[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587345":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":51,"centralContacts":55,"locations":60,"responsibleParty":73,"collaborators":34,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":34,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":34,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":62,"whyStopped":34,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1：SHR-A1811+Pertuzumab","EXPERIMENTAL","Participants will receive SHR-A1811+Pertuzumab for 6 cycles.",[13,14],"Drug: SHR-A1811","Drug: Pertuzumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2：SHR-A1811+Pertuzumab+Albumin-Paclitaxel","Participants will receive SHR-A1811+Pertuzumab+Albumin-Paclitaxel for 6 cycles.",[13,14,19],"Drug: Albumin-Paclitaxel",{"label":21,"type":22,"description":23,"interventionNames":24},"Cohort 3：TCbHP","ACTIVE_COMPARATOR","Participants will receive Docetaxel +Carboplatin +Trastuzumab +Pertuzumab for 6 cycles.",[14,25,26,27],"Drug: Docetaxel","Drug: Carboplatin","Drug: Trastuzumab",[29,35,38,42,45,48],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","SHR-A1811","an anti-HER2 antibody-drug conjugate (ADC)",[9,16],null,{"type":30,"name":36,"description":36,"armGroupLabels":37,"otherNames":34},"Pertuzumab",[9,16,21],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":34},"Albumin-Paclitaxel","Nab paclitaxel",[16],{"type":30,"name":43,"description":43,"armGroupLabels":44,"otherNames":34},"Docetaxel",[21],{"type":30,"name":46,"description":46,"armGroupLabels":47,"otherNames":34},"Carboplatin",[21],{"type":30,"name":49,"description":49,"armGroupLabels":50,"otherNames":34},"Trastuzumab",[21],[52],{"name":53,"affiliation":5,"role":54},"Zhenzhen Liu","PRINCIPAL_INVESTIGATOR",[56],{"name":53,"role":57,"phone":58,"phoneExt":34,"email":59},"CONTACT","86+13603862755","liuzhenzhen73@126.com",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":34,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":34},"RECRUITING","Zhengzhou","Henan","China","CN",{"type":68,"coordinates":69},"Point",[70,71],113.64861,34.75778,{"lat":71,"lon":70},{"type":54,"investigatorFullName":53,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Professor","100587345","phase-2-shr-a1811-plus-pertuzumab-in-the-neoadjuvant-treatment-of-her2-positive-bc-100587345",false,"NCT06927180","SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC","SHR-A1811 Plus Pertuzumab in Combination With or Without Albumin-paclitaxel as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Randomized, Open-label, Phase II Trial.","Inclusion Criteria:\n\n* Age: 18-70 years old, ECOG 0-1 point.\n* Clinical T2-T4, with any LN, M0.\n* HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \\[FISH\\] in the pathological test\u002Freview of the primary focus conducted by the Pathology Department of the Research Center Hospital).\n* Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.\n* Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy：Absolute value of neutrophil count ≥ 1.5 × 10\\^9\u002FL; Hemoglobin ≥ 90g\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Total bilirubin≤1.5 ULN (upper limit of normal value); Creatinine≤1.5 × ULN; AST\u002FALT ≤ 2.5 × ULN.\n* Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 50%).\n* Women of childbearing age tested negative for serum pregnancy test 7 days before randomization.\n* Sign an informed consent form.\n\nExclusion Criteria:\n\n* Stage IV (metastatic) breast cancer.\n* Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.\n* The patient has a second primary malignant tumor, except for fully treated skin cancer.\n* The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.\n* The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (NYHA III or IV), myocardial infarction or cerebral infarction, pulmonary embolism, unstable angina, or arrhythmia requiring treatment at the time of screening; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block or QTc interphase (F method) \\> 470 msec (female); Atrial fibrillation (EHRA grade ≥2b); Unmanageable hypertension, which the investigators judged unsuitable for study participation.\n* Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.\n* Individuals with a known history of allergies to the drug components of this protocol;\n* Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.","ALL","18 Years","70 Years",{"count":86,"type":87},180,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are:\n\n* Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment?\n* Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer.\n\nSubjects will be randomly assigned 1:1:1 to：\n\n* cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles;\n* cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles;\n* cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[93],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[95,96,97,31,36,39],"Breast Cancer","HER2-positive Breast Cancer","pathologic complete response","2025-06-20",{"date":100,"type":101},"2025-06-23","ACTUAL",{"date":103,"type":101},"2025-04-16",{"date":105,"type":87},"2030-12-01",{"name":5,"class":6},1]