u002Fm\\^2 via IV infusion every week (QW) and carboplatin AUC1.5 mg\u002Fml\u002Fmin via IV infusion QW for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer.",[13,14,15,16],"Biological: Patritumab deruxtecan","Biological: Pembrolizumab","Drug: Paclitaxel","Drug: Carboplatin",{"label":18,"type":10,"description":19,"interventionNames":20},"Part 2, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin","In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion every Q3W plus patritumab deruxtecan (dose to be determined in part 1) IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg\u002Fm\\^2 IV infusion QW and carboplatin AUC1.5 mg\u002Fml\u002Fmin IV infusion QW for 12 weeks. At 3-6 weeks after last dose of neoadjuvant treatment, participants undergo surgery for breast cancer. After surgery, participants receive adjuvant pembrolizumab 400 mg IV every 6 weeks (Q6W) for \\~30 weeks. Additional adjuvant treatment of physician's choice (TPC) may be given to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline BRCA mutation \\[gBRCAm\\] only), capecitabine 1000-1250 mg\u002Fm\\^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg\u002Fm\\^2 (or epirubicin 90 mg\u002Fm\\^2) IV Q3W or every 2 weeks (Q2W) and cyclophosphamide 600 mg\u002Fm\\^2 IV Q3W or Q2W for 4 doses.",[13,14,15,16,21,22,23,24,25],"Drug: Doxorubicin hydrochloride","Drug: Epirubicin hydrochloride","Drug: Cyclophosphamide","Drug: Capecitabine","Drug: Olaparib",{"label":27,"type":10,"description":28,"interventionNames":29},"Part 2, B: Pembrolizumab + paclitaxel + carboplatin → Pembrolizumab + patritumab deruxtecan","In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg\u002Fm\\^2 IV infusion QW and carboplatin AUC1.5 mg\u002Fml\u002Fmin IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus patritumab deruxtecan (dose to be determined in part 1) via IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for \\~30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only), capecitabine 1000-1250 mg\u002Fm\\^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg\u002Fm\\^2 (or epirubicin 90 mg\u002Fm\\^2) IV infusion Q3W or Q2W and cyclophosphamide 600 mg\u002Fm\\^2 IV infusion Q3W or Q2W for 4 doses.",[13,14,15,16,21,22,23,24,25],{"label":31,"type":32,"description":33,"interventionNames":34},"Part 2, C: Pembro + paclitaxel + carboplatin→ Pembro + doxorubicin (or epirubicin) +cyclophosphamide","ACTIVE_COMPARATOR","In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg\u002Fm\\^2 IV infusion QW and carboplatin AUC1.5 mg\u002Fml\u002Fmin via IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus doxorubicin 60mg\u002Fm\\^2 (or epirubicin 90 mg\u002Fm\\^2) IV infusion Q3W and cyclophosphamide 600 mg\u002Fm\\^2 IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for approximately 30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only) or capecitabine 1000-1250 mg\u002Fm\\^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles.",[14,15,16,21,22,23,24,25],[36,45,52,59,64,70,75,80,86],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BIOLOGICAL","Patritumab deruxtecan","Administered via IV infusion as neoadjuvant treatment",[9,18,27],[42,43,44],"MK-1022","HER3-DXd","U3-1402",{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Pembrolizumab","Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2",[9,18,27,31],[50,51],"MK-3475","KEYTRUDA®",{"type":53,"name":54,"description":39,"armGroupLabels":55,"otherNames":56},"DRUG","Paclitaxel",[9,18,27,31],[57,58],"TAXOL®","ONXAL®",{"type":53,"name":60,"description":39,"armGroupLabels":61,"otherNames":62},"Carboplatin",[9,18,27,31],[63],"PARAPLATIN®",{"type":53,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Doxorubicin hydrochloride","Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2",[18,27,31],[69],"ADRIAMYCIN®",{"type":53,"name":71,"description":66,"armGroupLabels":72,"otherNames":73},"Epirubicin hydrochloride",[18,27,31],[74],"ELLENCE®",{"type":53,"name":76,"description":66,"armGroupLabels":77,"otherNames":78},"Cyclophosphamide",[18,27,31],[79],"CYTOXAN®",{"type":53,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Capecitabine","Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2",[18,27,31],[85],"XELODA®",{"type":53,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Olaparib","Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2",[18,27,31],[91],"LYNPARZA®",[93],{"name":94,"affiliation":5,"role":95},"Medical