[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509325":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":35,"responsibleParty":54,"collaborators":29,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":29,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":29,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":29,"overallStatus":37,"whyStopped":29,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1811","EXPERIMENTAL","SHR-A1811 group",[13],"Drug: SHR-A1811 for injection",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","SHR-A1811 for injection",[9],[11],[21],{"name":22,"affiliation":5,"role":23},"Zhenzhen Liu, PhD","PRINCIPAL_INVESTIGATOR",[25,31],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Zhenzhen Liu, Professor","CONTACT","+86-13603862755",null,"liuzhenzhen73@126.com",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},"Jiujun Zhu, PhD","+86-13676962766","bigapple0601@126.com",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Zhengzhou","Henan","450008","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.64861,34.75778,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":52,"phoneExt":29,"email":53},"Jiao DeChuang","13598004327","jiaodechuang1982@163.com",{"type":23,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Zhenzhen Liu","Professor","100509325","phase-2-a-study-of-shr-a1811-as-neoadjuvant-treatment-for-patients-with-hr-positive-low-her2-expression-breast-cancer-100509325",false,"NCT05911958","A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer","Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer","Inclusion Criteria:\n\n1. Patients aged 18 to 70 years old (inclusive);\n2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;\n3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;\n4. ECOG performance status of 0-1;\n5. Normal organ and bone marrow function;\n6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;\n7. Patients voluntarily joined the study and signed informed consent;\n\nExclusion Criteria:\n\n1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;\n2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;\n3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;\n4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;\n5. Clinically significant pulmonary or cardiovascular disease;\n6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;\n7. Known to be allergic to any study drug or any of its excipients;\n8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n9. Pregnant and lactating women;\n10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.","FEMALE","18 Years","70 Years",{"count":68,"type":69},66,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.",[75],"HER2 Low Breast Carcinoma","2024-10-31",{"date":78,"type":79},"2024-11-04","ACTUAL",{"date":81,"type":79},"2023-07-05",{"date":83,"type":69},"2029-05-31",{"name":5,"class":6},1]