[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624947":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":11,"studyPopulation":11,"armGroups":38,"interventions":49,"overallOfficials":11,"centralContacts":59,"locations":11,"responsibleParty":65,"collaborators":11,"id":68,"slug":11,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":11},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response Rate",null,"3 to 8 weeks after neoadjuvant treatment completion",[14,17,20,23,26,29],{"measure":15,"description":11,"timeFrame":16},"3-Year Event-Free Survival (EFS) Rate","3 years after randomization",{"measure":18,"description":11,"timeFrame":19},"Objective Response Rate (ORR)","Within 6 months after randomization",{"measure":21,"description":11,"timeFrame":22},"Event-Free Survival (EFS)","5-10 years",{"measure":24,"description":11,"timeFrame":25},"EORTC QLQ-C30","Within 1 year after randomization",{"measure":27,"description":11,"timeFrame":28},"QLQ-BR23","within 1 year after randomization",{"measure":30,"description":11,"timeFrame":31},"Adverse enents","First dose to 30 days after last dose",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":11,"whoMasked":11},"NONE",[39,44],{"label":40,"type":41,"description":11,"interventionNames":42},"trastuzumab-rezetecan group","EXPERIMENTAL",[43],"Drug: Trastuzumab rezetecan",{"label":45,"type":46,"description":11,"interventionNames":47},"trastuzumab deruxtecan group","ACTIVE_COMPARATOR",[48],"Drug: Trastuzumab deruxtecan",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":11},"DRUG","Trastuzumab rezetecan","Participants will receive Trastuzumab-rezetecan for 8 cycles",[40],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"Trastuzumab deruxtecan","Participants will receive Trastuzumab deruxtecan for 8 cycles",[45],[60],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Zhenzhen Liu","CONTACT","13603862755","zlyyliuzhenzhen0800@zzu.edu.cn",{"type":66,"investigatorFullName":61,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Professor","100624947",false,"NCT07416253","Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer","A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With HER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n1. Female, 18-75 years old, treatment-naive\n2. ECOG PS 0-1\n3. Histologically confirmed HER2+ (IHC 3+ or IHC 2+\u002FISH+) early\u002Flocally advanced breast cancer (AJCC 8th: cT2-cT4 any N cM0) or cT1c N+ cM0; known ER\u002FPR status\n4. Adequate organ function (hematology\u002Fbiochemistry\u002Fcoagulation\u002Furine\u002Fcardiac)\n5. Negative pregnancy test (childbearing women); agree to effective contraception\n6. Sign an informed consent form.\n\nExclusion Criteria:\n\n1. Bbilateral\u002Finflammatory\u002Foccult breast cancer.\n2. Prior anti-tumor therapy (chemotherapy\u002Fradiotherapy\u002Ftargeted therapy, etc.); radical radiotherapy (4 weeks prior) or palliative radiotherapy (2 weeks prior) to first dose.\n3. Concurrent anti-tumor therapy; other malignancies (within past 5 years, except cured basal cell carcinoma\u002Fcervical CIS).\n4. Prior trial participation (past 4 weeks); systemic immunosuppressants\u002Fhormones (\\>10 mg\u002Fday prednisone equivalent, 2 weeks prior; nasal\u002Finhaled steroids excluded).\n5. Live\u002Fattenuated vaccine (past 4 weeks); major non-breast surgery (4 weeks prior, incomplete recovery).\n6. Active\u002Frelapsing autoimmune disease (except controlled hypothyroidism\u002Fwell-managed skin diseases\u002Ftype 1 diabetes); immunodeficiency (HIV+\u002Forgan transplant).\n7. Uncontrolled cardiovascular\u002Fcerebrovascular disease (e.g., MI\u002Fstroke in 6 months, NYHA III-IV heart failure, QTcF \\>470 msec \\[female\\]).\n8. Active ILD\u002Fsevere lung disease; active hepatitis B (HBsAg+ \\& HBV DNA ≥500 IU\u002FmL)\u002Fhepatitis C (HCV RNA+); severe infection requiring anti-infective therapy.\n9. Bleeding\u002Fthrombotic tendency; hypersensitivity to study drugs\u002Fexcipients.\n10. Pregnant\u002Flactating women; women of childbearing potential with positive pregnancy test or refusing contraception.\n11. Other conditions (e.g., uncontrolled hypertension\u002Fdiabetes, neuropsychiatric disorders) deemed unsuitable by the investigator.","FEMALE","18 Years","75 Years",{"count":78,"type":79},68,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg\u002Fkg Q3W) or T-DXd (5.4 mg\u002Fkg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.",[85],"Breast Cancer",[87,88],"HER2 positive","Antibody-drug conjugate","NOT_YET_RECRUITING","2026-02-10",{"date":92,"type":93},"2026-02-18","ACTUAL",{"date":95,"type":79},"2026-03",{"date":97,"type":79},"2030-07",{"name":5,"class":6}]