[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637806":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":25,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":25,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":25},{"fullName":5,"class":6},"Shanghai Henlius Biotech","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HLX319","EXPERIMENTAL","The regimen in the experimental group is HLX319 in combination with docetaxel and carboplatin.",[13],"Drug: HLX319",{"label":15,"type":16,"description":17,"interventionNames":18},"EU-Phesgo®","ACTIVE_COMPARATOR","The regimen in the control group is EU-Phesgo® in combination with docetaxel and carboplatin.",[19],"Drug: EU-Phesgo®",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"EU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Qi Jin","CONTACT","86 159 5516 0489","Qi_jin@henlius.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100637806","phase-1-a-study-to-evaluate-the-pharmacokinetics-efficacy-and-safety-of-hlx319-vs-eu-phesgo-in-the-neoadjuvant-therapy-of-her2-positive-early-or-locally-advanced-breast-cancer-100637806",false,"NCT07601620","A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Voluntary participation in the clinical study and signed the Informed Consent Form (ICF).\n* Male or female aged ≥ 18 years old at the time of signing the ICF;\n* Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory.\n* Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.\n* Left ventricular ejection fraction (LVEF) at baseline ≥ 55%.\n* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n* Adequate major organ functions.\n* Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose.\n\nExclusion Criteria:\n\n* Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer.\n* History of other malignancy within 5 years.\n* Prior systemic therapy for breast cancer treatment or radiotherapy.\n* Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast.\n* Patients who have undergone excision biopsy of the primary tumor and\u002For axillary lymph nodes or lymph node dissection.\n* Have severe heart disease or medical conditions.\n* Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis.\n* Human Immunodeficiency Virus (HIV) infection, HIV antibody positive.\n* Daily use of corticosteroid treatment is required.\n* Sensitivity to any study medications or any of its ingredients or excipients.\n* Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose.\n* Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period.\n* Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan.\n* Any other conditions which are inappropriate for the study in the opinion of the investigator.","ALL","18 Years",{"count":47,"type":48},258,"ESTIMATED","INTERVENTIONAL",[51],"PHASE1","This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .",[54],"HER2 + Breast Cancer","NOT_YET_RECRUITING","2026-05-15",{"date":58,"type":59},"2026-05-22","ACTUAL",{"date":61,"type":48},"2026-07-03",{"date":63,"type":48},"2027-07-22",{"name":5,"class":6}]