Director","STUDY_DIRECTOR",[97],{"name":98,"role":99,"phone":100,"phoneExt":101,"email":102},"Toll Free Number","CONTACT","1-888-577-8839",null,"Trialsites@msd.com",[104,122,135,148,161,174,187,199,211,224,233,242,257,270,282,296,308],{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"UCLA Hematology\u002FOncology - Parkside ( Site 0021)","RECRUITING","Santa Monica","California","90404","United States","US",{"type":113,"coordinates":114},"Point",[115,116],-118.49138,34.01949,{"lat":116,"lon":115},[119],{"name":120,"role":99,"phone":121,"phoneExt":101,"email":101},"Study Coordinator","424-402-9520",{"facility":123,"status":106,"city":124,"state":125,"zip":126,"country":110,"countryCode":111,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Orchard Healthcare Research Inc. ( Site 0006)","Skokie","Illinois","60077",{"type":113,"coordinates":128},[129,130],-87.73339,42.03336,{"lat":130,"lon":129},[133],{"name":120,"role":99,"phone":134,"phoneExt":101,"email":101},"847-568-9932",{"facility":136,"status":106,"city":137,"state":138,"zip":139,"country":110,"countryCode":111,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)","Billings","Montana","59102",{"type":113,"coordinates":141},[142,143],-108.50069,45.78329,{"lat":143,"lon":142},[146],{"name":120,"role":99,"phone":147,"phoneExt":101,"email":101},"406-238-6685",{"facility":149,"status":106,"city":150,"state":151,"zip":152,"country":110,"countryCode":111,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Northwest Cancer Specialists (Compass Oncology) ( Site 8003)","Tigard","Oregon","97223",{"type":113,"coordinates":154},[155,156],-122.77149,45.43123,{"lat":156,"lon":155},[159],{"name":120,"role":99,"phone":160,"phoneExt":101,"email":101},"360-944-9889",{"facility":162,"status":106,"city":163,"state":164,"zip":165,"country":110,"countryCode":111,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"SCRI Oncology Partners ( Site 7000)","Nashville","Tennessee","37203",{"type":113,"coordinates":167},[168,169],-86.78444,36.16589,{"lat":169,"lon":168},[172],{"name":120,"role":99,"phone":173,"phoneExt":101,"email":101},"844-482-4812",{"facility":175,"status":106,"city":176,"state":177,"zip":178,"country":110,"countryCode":111,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Texas Oncology - DFW ( Site 8000)","Dallas","Texas","75246",{"type":113,"coordinates":180},[181,182],-96.80667,32.78306,{"lat":182,"lon":181},[185],{"name":120,"role":99,"phone":186,"phoneExt":101,"email":101},"214-370-1067",{"facility":188,"status":106,"city":189,"state":177,"zip":190,"country":110,"countryCode":111,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Houston Methodist Hospital ( Site 0022)","Houston","77030",{"type":113,"coordinates":192},[193,194],-95.36327,29.76328,{"lat":194,"lon":193},[197],{"name":120,"role":99,"phone":198,"phoneExt":101,"email":101},"713-441-9948",{"facility":200,"status":106,"city":201,"state":202,"zip":203,"country":110,"countryCode":111,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Virginia Oncology Associates (VOA) ( Site 8001)","Norfolk","Virginia","23502",{"type":113,"coordinates":205},[206,207],-76.28522,36.84681,{"lat":207,"lon":206},[210],{"name":120,"role":99,"phone":173,"phoneExt":101,"email":101},{"facility":212,"status":106,"city":213,"state":101,"zip":214,"country":215,"countryCode":101,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Seoul National University Hospital ( Site 2400)","Seoul","03080","South Korea",{"type":113,"coordinates":217},[218,219],126.9784,37.566,{"lat":219,"lon":218},[222],{"name":120,"role":99,"phone":223,"phoneExt":101,"email":101},"+82220720850",{"facility":225,"status":106,"city":213,"state":101,"zip":226,"country":215,"countryCode":101,"cosmosGeoPoint":227,"geoPoint":229,"contacts":230},"Severance Hospital, Yonsei University Health System ( Site 2402)","03722",{"type":113,"coordinates":228},[218,219],{"lat":219,"lon":218},[231],{"name":120,"role":99,"phone":232,"phoneExt":101,"email":101},"+82222288135",{"facility":234,"status":106,"city":213,"state":101,"zip":235,"country":215,"countryCode":101,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Asan Medical Center ( Site 