[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572435":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":11,"responsibleParty":30,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Guangzhou Women and Children's Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"T-DXd combined with immune checkpoint inhibitor","EXPERIMENTAL",null,[13],"Drug: T-DXd combined with immune checkpoint inhibitor",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Subjects who are eligible for the study and have signed informed consent will receive T-DXd in combination with an immune checkpoint inhibitor. The specific dosing regimen is as follows: T-DXd (5.4 mg\u002Fkg i.v. q3w) every 3 weeks for a total of 8 courses. Teraplizumab (240 mg\u002Fkg i.v. q3w), 1 course every 3 weeks for a total of 8 courses.",[9],[20],{"name":21,"affiliation":22,"role":23},"Li Jie director, Doctor","Women and Children's Medical Center of Guangzhou Medical University","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Wang Hui jin, doctor","CONTACT","+8618312660334","wanghuijin_doc@163.com",{"type":23,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Huijin Wang","Director of Thyroid and Breast Disease Center","100572435","phase-2-a-study-evaluating-the-efficacy-and-safety-of-de-trastuzumab-t-dxd-in-combination-with-immunotherapy-for-the-neoadjuvant-treatment-of-hr-positive-her2-low-expressing-chinese-patients-with-early-stage-breast-cancer-100572435",false,"NCT06733233","A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer","A Multicenter, Prospective Phase II Single-arm Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with T-DXd in Combination with an Immune Checkpoint Inhibitor in HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer","Inclusion Criteria:\n\n1. Adults between the ages of 18 and 70 at the time of signing the informed consent form.\n2. An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n3. Previously untreated, operable invasive breast cancer measuring greater than 2.0 centimeters (cT2) with positive clinical lymph nodes (cN1\u002FcN2); or clinically staged T3-T4, clinically lymph node-negative (N0) or clinically lymph node-positive (cN1\u002FcN2) without distal metastases.\n4. Tumors with low levels of HER2 expression by immunohistochemistry (IHC), defined as IHC 1+ or IHC 2+ and FISH negative.\n5. Tumor documented as HR-positive (ER and\u002For PgR-positive \\[ER or PgR ≥1%\\] by local assessment according to ASCO-CAP guidelines).\n6. Patients who agree to undergo surgical treatment for breast cancer when they meet surgical criteria after neoadjuvant therapy.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer and bilateral breast cancer\n2. Previous history of invasive breast cancer.\n3. Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)\n4. Other malignant tumors within 5 years, excluding cured carcinoma in situ of the cervix and non-melanoma skin cancers.","FEMALE","18 Years","70 Years",{"count":44,"type":45},23,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary intermediate- to high-risk HR-positive, HER2-overexpressing early-stage breast cancer.",[51,52],"Breast Cancer, Estrogen Receptor-Positive","HER2 Low Breast Cancer",[54,55,56,57],"Breast cancer","immunotherapy","DS8201","Neoadjuvant","NOT_YET_RECRUITING","2024-12-10",{"date":61,"type":62},"2024-12-13","ACTUAL",{"date":64,"type":45},"2025-01-01",{"date":66,"type":45},"2029-01-01",{"name":5,"class":6}]