[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-positive-her2-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-positive-her2-positive-breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100654095","phase-2-culmerciclib-combined-with-letrozole-and-dual-her2-blockade-as-neoadjuvant-therapy-for-hrher2-breast-cancer-100654095",false,"NCT07795424","Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+\u002FHER2+ Breast Cancer","A Single-Arm, Prospective, Multicenter Phase II Study of Culmerciclib Plus Letrozole and Trastuzumab (TQB211)\u002FPertuzumab (TQB2440) as Neoadjuvant Therapy in Patients With HR-Positive\u002FHER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed HR-positive (ER \\>=50%, PR \\>=10%) and HER2-positive (IHC 3+ or ISH+) breast cancer;\n* Clinical stage II-III (AJCC 8th edition);\n* Treatment-naive: no prior systemic anti-tumor therapy for breast cancer;\n* ECOG performance status 0-1;\n* Adequate organ function;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Distant metastasis (stage IV disease);\n* Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for the current breast cancer;\n* Severe cardiac dysfunction or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal;\n* Pregnancy or lactation;\n* Any other condition that, in the investigator's opinion, makes the patient unsuitable for the study.","FEMALE","18 Years","70 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm, prospective, multicenter, phase II clinical study evaluating the efficacy and safety of a chemotherapy-free neoadjuvant regimen in patients with HR-positive\u002FHER2-positive (HR+\u002FHER2+) early or locally advanced breast cancer.\n\nApproximately 33 treatment-naive patients with stage II-III (AJCC 8th edition) HR+\u002FHER2+ breast cancer will receive 5 cycles of neoadjuvant treatment with culmerciclib (a CDK4\u002F6 inhibitor) plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440), followed by definitive breast surgery.\n\nThe primary endpoint is breast pathological complete response rate (bpCR, ypT0\u002Fis ypN0). Secondary endpoints include objective response rate (ORR), residual cancer burden (RCB), Ki67 change rate, patient-reported outcomes, and safety assessed per CTCAE v5.0.",[27,28],"Breast Cancer","HR Positive, HER2 Positive Breast Cancer",[30],"Neoadjuvant Therapy CDK4\u002F6 Inhibitor Culmerciclib Letrozole Trastuzumab Pertuzumab Chemotherapy-free","NOT_YET_RECRUITING","2026-08-26",{"date":34,"type":35},"2026-08-31","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2028-06-30",{"name":41,"class":42},"Shengjing Hospital","OTHER"]