[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06797635":3,"trial-entities:NCT06797635":354,"trial-summary:NCT06797635":17},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":90,"secondary_outcomes":114,"sex":131,"minimum_age":132,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":133,"std_ages":158,"locations":161,"central_contacts":340,"overall_officials":345,"references":349,"see_also_links":350},"NCT06797635","1022-010","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)","RECRUITING","2034-12-31","2026-05","2026-05-20","2025-03-20","Merck Sharp & Dohme LLC","INDUSTRY",false,"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.",null,[19,20],"Breast Neoplasms","Breast Cancer",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},372,"ESTIMATED",[30,42,50,57,62,68,73,78,84],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":38},"BIOLOGICAL","Patritumab deruxtecan","Administered via IV infusion as neoadjuvant treatment",[35,36,37],"Part 1, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin","Part 2, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin","Part 2, B: Pembrolizumab + paclitaxel + carboplatin → Pembrolizumab + patritumab deruxtecan",[39,40,41],"MK-1022","HER3-DXd","U3-1402",{"type":31,"name":43,"description":44,"armGroupLabels":45,"otherNames":47},"Pembrolizumab","Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2",[35,36,37,46],"Part 2, C: Pembro + paclitaxel + carboplatin→ Pembro + doxorubicin (or epirubicin) +cyclophosphamide",[48,49],"MK-3475","KEYTRUDA®",{"type":51,"name":52,"description":33,"armGroupLabels":53,"otherNames":54},"DRUG","Paclitaxel",[35,36,37,46],[55,56],"TAXOL®","ONXAL®",{"type":51,"name":58,"description":33,"armGroupLabels":59,"otherNames":60},"Carboplatin",[35,36,37,46],[61],"PARAPLATIN®",{"type":51,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"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",[36,37,46],[67],"ADRIAMYCIN®",{"type":51,"name":69,"description":64,"armGroupLabels":70,"otherNames":71},"Epirubicin hydrochloride",[36,37,46],[72],"ELLENCE®",{"type":51,"name":74,"description":64,"armGroupLabels":75,"otherNames":76},"Cyclophosphamide",[36,37,46],[77],"CYTOXAN®",{"type":51,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Capecitabine","Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2",[36,37,46],[83],"XELODA®",{"type":51,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Olaparib","Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2",[36,37,46],[89],"LYNPARZA®",[91,95,99,103,106,110],{"measure":92,"description":93,"timeFrame":94},"Part 1: Number of Participants Experiencing an Adverse Event (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 experience an AE will be presented for Part 1.","Up to ~43 weeks",{"measure":96,"description":97,"timeFrame":98},"Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)","A DLT is defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, assessed by investigator as drug-related: Grade (gr) 3 or 4 nonhematologic toxicity (with exceptions); gr 3 or gr 4 laboratory values (with exceptions); gr 3 or 4 febrile neutropenia; prolonged delay (\\>2 weeks) in initiating Cycle 2 (cycle length = 3 weeks) due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1; interstitial lung disease as per investigator; any other gr ≥3 pulmonary toxicity; or gr 5 toxicity.","Up to 21 days",{"measure":100,"description":101,"timeFrame":102},"Part 1: Number of Participants who Discontinued Study Treatment 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 discontinued study treatment due to an AE will be presented for Part 1.","Up to ~30 weeks",{"measure":104,"description":105,"timeFrame":102},"Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0\u002FTis ypN0","pCR (ypT0\u002FTis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery.",{"measure":107,"description":108,"timeFrame":109},"Part 2: Number of Participants Experiencing 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 experience an AE will be presented for Part 2.","Up to ~103 weeks",{"measure":111,"description":112,"timeFrame":113},"Part 2: Number of Participants who Discontinued Study Treatment 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 discontinued study treatment due to an AE will be presented for Part 2.","Up to ~90 weeks",[115,118,122,125,128],{"measure":116,"description":117,"timeFrame":102},"Part 2: pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0","pCR-no DCIS (ypT0 ypN0) is defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery.",{"measure":119,"description":120,"timeFrame":121},"Part 2: Event-Free Survival (EFS)","EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.","Up to ~100 months",{"measure":123,"description":124,"timeFrame":121},"Part 2: Overall Survival (OS)","OS is defined as the time from randomization to date of death due to any cause.",{"measure":126,"description":127,"timeFrame":121},"Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS)","DPDRFS is defined as the time from randomization to first distant progression or distant recurrence event as assessed or death due to any cause, whichever occurs first.",{"measure":129,"description":130,"timeFrame":102},"Part 2: Residual Cancer Burden (RCB)","RCB is defined as residual disease in either the breast or lymph node at the time of surgery. RCB score provides a continuous measurement of the extent of residual cancer. There are four RCB classes: RCB-0 (RCB score 0), RCB-1 (0\\\u003C RCB score \\\u003C1.36), RCB-2 (1.36 \\\u003CRCB score \\\u003C3.28), and RCB-3 (RCB score \\>3.28).","ALL","18 Years",{"inclusion":134,"exclusion":141,"raw_text":157},[135,136,137,138,139,140],"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","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","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","Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation\u002Frandomization","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",[142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"Has uncontrolled or significant cardiovascular disease before randomization","Has any