[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637795":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":40,"locations":46,"responsibleParty":61,"collaborators":11,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib","EXPERIMENTAL",null,[13,14,15,16,17],"Drug: Dalpiciclib","Drug: Trastuzumab (Herceptin)","Drug: Pertuzumab","Drug: Pyrotinib","Drug: Endocrine Therapy 1",[19,24,28,32,36],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Dalpiciclib","Oral CDK4\u002F6 inhibitor (dose modification permitted for toxicity management)",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Trastuzumab (Herceptin)","Subcutaneous, 600mg Q3W; IV: 8mg\u002Fkg (loading) → 6mg\u002Fkg Q3W",[9],{"type":20,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Pertuzumab","IV: 840mg (loading) → 420mg Q3W",[9],{"type":20,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Pyrotinib","240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea",[9],{"type":20,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Endocrine Therapy 1","Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)",[9],[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Chen Doctor Chen, PhD \u002F Doctorate","CONTACT","02087341812","chenmt@sysucc.org.cn",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":11},"Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District","RECRUITING","Guangdong","GUANGZHOU","510060","China","CN",{"type":56,"coordinates":57},"Point",[58,59],129.33635,42.76832,{"lat":59,"lon":58},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jia-Jia Huang","Department of Medical Oncology Professor, Principal Investigator, Chief Physician","100637795","phase-2-dalpiciclib-anti-her2-therapy-and-endocrine-therapy-for-hormone-receptor-positive-her2-positive-metastatic-breast-cancer-100637795",false,"NCT07610720","Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer","Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.\n2. Hormone receptor (HR)-positive and HER2-positive.\n3. Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.\n4. ECOG Performance Status: 0-1.\n\nExclusion Criteria:\n\n1. Symptomatic active brain metastases or extensive leptomeningeal metastases.\n2. History of Grade 3 or 4 allergic reaction related to the study drugs.\n3. Currently receiving other anti-tumor therapies.","FEMALE","18 Years","75 Years",{"count":76,"type":77},57,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.",[83,84],"Advanced\u002FMetastatic Breast Cancer","HER2-Positive Metastatic Breast Cancer",[21,86],"Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy","2026-05-20",{"date":89,"type":90},"2026-05-28","ACTUAL",{"date":92,"type":77},"2026-06-01",{"date":94,"type":77},"2029-11-01",{"name":5,"class":6},1]