[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633524":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":48,"overallOfficials":17,"centralContacts":82,"locations":17,"responsibleParty":88,"collaborators":17,"id":92,"slug":17,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":17,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":17,"enrollmentInfo":100,"targetDuration":17,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":111,"whyStopped":17,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":17},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"rate of pathologic complete response (pCR)","Proportion of participants who have no evidence by H\\&E staining of residual invasive disease","Up to 6 months after treatment start",[14],{"measure":15,"description":16,"timeFrame":12},"SUVmax change on HER2-PET","The change in SUVmax value of HER2-PET after 2 cycles of treatment compared to the baseline level",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NON_RANDOMIZED","CROSSOVER","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","This is a prospective, two-arm, interventional study. Eligible patients with early-stage HER2-positive breast cancer are enrolled into Arm A (TCbHP: trastuzumab, pertuzumab, docetaxel\u002Fnab-paclitaxel, and carboplatin) or Arm B (trastuzumab, pertuzumab, CDK4\u002F6 inhibitor, and aromatase inhibitor), based on molecular subtype and patient preference. Patients in the control group (ArmC) will receive standard TCbHP therapy without intervention. All patients will undergo HER2-PET\u002FCT imaging at baseline and after two cycles of treatment. Metabolic response, defined as a ≥40% reduction in SUVmax of target lesions, guides subsequent therapy: responders continue the initial regimen, while non-responders switch to an alternative strategy (ADC in Arm A or TCbHP in Arm B). The primary endpoint is the total pathological complete response (tpCR) rate in Arm A and ArmB.",[26,37,43],{"label":27,"type":28,"description":29,"interventionNames":30},"Cohort A","EXPERIMENTAL","The initial treatment regimen is the TCbHP (Trastuzumab + Pertuzumab + Docetaxel\u002FNab-paclitaxel + Carboplatin). After two cycles, patients assessed as metabolic responders by HER2 PET continue the TCbHP regimen for a total of six cycles, followed by surgery. Metabolic non-responders are switched to either SHR-A1811 (4.8 mg intravenously every 21 days) or Trastuzumab Deruxtecan (T-DXd, 5.4 mg\u002Fkg intravenously every 21 days) for four cycles of intensified therapy.",[31,32,33,34,35,36],"Drug: Trastuzumab (Herceptin)","Drug: Pertuzumab","Drug: Combination product: Trastuzumab + Pertuzumab","Drug: Docetaxel or Nab-paclitaxel","Drug: carboplatin","Drug: ADC",{"label":38,"type":28,"description":39,"interventionNames":40},"Cohort B","The initial treatment regimen consists of trastuzumab + pertuzumab + CDK4\u002F6 inhibitor + aromatase inhibitor (AI) ± GnRHa. After two cycles, patients assessed as metabolic responders by HER2 PET continue the original regimen for a total of six cycles of dual HER2-antibody (HP), followed by surgery. Non-responders are switched to the TCbHP regimen for another six cycles, followed by surgery.",[31,32,33,34,35,41,42],"Drug: CDK4\u002F6 inhibitor","Drug: Aromatase Inhibitor (AI)",{"label":44,"type":45,"description":46,"interventionNames":47},"Cohort C","ACTIVE_COMPARATOR","Patients who will receive surgery after completion of standard TCbHP regimen were be consecutively enrolled. Neither HER2-PET evaluation nor regimen adjustment based on the evaluation results was allowed.",[31,32,33,34,35],[49,54,58,62,66,70,74,78],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":17},"DRUG","Trastuzumab (Herceptin)","8 mg\u002Fkg first dose, followed 6 mg\u002Fkg given into the vein (IV; intravenously) every 21 days",[27,38,44],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":17},"Pertuzumab","840 mg first dose, followed 420 mg given by IV every 21 days",[27,38,44],{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":17},"Combination product: Trastuzumab + Pertuzumab","600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days",[27,38,44],{"type":50,"name":63,"description":64,"armGroupLabels":65,"otherNames":17},"Docetaxel or Nab-paclitaxel","Docetaxe 75mg\u002Fm²\u002F Nab-paclitaxel：260mg\u002Fm²",[27,38,44],{"type":50,"name":67,"description":68,"armGroupLabels":69,"otherNames":17},"carboplatin","AUC6",[27,38,44],{"type":50,"name":71,"description":72,"armGroupLabels":73,"otherNames":17},"CDK4\u002F6 inhibitor","Ribociclib 600mg once daily every 21days\u002F Dalpiciclib 150mg once daily every 21days\u002F Palbociclib 125mg once daily every 21days",[38],{"type":50,"name":75,"description":76,"armGroupLabels":77,"otherNames":17},"Aromatase Inhibitor (AI)","Letrozole 2.5mg once daily\u002F Anastrozole 1mg once daily\u002F Exemestane25mg once daily",[38],{"type":50,"name":79,"description":80,"armGroupLabels":81,"otherNames":17},"ADC","T-Dxd: 5.4mg\u002Fkg given into the vein (IV; intravenously) every 21 days SHR-A1811: 4.8mg\u002Fkg given into the vein (IV; intravenously) every 21 days",[27],[83],{"name":84,"role":85,"phone":86,"phoneExt":17,"email":87},"Xu Liang","CONTACT","010-8819 6406","liangxu15@outlook.com",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","xuliang","professor","100633524",false,"NCT07527806","Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET\u002FCT Molecular Imaging","A Prospective, Double-Arm Study on the Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET\u002FCT Molecular Imaging","Inclusion Criteria:\n\n* Voluntary participation with written informed consent obtained prior to any study-related procedures\n* Age ≥ 18 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Histologically confirmed HER2-positive (IHC 3+, or IHC 2+ with ISH amplification) stage I-III (cT1-3\u002FcN0-2) breast cancer\n* Tumor diameter ≥ 1.5 cm assessed by imaging, with at least one PET-evaluable lesion present\n* Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status. For Arm B, ER expression ≥ 10% and must be strongly positive.\n* Adequate bone marrow, liver, and renal function: WBC \\> 3.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, Hb ≥ 10.0 g\u002FdL; total bilirubin ≤ ULN (excluding Gilbert's syndrome), ALP ≤ 2.5 × ULN, AST\u002FALT ≤ 1.5 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n* Patients who participate in the trial have good compliance and are willing to comply with the follow-up visit.\n\nExclusion Criteria:\n\n* Prior treatment with any chemotherapy, anti-HER2 therapy, radiotherapy, or endocrine therapy, etc\n* Locally advanced (cT4\u002FcN3) or bilateral breast cancer\n* Patients with known allergies to any active ingredients or excipients of investigational medicinal product\n* Other malignancy diagnosed within 5 years prior to enrollment, excluding cervical carcinoma in situ and cured melanoma skin cancer\n* Left ventricular ejection fraction (LVEF) \\\u003C 55%\n* Uncontrolled hypertension (systolic \\> 150 mm Hg and\u002For diastolic \\> 100 mm Hg)\n* Severely cardiovascular disease\n* Current known infection with HIV, hepatitis B virus, or hepatitis C virus\n* Patients with pulmonary disease requiring continuous oxygen therapy, previous history of bleeding diathesis or patient is currently receiving anti-coagulant therapy, or immunosuppressive agent\n* Major surgical procedure or significant traumatic injury\n* Patient has other concurrent severe and\u002For uncontrolled medical conditions.\n* Concurrent participation in other interventional clinical trial\n* History of receiving any investigational treatment within 28 days prior to randomization\n* Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol\n* Inability to lie flat or presence of psychiatric disorders such as claustrophobia","ALL","18 Years",{"count":101,"type":102},156,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This study evaluates HER2-PET\u002FCT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.",[108],"Breast Cancer",[110],"breast cancer","NOT_YET_RECRUITING","2026-04-14",{"date":114,"type":115},"2026-04-17","ACTUAL",{"date":117,"type":102},"2026-05-01",{"date":119,"type":102},"2029-12-31",{"name":5,"class":6}]