[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657861":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":37,"overallOfficials":23,"centralContacts":42,"locations":48,"responsibleParty":63,"collaborators":23,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":23,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":23,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"pathology complete response rate","After completing neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\\&E)-stained samples from the resected breast cancer tissue and all ipsilateral lymph node specimens shows no residual invasive carcinoma.","From enrollment to the end of treatment at 6 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"bpCR","After completion of neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\\&E)-stained resected breast cancer tissue shows no residual invasive carcinoma.",{"measure":18,"description":19,"timeFrame":12},"ORR","The proportion of subjects achieving complete response (CR) or partial response (PR) during neoadjuvant therapy as the best overall tumor response. Investigators will assess objective response rate (ORR) according to RECIST v1.1.",{"measure":21,"description":22,"timeFrame":12},"RCB","The Residual Cancer Burden (RCB) index and its corresponding RCB class (RCB 0-III) can be calculated from the primary tumor residual size (mm×mm), tumor cellularity (percentage), proportion of in situ carcinoma (percentage), the number of positive lymph nodes, and the greatest dimension of nodal metastasis (mm).",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"HER2-expression-based ADC therapy","EXPERIMENTAL","Based on HER2 immunohistochemistry (IHC) results, HER2 homogeneity\u002Fheterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy.",[36],"Drug: HER2 target therapy",[38],{"type":39,"name":40,"description":34,"armGroupLabels":41,"otherNames":23},"DRUG","HER2 target therapy",[32],[43],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},"yuan peng","CONTACT","86+13671287670","13671287670@163.com",[49],{"facility":5,"status":23,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Beijing","Beijing Municipality","100044","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Shu Wang","chief","100657861","phase-2-adc-based-therapy-accroding-to-her2-heterogeneous-100657861",false,"NCT07844018","ADC Based Therapy Accroding to HER2 Heterogeneous","A Prospective, Single-Arm Study of Anti-HER2 Antibody-Drug Conjugates in HER2-Positive Homogeneous and Heterogeneous Early Breast Cancer as Neoadjuvant Therapy","HER2level","Inclusion Criteria:\n\n* 1.18 years or older and be treatment-naïve breast cancer patients 2.histology confirmed invasive breast carcinoma.HER2-positive defined by our pathology department, defined as IHC 3+ or IHC 2+ with fluorescence\u002Fchromogenic in situ hybridization (FISH\u002FCISH) confirming HER2 gene amplification; 3.Clinically staged as Stage II or III according to AJCC 8th edition 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5.Adequate function of major organs to meet study safety and tolerability requirements 6.Agree to provide tissue biopsies and\u002For blood samples at specified study timepoints (baseline, after cycle 4, after cycle 8, and at surgical resection) for translational research purposes 7.No contraindication to breast-enhanced MRI (no contraindications to breast MRI enhancement 8.Reproductive-age women must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception recognized clinically during the study and for 3 months after the last study drug administration 9.agrees to participate in this study and signs the informed consent form\n\nExclusion Criteria:\n\n* 1.bilateral breast cancer or presenting as recurrent or metastatic disease 2.Within the preceding 5 years prior to written informed consent, any history of malignant neoplasm other than treated cervical in situ carcinoma, skin basal cell carcinoma, or skin squamous cell carcinoma will exclude the subject 3.Within 4 weeks prior to enrollment, subjects who have undergone major surgery unrelated to breast cancer, or who have not fully recovered from such surgery, are excluded; procedures necessary for diagnostic tissue biopsy or peripheral venous catheter placement are allowed 4.History of interstitial lung disease (ILD) or non-infectious pneumonia, or current active ILD\u002Fpneumonia, or radiologic findings during screening that cannot exclude suspected ILD\u002Fpneumonia 5.Presence of significant cardiac disease or other conditions that would make participation unsafe or unsuitable 6.Severe infection within 4 weeks prior to the first dose 7.Known HIV infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV-DNA ≥ 500 IU\u002FmL) or hepatitis C (HCV-RNA above the assay's lower limit) or co-infection with HBV and HCV; autoimmune hepatitis 8.Known hypersensitivity to the study drug or any of its excipients 9.Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women unwilling to use an effective contraception method throughout the study 10.History of definite neurologic or psychiatric disorders including epilepsy or dementia, or known history of psychiatric drug abuse, alcoholism, or substance misuse 11.Any other condition that, in the opinion of the investigator, would make participation unsuitable for this study.","FEMALE","18 Years",{"count":78,"type":79},88,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity\u002Fheterogeneity based on histological analysis. Subjects are not randomized and all will enter the intervention arm; patients with different HER2 homogeneity\u002Fheterogeneity will receive regimens based on anti-HER2 antibody-drug conjugates (ADCs). Recruitment is planned to commence in January 2027 and complete enrollment by December 2028. After obtaining fully informed consent and meeting eligibility criteria, eligible subjects will enter the trial phase and receive a regimen based on anti-HER2 ADCs. Once enrolled, subjects must receive the investigational drug within 72 hours. Each treatment cycle lasts 3 weeks, for a total of 8 cycles, and treatment will continue until the end of the course or until disease progression, unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, study completion, or study termination.",[85],"Breast Cancer (Early Breast Cancer)",[87,88,89],"HER2 positive","ADCs","neoadjuvant therapy","NOT_YET_RECRUITING","2026-09-29",{"date":93,"type":94},"2026-10-02","ACTUAL",{"date":96,"type":79},"2027-01-01",{"date":98,"type":79},"2029-06-30",{"name":5,"class":6},1]