[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chuan Wang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100602874","phase-2-shr-a1811-for-her2-positive-breast-cancer-with-suboptimal-neoadjuvant-response-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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Early Breast Cancer","HER2 + Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer",[32,33,34,35],"neoadjuvant therapy","antibody drug conjugate","SHR-A1811","suboptimal response","NOT_YET_RECRUITING","2025-08-20",{"date":39,"type":40},"2025-08-26","ACTUAL",{"date":42,"type":21},"2025-10",{"date":44,"type":21},"2030-10",{"name":46,"class":47},"Chuan Wang","OTHER",""]