history of or evidence of any current leptomeningeal carcinomatosis.","Has clinically significant corneal disease","Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and\u002For multicentric Castleman disease","Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection","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","Has received any prior treatment, including radiation, systemic therapy, and\u002For definitive surgery for currently diagnosed breast cancer","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)","Has metastatic (Stage IV) breast cancer or cN3 nodal involvement","Has known additional malignancy that is progressing or has required active treatment within the past 5 years","Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis","Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current or suspected ILD","Has an active infection requiring systemic therapy","Has concurrent active HBV and HCV infection","Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness","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",[159,160],"ADULT","OLDER_ADULT",[162,176,187,198,209,220,231,241,251,262,269,276,288,299,309,320,330],{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":167,"contacts":168,"geoPoint":173},"UCLA Hematology\u002FOncology - Parkside ( Site 0021)","Santa Monica","California","90404","United States",[169],{"name":170,"role":171,"phone":172},"Study Coordinator","CONTACT","424-402-9520",{"lat":174,"lon":175},34.01949,-118.49138,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":167,"contacts":181,"geoPoint":184},"Orchard Healthcare Research Inc. ( Site 0006)","Skokie","Illinois","60077",[182],{"name":170,"role":171,"phone":183},"847-568-9932",{"lat":185,"lon":186},42.03336,-87.73339,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":167,"contacts":192,"geoPoint":195},"Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)","Billings","Montana","59102",[193],{"name":170,"role":171,"phone":194},"406-238-6685",{"lat":196,"lon":197},45.78329,-108.50069,{"facility":199,"status":8,"city":200,"state":201,"zip":202,"country":167,"contacts":203,"geoPoint":206},"Northwest Cancer Specialists (Compass Oncology) ( Site 8003)","Tigard","Oregon","97223",[204],{"name":170,"role":171,"phone":205},"360-944-9889",{"lat":207,"lon":208},45.43123,-122.77149,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":167,"contacts":214,"geoPoint":217},"SCRI Oncology Partners ( Site 7000)","Nashville","Tennessee","37203",[215],{"name":170,"role":171,"phone":216},"844-482-4812",{"lat":218,"lon":219},36.16589,-86.78444,{"facility":221,"status":8,"city":222,"state":223,"zip":224,"country":167,"contacts":225,"geoPoint":228},"Texas Oncology - DFW ( Site 8000)","Dallas","Texas","75246",[226],{"name":170,"role":171,"phone":227},"214-370-1067",{"lat":229,"lon":230},32.78306,-96.80667,{"facility":232,"status":8,"city":233,"state":223,"zip":234,"country":167,"contacts":235,"geoPoint":238},"Houston Methodist Hospital ( Site 0022)","Houston","77030",[236],{"name":170,"role":171,"phone":237},"713-441-9948",{"lat":239,"lon":240},29.76328,-95.36327,{"facility":242,"status":8,"city":243,"state":244,"zip":245,"country":167,"contacts":246,"geoPoint":248},"Virginia Oncology Associates (VOA) ( Site 8001)","Norfolk","Virginia","23502",[247],{"name":170,"role":171,"phone":216},{"lat":249,"lon":250},36.84681,-76.28522,{"facility":252,"status":8,"city":253,"zip":254,"country":255,"contacts":256,"geoPoint":259},"Seoul National University Hospital ( Site 2400)","Seoul","03080","South Korea",[257],{"name":170,"role":171,"phone":258},"+82220720850",{"lat":260,"lon":261},37.566,126.9784,{"facility":263,"status":8,"city":253,"zip":264,"country":255,"contacts":265,"geoPoint":268},"Severance Hospital, Yonsei University Health System ( Site 2402)","03722",[266],{"name":170,"role":171,"phone":267},"+82222288135",{"lat":260,"lon":261},{"facility":270,"status":8,"city":253,"zip":271,"country":255,"contacts":272,"geoPoint":275},"Asan Medical Center ( Site 2401)","05505",[273],{"name":170,"role":171,"phone":274},"+82230103217",{"lat":260,"lon":261},{"facility":277,"status":8,"city":278,"state":279,"zip":280,"country":281,"contacts":282,"geoPoint":285},"Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)","Badalona","Catalonia","08916","Spain",[283],{"name":170,"role":171,"phone":284},"+34934978925",{"lat":286,"lon":287},41.45004,2.24741,{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":281,"contacts":293,"geoPoint":296},"Clinica Universidad de Navarra ( Site 1703)","Madrid","Madrid, Comunidad de","28027",[294],{"name":170,"role":171,"phone":295},"+34913531920",{"lat":297,"lon":298},40.4165,-3.70256,{"facility":300,"status":8,"city":301,"zip":302,"country":281,"contacts":303,"geoPoint":306},"Hospital Universitario Reina Sofia ( Site 1702)","Córdoba","14004",[304],{"name":170,"role":171,"phone":305},"+34 957012408",{"lat":307,"lon":308},37.89155,-4.77275,{"facility":310,"status":8,"city":311,"zip":312,"country":313,"contacts":314,"geoPoint":317},"Taichung Veterans General Hospital ( Site 2502)","Taichung","407","Taiwan",[315],{"name":170,"role":171,"phone":316},"+886423592525",{"lat":318,"lon":319},24.1469,120.6839,{"facility":321,"status":8,"city":322,"zip":323,"country":313,"contacts":324,"geoPoint":327},"National Cheng Kung University Hospital ( Site 2503)","Tainan","704",[325],{"name":170,"role":171,"phone":326},"+88662353535",{"lat":328,"lon":329},22.99083,120.21333,{"facility":331,"status":8,"city":332,"zip":333,"country":313,"contacts":334,"geoPoint":337},"Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)","Taipei","112",[335],{"name":170,"role":171,"phone":336},"886228970011x1686",{"lat":338,"lon":339},25.05306,121.52639,[341],{"name":342,"role":171,"phone":343,"email":344},"Toll Free Number","1-888-577-8839","Trialsites@msd.com",[346],{"name":347,"affiliation":13,"role":348},"Medical Director","STUDY_DIRECTOR",[],[351],{"label":352,"url":353},"Merck Clinical Trials Information","http:\u002F\u002Fwww.merckclinicaltrials.com",{"nct_id":4,"conditions":355,"biomarkers":357},[356],"Breast Carcinoma",[]]