[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633524":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":65,"locations":36,"responsibleParty":71,"collaborators":36,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":36,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":36,"enrollmentInfo":84,"targetDuration":36,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":95,"whyStopped":36,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":36},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15,16,17,18],"Drug: Trastuzumab (Herceptin)","Drug: Pertuzumab","Drug: Combination product: Trastuzumab + Pertuzumab","Drug: Docetaxel or Nab-paclitaxel","Drug: carboplatin","Drug: ADC",{"label":20,"type":10,"description":21,"interventionNames":22},"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.",[13,14,15,16,17,23,24],"Drug: CDK4\u002F6 inhibitor","Drug: Aromatase Inhibitor (AI)",{"label":26,"type":27,"description":28,"interventionNames":29},"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.",[13,14,15,16,17],[31,37,41,45,49,53,57,61],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Trastuzumab (Herceptin)","8 mg\u002Fkg first dose, followed 6 mg\u002Fkg given into the vein (IV; intravenously) every 21 days",[9,20,26],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Pertuzumab","840 mg first dose, followed 420 mg given by IV every 21 days",[9,20,26],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Combination product: Trastuzumab + Pertuzumab","600 mg Pertuzumab, 600 mg Trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days",[9,20,26],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Docetaxel or Nab-paclitaxel","Docetaxe 75mg\u002Fm²\u002F Nab-paclitaxel：260mg\u002Fm²",[9,20,26],{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":36},"carboplatin","AUC6",[9,20,26],{"type":32,"name":54,"description":55,"armGroupLabels":56,"otherNames":36},"CDK4\u002F6 inhibitor","Ribociclib 600mg once daily every 21days\u002F Dalpiciclib 150mg once daily every 21days\u002F Palbociclib 125mg once daily every 21days",[20],{"type":32,"name":58,"description":59,"armGroupLabels":60,"otherNames":36},"Aromatase Inhibitor (AI)","Letrozole 2.5mg once daily\u002F Anastrozole 1mg once daily\u002F Exemestane25mg once daily",[20],{"type":32,"name":62,"description":63,"armGroupLabels":64,"otherNames":36},"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",[9],[66],{"name":67,"role":68,"phone":69,"phoneExt":36,"email":70},"Xu Liang","CONTACT","010-8819 6406","liangxu15@outlook.com",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","xuliang","professor","100633524","phase-2-optimization-of-dynamic-neoadjuvant-therapy-strategies-for-her2-positive-breast-cancer-based-on-her2-petct-molecular-imaging-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":85,"type":86},156,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92],"Breast Cancer",[94],"breast cancer","NOT_YET_RECRUITING","2026-04-14",{"date":98,"type":99},"2026-04-17","ACTUAL",{"date":101,"type":86},"2026-05-01",{"date":103,"type":86},"2029-12-31",{"name":5,"class":6}]