[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602874":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":19,"collaborators":11,"id":23,"slug":11,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":27,"acronym":11,"eligibilityCriteria":28,"healthyVolunteers":24,"sex":29,"minAge":30,"maxAge":31,"enrollmentInfo":32,"targetDuration":11,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":44,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":11},{"fullName":5,"class":6},"Fujian Medical University Union Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1811","EXPERIMENTAL",null,[13],"Drug: SHR-A1811",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Drug: SHR-A1811 4.8mg\u002Fkg",[9],{"type":20,"investigatorFullName":21,"investigatorTitle":22,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Chuan Wang","MD","100602874",false,"NCT07129187","SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response","An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response","Inclusion Criteria:\n\n* 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;\n* 2.Early or locally advanced HER2-positive invasive breast cancer;\n* 3.Known hormone receptor status;\n* 4.ECOG score of 0-1;\n* 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;\n* 6.Organ function levels must meet the following requirements:\n* 7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.\n* 8.The subjects voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer\n* 2\\. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention\n* 3\\. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history\n* 4\\. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)\n* 5\\. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)\n* 6\\. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases\n* 7\\. History of or planned administration of live attenuated vaccines within 28 days\n* 8\\. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis\n* 9\\. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year\n* 10\\. History of allogeneic bone marrow or solid organ transplantation\n* 11\\. Peripheral neuropathy of grade ≥ 2\n* 12\\. Severe heart diseases\n* 13\\. Receipt of systemic immunostimulant therapy within 4 weeks\n* 14\\. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)\n* 15\\. Allergy to study drugs\u002Fexcipients, or history of severe allergic reaction to other monoclonal antibodies\n* 16\\. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial\n* 17\\. History of neurological\u002Fpsychiatric disorders , or history of substance abuse, alcoholism, or drug addiction\n* 18\\. Other circumstances deemed unsuitable for enrollment by the researcher","FEMALE","18 Years","70 Years",{"count":33,"type":34},30,"ESTIMATED","INTERVENTIONAL",[37],"PHASE2","This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.",[40,41,42,43],"Early Breast Cancer","HER2 + Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer",[45,46,9,47],"neoadjuvant therapy","antibody drug conjugate","suboptimal response","NOT_YET_RECRUITING","2025-08-20",{"date":51,"type":52},"2025-08-26","ACTUAL",{"date":54,"type":34},"2025-10",{"date":56,"type":34},"2030-10",{"name":21,"class":6}]