[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641095":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":24,"locations":23,"responsibleParty":30,"collaborators":23,"id":34,"slug":23,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":23,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":23,"enrollmentInfo":42,"targetDuration":23,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":23,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":23},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Trastuzumab Rezetecan (T-DXh) as Continued Neoadjuvant Therapy","EXPERIMENTAL","Patients with residual invasive disease after standard 6 cycles of TCbHP neoadjuvant therapy receive 4 cycles of Trastuzumab Rezetecan (T-DXh) 4.8 mg\u002Fkg intravenously every 3 weeks (Q3W), followed by radical surgery. After surgery:\n\n* Patients achieving pathological complete response (pCR) receive 7 additional cycles of T-DXh as adjuvant therapy.\n* Patients not achieving pCR receive investigator-selected adjuvant therapy (optional: trastuzumab + pertuzumab followed by 1 year of pyrotinib).",[13],"Drug: Trastuzumab Rezetecan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Trastuzumab Rezetecan","An anti-HER2 antibody-drug conjugate (ADC) consisting of a humanized HER2-targeting monoclonal antibody (trastuzumab) conjugated to a DNA topoisomerase I inhibitor (SHR169265) via a cleavable tetrapeptide linker.",[9],[21,22],"T-DXh","SHR-A1811",null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Xiaoan Liu","CONTACT","86-25-83714511","liuxiaoan@126.com",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Liu Xiaoan","Professor","100641095",false,"NCT07589699","Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP","A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.\n* Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).\n* Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).\n* Agree to undergo a core needle biopsy.\n* ECOG performance status 0 or 1.\n* Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, AST\u002FALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.\n* No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Male breast cancer or inflammatory breast cancer.\n* Metastatic breast cancer (Stage IV).\n* Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Concurrent other anti-tumor therapy or participation in another clinical trial.\n* Severe non-malignant disease that would affect compliance or place the patient at risk.\n* Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.\n\nHistory of allergic reaction or contraindication to any component of the study drug.\n\n* Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.\n* Any other condition assessed by the investigator as unsuitable for inclusion.","FEMALE","18 Years",{"count":43,"type":44},59,"ESTIMATED","INTERVENTIONAL",[47],"PHASE4","This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg\u002Fkg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.",[50,51,52,53],"Breast Cancer","HER2-positive Breast Cancer","Early-stage Breast Cancer","Locally Advanced Breast Cancer","NOT_YET_RECRUITING","2026-05-11",{"date":57,"type":58},"2026-05-15","ACTUAL",{"date":60,"type":44},"2026-05-31",{"date":62,"type":44},"2031-12-31",{"name":5,"class":6}]