[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604764":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":39,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":25,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":25,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5 years of standard endocrine therapy","ACTIVE_COMPARATOR","The control group receives 5 years of standard endocrine therapy:\n\nPremenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 5 years) or Toremifene (60 mg, orally, once daily, for 5 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 5 years) or Anastrozole (1 mg, orally, once daily, for 5 years) or Exemestane (25 mg, orally, once daily, for 5 years); A sequential regimen of 2-3 years of Tamoxifen or Toremifene followed by 3-2 years of Letrozole, Anastrozole, or Exemestane is acceptable.\n\nOvarian function suppression is permitted for premenopausal patients. CDK4\u002F6 inhibitors are not allowed during the treatment course",[13],"Drug: Endocrine Therapy of Physician's Choice",{"label":15,"type":16,"description":17,"interventionNames":18},"2-3 years of de-escalated endocrine therapy","EXPERIMENTAL","The experimental group receives 2-3 years of endocrine therapy:\n\nPremenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 2-3 years) or Toremifene (60 mg, orally, once daily, for 2-3 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 2-3 years) or Anastrozole (1 mg, orally, once daily, for 2-3 years) or Exemestane (25 mg, orally, once daily, for 2-3 years).\n\nOvarian function suppression is permitted for premenopausal patients. CDK4\u002F6 inhibitors are not allowed during the treatment course.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Endocrine Therapy of Physician's Choice","This study employs a 2-3 year de-escalated endocrine therapy regimen in the experimental group, which distinguishes it from other escalation therapy studies.",[15,9],null,[27],{"facility":28,"status":25,"city":29,"state":25,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":25},"270 Dongan Road, Fudan University Shanghai Cancer Center","Shanghai","200032","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.45806,31.22222,{"lat":37,"lon":36},{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Zhimin Shao","Professor","100604764","phase-3-de-escalation-therapy-in-stage-i-er-positive-breast-cancer-a-non-inferiority-trial-100604764",false,"NCT07153757","De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial","A Prospective, Randomized, Open-label, Non-inferiority, Phase III Study Evaluating the Efficacy and Safety of 2 to 3 Years of Adjuvant Endocrine De-escalation Therapy for ER-positive\u002FHER2-negative Stage I Breast Cancer","DESCENT","Inclusion Criteria:\n\n* Females aged 18 years or older;\n* Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0);\n* Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%;\n* Presence of at least one of the following potential low-risk factors:\n\n  1）Tumor size ≤1 cm, 2）21-gene recurrence score \\\u003C11, 3）Fudan digital pathological subtype classified as SNF1, 4）Age ≥65 years;\n* ECOG performance status of 0 or 1;\n* Patients with bilateral synchronous invasive lesions are eligible if both lesions are ER-positive, HER2-negative, and meet the tumor size criteria;\n* Normal major organ function, meeting the following criteria:\n\n  1. Hematological: HB ≥90 g\u002FL (no transfusion within 14 days), ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL;\n  2. Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n* Participants voluntarily enroll, sign informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Primary tumor size \\>2 cm in maximum diameter and\u002For axillary lymph node positivity;\n* Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;\n* Prior adjuvant chemotherapy;\n* Use of CDK4\u002F6 inhibitors in the adjuvant setting;\n* History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);\n* Metastasis at any site;\n* Pregnancy, lactation, or women of childbearing potential unable to use effective contraception;\n* Concurrent participation in other clinical trials;\n* Severe cardiac, pulmonary, hepatic, or renal dysfunction; LVEF \\\u003C50% (by echocardiography); severe cardio-cerebrovascular diseases within 6 months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \\>150\u002F90 mmHg, myocardial infarction, or stroke); poorly controlled diabetes; severe hypertension;\n* Severe or uncontrolled infections;\n* History of drug abuse or psychiatric disorders;\n* Patients deemed unsuitable for the study by the investigator.","ALL","18 Years",{"count":54,"type":55},2934,"ESTIMATED","INTERVENTIONAL",[58],"PHASE3","This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. The aim is to evaluate the safety and efficacy of 2-3 years of de-escalated endocrine therapy in patients with T1N0M0 potentially low-risk breast cancer, respectively.",[61],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","NOT_YET_RECRUITING","2025-09-03",{"date":65,"type":66},"2025-09-04","ACTUAL",{"date":68,"type":55},"2025-09-01",{"date":70,"type":55},"2033-09-01",{"name":5,"class":6},1]