[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593370":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":27,"responsibleParty":48,"collaborators":27,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":27,"enrollmentInfo":61,"targetDuration":27,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":27,"overallStatus":71,"whyStopped":27,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":27},{"fullName":5,"class":6},"Fudan University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Chemotherapy, endocrine therapy, or CDK4\u002F6 inhibitors, administered at the physician's discretion.",[13,14,15],"Drug: Chemotherapy","Drug: CDK4\u002F6 Inhibitor","Drug: Endocrine therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Chemo-free","EXPERIMENTAL","A chemotherapy-sparing approach using CDK4\u002F6 inhibitor combined with aromatase inhibitor (minimum 5-year duration).",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Chemotherapy","Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"CDK4\u002F6 Inhibitor","All patients will receive CDK4\u002F6 inhibitor (abemaciclib\u002Fribociclib\u002Fdalpiciclib\u002Fpalbociclib)",[17,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Endocrine therapy","Endocrine therapy (letrozole\u002Fanastrozole\u002Fexemestane)",[17,9],[37],{"name":38,"affiliation":5,"role":39},"Zhiming Shao","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},"Zhimin Shao, MD, PhD","CONTACT","+86-021-64175590","zhi_ming_shao@163.com",{"name":47,"role":43,"phone":27,"phoneExt":27,"email":45},"Peng Ji",{"type":39,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Zhimin Shao","Director of General Surgery of Fudan Shanghai Cancer Center","100593370","phase-3-chemo-free-in-older-65-node-positive-erher2--breast-cancer-100593370",false,"NCT07005557","Chemo-free in Older (≥65) Node-Positive ER+\u002FHER2- Breast Cancer","Study Evaluating Node-positive, ER+\u002FHER2- In Older (≥65 Years) Breast Cancer Patients for Chemotherapy Exemption: A Randomized, Open-label, Multicenter Phase III Clinical Trial","SENIOR","Inclusion Criteria:\n\n-1. Age: Female patients aged ≥65 years. 2. Disease Status: Histologically confirmed early-stage breast cancer after surgery with ER expression ≥50% AND one of the following:\n\n1. ≥4 positive lymph nodes\n2. 1-3 positive lymph nodes plus at least one of the following high-risk features: i. High-risk multigene assay result ii. Primary tumor size \\>2 cm iii. Histologic grade 3 iv. Lymphovascular invasion (LVI) positive v. Ki-67 \\>20% 3. Treatment Acceptance: Willing to receive adjuvant CDK4\u002F6 inhibitor therapy. 4. Performance Status: ECOG score 0-2. 5. Adequate Organ Function:\n\na) Hematology (within 14 days, no transfusion): i. Hemoglobin (Hb) ≥90 g\u002FL ii. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL iii. Platelets (PLT) ≥100×10⁹\u002FL b) Biochemistry: i. Total bilirubin (TBIL) ≤1.5×ULN ii. ALT\u002FAST ≤3×ULN iii. Serum creatinine (Cr) ≤1×ULN iv. Estimated creatinine clearance (CrCl) \\>50 mL\u002Fmin (Cockcroft-Gault formula) 6. Consent \\& Compliance: Willing to participate, sign informed consent, and comply with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).\n\n  2\\. Bilateral breast cancer. 3. History of other malignancies, except: Cured basal cell carcinoma of the skin； Carcinoma in situ of the cervix 4. Distant metastasis (any site). 5. Any T4 lesion (UICC 1987 TNM staging), including: Skin invasion; Fixed mass adherence; Inflammatory breast cancer 6. Concurrent participation in other clinical trials. 7. Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal), including:\n\n  a) LVEF \\\u003C50% (by echocardiography) b) Major cardiovascular\u002Fcerebrovascular events within 6 months before randomization: i. Unstable angina ii. Chronic heart failure iii. Uncontrolled hypertension (\\>150\u002F90 mmHg) iv. Myocardial infarction or stroke c) Poorly controlled diabetes mellitus d) Severe hypertension 8. Known allergy to taxane-based drugs or their excipients. 9. Severe or uncontrolled infections. 10. History of psychoactive drug abuse (unable to abstain) or psychiatric disorders.\n\n  11\\. Patients deemed ineligible by investigator assessment. 12. Refusal to receive adjuvant CDK4\u002F6 inhibitor therapy.","FEMALE","65 Years",{"count":62,"type":63},1244,"ESTIMATED","INTERVENTIONAL",[66],"PHASE3","This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4\u002F6 inhibitors in endocrine-sensitive luminal-type (ER+\u002FHER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \\>65 years) with lymph node-positive, HR+\u002FHER2- breast cancer.",[69,70],"Breast Cancer","Adjuvant Therapy","NOT_YET_RECRUITING","2025-06-03",{"date":74,"type":75},"2025-06-05","ACTUAL",{"date":77,"type":63},"2025-06-15",{"date":79,"type":63},"2035-05-15",{"name":5,"class":6}]