[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433855":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Wuhan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ECPy-THP Programs","EXPERIMENTAL","Epirubicin 100 mg\u002Fm2, iv cyclophosphamide 600 mg\u002Fm2, iv + Pyrotinib 400 mg\u002Fd, po 4-week treatment, sequential docetaxel 80 mg\u002Fm2, iv + trastuzumab 6 mg\u002Fkg (first dose 8 mg\u002Fkg), iv + patuximab 420 mg (first dose 840 mg), iv ,po 4 weeks of treatment",[13],"Drug: Pyrotinib Maleate Tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pyrotinib Maleate Tablets","Addition of Pyrotinib in the EC phase to the standard treatment EC-THP regimen recommended by the guidelines.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Hou jinxuan","CONTACT","+86 13971431260","jhou@whu.edu.cn",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Gaosong Wu, Ph D, MD","Director","100433855","phase-4-exploratory-study-of-neoadjuvant-treatment-of-her2-positive-breast-cancer-with-py-in-combination-with-hp-100433855",false,"NCT04929548","Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP","Exploratory Study of Triple-targeted Neoadjuvant Treatment of HER2-positive Breast Cancer With Pyrotinib in Combination With Trastuzumab and Pertuzumab","Inclusion Criteria:\n\n* Female patients aged 18-70 years.\n* ECOG score must be 0 or 1.\n* Patients with clinical stage II to III new breast cancer, all diagnosed by hollow-core needle aspiration biopsy pathological histology prior to treatment and surgically resectable breast cancer with positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH).\n* The presence of at least one measurable lesion according to RECIST 1.1 criteria.\n* Exclusion of distant metastases by abdominal B-ultrasound, chest X-ray and whole-body bone scan prior to neoadjuvant chemotherapy, and for lymph nodes in the enlarged area fine needle aspiration cytology is required to clarify the presence of tumor metastases without a history of remaining malignancies.\n* Expected survival of not less than 12 weeks.\n* No previous treatment, including chemotherapy, radiotherapy, targeted therapy, and biologic therapy. -Exclusion Criteria\n\nExclusion Criteria:\n\n* Female patients of childbearing age who are pregnant, breastfeeding, or unwilling to use effective contraception throughout the trial period.\n* Patients with combined severe cardiac, hepatic, renal, or endocrine system diseases and with expected survival of \\\u003C 2 years for the above diseases.\n* Inability to swallow, intestinal obstruction, the presence of other factors affecting drug administration and absorption or a history of allergy to this drug\n* Karnofsky scale score below 60\n* Patients with metastatic breast cancer or bilateral breast cancer.\n* Patients with inflammatory breast cancer.\n* Those with a left ventricular ejection fraction (LVEF) \\\u003C55% on echocardiography\n* Those who are deemed by the personnel to be otherwise unsuitable for clinical trials.","FEMALE","18 Years","70 Years",{"count":42,"type":43},20,"ESTIMATED","INTERVENTIONAL",[46],"PHASE4","This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.",[49],"Breast Cancer",[49,51,52],"Neoadjuvant","Targeted Therapy","NOT_YET_RECRUITING","2022-01-04",{"date":56,"type":57},"2022-01-05","ACTUAL",{"date":56,"type":43},{"date":60,"type":43},"2027-09-20",{"name":5,"class":6}]