[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639594":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":40,"collaborators":25,"id":44,"slug":25,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":25,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":25,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":25},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A","EXPERIMENTAL","This cohort consists of patients with first-line advanced disease. First-line advanced disease is defined as no prior systemic therapy administered for locally advanced or metastatic disease. For patients who have received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy must be longer than 12 months. First-line patients receive treatment with pyrotinib plus trastuzumab combined with chemotherapy. Upon disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan will be administered.",[13,14],"Drug: Pyrotinib","Drug: Trastuzumab Rezetecan",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort B","This cohort includes patients with second-line advanced breast cancer. Second-line advanced disease is defined as prior receipt of taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or disease recurrence during neoadjuvant\u002Fadjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last cycle of neoadjuvant\u002Fadjuvant chemotherapy and HER2-targeted therapy. Patients in the second-line setting are treated with pyrotinib plus capecitabine. Following disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan is administered.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pyrotinib","Pyrotinib: administered orally once daily at a dose of 400 mg, 320 mg or 240 mg within 30 minutes after breakfast. A continuous administration of 21 days is defined as one treatment cycle. The dosage of pyrotinib will be adjusted by physicians according to the individual clinical conditions. Concomitant chemotherapeutic agents and other supportive care treatments are determined at the investigators' discretion in accordance with clinical practice guidelines and drug instructions.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Trastuzumab Rezetecan","Trastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg\u002Fkg on Day 1 of each cycle, with a 21-day treatment cycle.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"wang shu","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"peng yuan","CONTACT","86+13671287670","13671287670@163.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Shu Wang","director of breast center","100639594",false,"NCT07600164","Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer","Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;\n3. Patients with first-line or second-line advanced disease:\n\n   First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant\u002Fadjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant\u002Fadjuvant chemotherapy and HER2-targeted therapy;\n4. Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;\n5. Traceable medical records available throughout the treatment period.\n\nExclusion Criteria:\n\n1. Failure to sign the informed consent form;\n2. Pregnant or lactating females;\n3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;\n4. Other conditions deemed ineligible for enrollment by the investigator's judgment.","ALL","18 Years",{"count":53,"type":54},500,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration. This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment. It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine). The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes. It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.",[60,61],"HER2 + Breast Cancer","Advanced Breast Cancer",[63,64,65,27],"HER2-positive breast cancer","Advanced breast cancer","pyrotinib","NOT_YET_RECRUITING","2026-05-14",{"date":69,"type":70},"2026-05-20","ACTUAL",{"date":72,"type":54},"2026-06-01",{"date":74,"type":54},"2031-12-30",{"name":5,"class":6}]