[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554165":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":10,"responsibleParty":24,"collaborators":10,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":30,"acronym":10,"eligibilityCriteria":31,"healthyVolunteers":28,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":10,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":10},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Pyrotinib",null,[12],"Drug: Pyrotinib",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"DRUG","Administration method: Pyrrolitinib standard dose: 400 mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 21 days per cycle. The dosage can be determined by the doctor according to the actual situation Make adjustments. Other medications: The doctor selects the medication plan based on the actual situation.",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"xuejing liu","CONTACT","19502151516","lxj8109@126.com",{"type":25,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100554165","the-real-world-study-of-pyrotinib-in-the-treatment-of-advanced-breast-cancer-with-her2-positive-100554165",false,"NCT06495541","The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive);\n3. There is a traceable medical history record during the treatment period;\n4. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up.\n\nExclusion Criteria:\n\n1. Failure to sign informed consent form;\n2. Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer;\n3. Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors;\n4. Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception;\n5. Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.","FEMALE","18 Years",{"count":35,"type":36},500,"ESTIMATED","INTERVENTIONAL",[39],"NA","Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients\n\nResearch purpose:\n\nMain research objectives:\n\nTo observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive advanced first-line breast cancer.\n\nSecondary research objectives:\n\n1. Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)\n2. Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment\n3. To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2 positive breast cancer\n\nResearch endpoint:\n\nMain research endpoint:\n\nProgression free survival (rwPFS)\n\nSecondary study endpoint:\n\nEfficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until treatment failure Time to Flight (TTF), Total Survival (OS), Security",[42,43,9],"Breast Cancer","RWS","NOT_YET_RECRUITING","2026-03-18",{"date":47,"type":48},"2026-03-20","ACTUAL",{"date":50,"type":36},"2026-04-01",{"date":52,"type":36},"2028-07-30",{"name":5,"class":6}]