2401)","05505",{"type":113,"coordinates":237},[218,219],{"lat":219,"lon":218},[240],{"name":120,"role":99,"phone":241,"phoneExt":101,"email":101},"+82230103217",{"facility":243,"status":106,"city":244,"state":245,"zip":246,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)","Badalona","Catalonia","08916","Spain","ES",{"type":113,"coordinates":250},[251,252],2.24741,41.45004,{"lat":252,"lon":251},[255],{"name":120,"role":99,"phone":256,"phoneExt":101,"email":101},"+34934978925",{"facility":258,"status":106,"city":259,"state":260,"zip":261,"country":247,"countryCode":248,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Clinica Universidad de Navarra ( Site 1703)","Madrid","Madrid, Comunidad de","28027",{"type":113,"coordinates":263},[264,265],-3.70256,40.4165,{"lat":265,"lon":264},[268],{"name":120,"role":99,"phone":269,"phoneExt":101,"email":101},"+34913531920",{"facility":271,"status":106,"city":272,"state":101,"zip":273,"country":247,"countryCode":248,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Hospital Universitario Reina Sofia ( Site 1702)","Córdoba","14004",{"type":113,"coordinates":275},[276,277],-4.77275,37.89155,{"lat":277,"lon":276},[280],{"name":120,"role":99,"phone":281,"phoneExt":101,"email":101},"+34 957012408",{"facility":283,"status":106,"city":284,"state":101,"zip":285,"country":286,"countryCode":287,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Taichung Veterans General Hospital ( Site 2502)","Taichung","407","Taiwan","TW",{"type":113,"coordinates":289},[290,291],120.6839,24.1469,{"lat":291,"lon":290},[294],{"name":120,"role":99,"phone":295,"phoneExt":101,"email":101},"+886423592525",{"facility":297,"status":106,"city":298,"state":101,"zip":299,"country":286,"countryCode":287,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"National Cheng Kung University Hospital ( Site 2503)","Tainan","704",{"type":113,"coordinates":301},[302,303],120.21333,22.99083,{"lat":303,"lon":302},[306],{"name":120,"role":99,"phone":307,"phoneExt":101,"email":101},"+88662353535",{"facility":309,"status":106,"city":310,"state":101,"zip":311,"country":286,"countryCode":287,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)","Taipei","112",{"type":113,"coordinates":313},[314,315],121.52639,25.05306,{"lat":315,"lon":314},[318],{"name":120,"role":99,"phone":319,"phoneExt":101,"email":101},"886228970011x1686",{"type":321,"investigatorFullName":101,"investigatorTitle":101,"investigatorAffiliation":101,"oldNameTitle":101,"oldOrganization":101},"SPONSOR",[323],{"name":324,"class":6},"Daiichi Sankyo","100577387","phase-2-study-of-patritumab-deruxtecan-plus-pembrolizumab-with-other-anticancer-agents-in-participants-with-high-risk-early-stage-triple-negative-or-hormone-receptor-low-positiveher-2-negative-breast-cancer-mk-1022-010-herthena-breast-03-100577387",false,"NCT06797635","Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive\u002FHER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)","An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin\u002FPaclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2\n* Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+\u002FHER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load\n* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation\u002Frandomization\n* Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has uncontrolled or significant cardiovascular disease before randomization\n* Has any history of or evidence of any current leptomeningeal carcinomatosis.\n* Has clinically significant corneal disease\n* Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and\u002For multicentric Castleman disease\n* Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection\n* Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n* Has received any prior treatment, including radiation, systemic therapy, and\u002For definitive surgery for currently diagnosed breast cancer\n* Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)\n* Has metastatic (Stage IV) breast cancer or cN3 nodal involvement\n* Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current or suspected ILD\n* Has an active infection requiring systemic therapy\n* Has concurrent active HBV and HCV infection\n* Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness","ALL","18 Years",{"count":335,"type":336},372,"ESTIMATED","INTERVENTIONAL",[339],"PHASE2","Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:\n\n* About the safety of the study treatments and if people tolerate them\n* If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.",[342,343],"Breast Neoplasms","Breast Cancer","2026-05-19",{"date":346,"type":347},"2026-05-20","ACTUAL",{"date":349,"type":347},"2025-03-20",{"date":351,"type":336},"2034-12-31",{"name":5,"class":6},17]