[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654095":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":52,"overallOfficials":34,"centralContacts":70,"locations":76,"responsibleParty":95,"collaborators":34,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":34,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":34,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":121,"whyStopped":34,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Shengjing Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Breast Pathological Complete Response Rate (bpCR)","Proportion of patients achieving ypT0\u002Fis ypN0 (no invasive cancer in the breast and no involved axillary lymph nodes), assessed by postoperative pathology.","At time of surgery, after completion of 5 cycles of neoadjuvant therapy (approximately 5 months from treatment start)",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate (ORR)","Proportion of patients achieving complete response (CR) or partial response (PR) assessed by imaging according to RECIST 1.1.","At end of neoadjuvant treatment (approximately 5 months from treatment start)",{"measure":19,"description":20,"timeFrame":21},"Residual Cancer Burden (RCB)","Residual cancer burden index and class (RCB-0, I, II, III) assessed by postoperative pathology.","At time of surgery (approximately 5 months from treatment start)",{"measure":23,"description":24,"timeFrame":25},"Ki67 Change Rate","Change in Ki67 proliferation index from baseline (pre-treatment biopsy) to surgery.","From baseline to surgery (approximately 5 months)",{"measure":27,"description":28,"timeFrame":29},"Patient-Reported Outcomes (PRO)","Patient-reported quality of life and symptom measures collected during treatment.","From baseline through end of treatment (approximately 5 months)",{"measure":31,"description":32,"timeFrame":33},"Incidence and Severity of Adverse Events","Number and severity of adverse events graded according to CTCAE v5.0.","From first dose through 30 days after surgery (approximately 6 months)",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NA","SINGLE_GROUP","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","HR-positive\u002FHER2-positive breast cancer accounts for approximately 10% of all breast cancers and shows lower pathological complete response rates to neoadjuvant therapy compared with the HR-negative\u002FHER2-positive subtype. Crosstalk between HER2 and ER signaling pathways contributes to resistance to endocrine and anti-HER2 therapy. Preclinical evidence suggests that CDK4\u002F6 inhibitors synergize with anti-HER2 therapy and may restore tumor sensitivity to HER2 blockade.\n\nEligible patients receive:\n\n* culmerciclib 180 mg orally once daily, in 28-day cycles, for 5 cycles;\n* Letrozole 2.5 mg orally once daily, in 28-day cycles, for 5 cycles;\n* Trastuzumab (TQB211) 8 mg\u002Fkg loading dose followed by 6 mg\u002Fkg intravenously every 3 weeks, for 6 doses;\n* Pertuzumab (TQB2440) 840 mg loading dose followed by 420 mg intravenously every 3 weeks, for 6 doses.\n\nTumor response is assessed by imaging (ultrasound, mammography, and MRI) according to RECIST 1.1. After completion of 5 cycles of neoadjuvant treatment, patients undergo definitive breast cancer surgery, and postoperative pathology is evaluated for bpCR and RCB. Adverse events are assessed per CTCAE v5.0. Exploratory analyses will investigate correlations between biomarkers and treatment response.",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Culmerciclib + Letrozole + TQB211 + TQB2440","EXPERIMENTAL","Patients receive Culmerciclib plus letrozole, trastuzumab (TQB211) and pertuzumab (TQB2440) as neoadjuvant therapy for 5 cycles, followed by definitive breast cancer surgery.",[48,49,50,51],"Drug: Culmerciclib","Drug: Letrozole","Drug: Trastuzumab (TQB211)","Drug: Pertuzumab (TQB2440)",[53,58,62,66],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":34},"DRUG","Culmerciclib","180 mg orally once daily, in 28-day cycles, for a total of 5 cycles.",[44],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":34},"Letrozole","2.5 mg orally once daily, in 28-day cycles, for a total of 5 cycles.",[44],{"type":54,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"Trastuzumab (TQB211)","8 mg\u002Fkg intravenous loading dose, followed by 6 mg\u002Fkg intravenously every 3 weeks, for a total of 6 doses.",[44],{"type":54,"name":67,"description":68,"armGroupLabels":69,"otherNames":34},"Pertuzumab (TQB2440)","840 mg intravenous loading dose, followed by 420 mg intravenously every 3 weeks, for a total of 6 doses",[44],[71],{"name":72,"role":73,"phone":74,"phoneExt":34,"email":75},"Mingda Zhao","CONTACT","+86-18509866694","zhaomingda2021@163.com",[77],{"facility":78,"status":34,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Liaoning Cancer Hospital & Institute","Shenyang","Liaoning","110042","China","CN",{"type":85,"coordinates":86},"Point",[87,88],123.43278,41.79222,{"lat":88,"lon":87},[91],{"name":92,"role":73,"phone":93,"phoneExt":34,"email":94},"Jianyi Li, MD, PhD","+86-13390127607","sjbreast@yeah.net",{"type":96,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":78,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Jianyi Li","Chief Physician","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":110,"type":111},33,"ESTIMATED","INTERVENTIONAL",[114],"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.",[117,118],"Breast Cancer","HR Positive, HER2 Positive Breast Cancer",[120],"Neoadjuvant Therapy CDK4\u002F6 Inhibitor Culmerciclib Letrozole Trastuzumab Pertuzumab Chemotherapy-free","NOT_YET_RECRUITING","2026-08-26",{"date":124,"type":125},"2026-08-31","ACTUAL",{"date":127,"type":111},"2026-09-01",{"date":129,"type":111},"2028-06-30",{"name":5,"class":6},1]