[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615407":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":49,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":20,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":20,"overallStatus":83,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Nagoya City University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment for MRD positive","EXPERIMENTAL","ctDNA-posotive during adjuvant treatment",[13],"Drug: Abemaciclib 150 MG Oral Tablet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Abemaciclib 150 MG Oral Tablet","Adding abemaciclib for 2-year with endcrine treatment",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Ryuta Asada, PhD","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Kazuki Nozawa, MD","CONTACT","+81-52-851-5511","kazuki.nozawa7@gmail.com",[32],{"facility":5,"status":20,"city":33,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Nagoya","Japan","JP",{"type":37,"coordinates":38},"Point",[39,40],136.90641,35.18147,{"lat":40,"lon":39},[43],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":44},"ncu-003@med.nagoya-cu.ac.jp",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Kazuki Nozawa","Principal Investigator",[50,52,54,57,59,61],{"name":51,"class":6},"Tohoku University",{"name":53,"class":6},"Japanese Foundation for Cancer Research",{"name":55,"class":56},"National Cancer Center, Japan","OTHER_GOV",{"name":58,"class":6},"University of Tsukuba",{"name":60,"class":6},"Gifu University Graduate School of Medicine",{"name":62,"class":6},"Aichi Cancer Center","100615407","phase-2-abemaciclib-for-molecular-residual-disease-detected-by-circulating-tumor-dna-in-hrher2--early-breast-cancer-100615407",false,"NCT07292207","Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+\u002FHER2- Early Breast Cancer","Phase 2 Study of Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+\u002FHER2- Early Breast Cancer","ARCHE","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer.\n* ctDNA-positive after completion of definitive local\u002Fsystemic therapy.\n* Definitive breast surgery performed; axillary node status confirmed.\n* HR-positive, HER2-negative disease.\n* Tumor and nodal status meet predefined pathological risk criteria.\n* ECOG PS 0 - 1.\n* No bilateral breast cancer.\n* Adequate recovery from prior therapy and acceptable organ function.\n* No distant metastasis before registration.\n* Appropriate contraception; informed consent obtained.\n\nExclusion Criteria:\n\n* Active second malignancy.\n* Prior CDK4\u002F6 inhibitor use.\n* Recent major surgery or active infection.\n* Uncontrolled hypertension or significant cardiac disease.\n* Recent thromboembolic events.\n* Interstitial lung disease or active pneumonitis.\n* Unrecovered toxicities from prior treatment.\n* Active HIV, HBV, or HCV infection.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The goal of this clinical study is to determine whether monitoring ctDNA and treating patients who become ctDNA-positive with abemaciclib can help prevent the recurrence of hormone receptor-positive, HER2-negative breast cancer after curative surgery and standard therapy. The study will also assess the safety of abemaciclib and the medical problems that may occur during treatment. Participants will receive routine follow-up after surgery, undergo regular blood tests to measure ctDNA, and, if ctDNA becomes positive, receive abemaciclib for a defined treatment period with scheduled clinic visits for examinations and safety assessments. Researchers will evaluate recurrence-free survival, distant recurrence-free survival, adverse events, the time between ctDNA positivity and clinical recurrence, and the rate of ctDNA clearance at the end of abemaciclib therapy.",[81,82],"ctDNA Monitoring","Breast Cancer","NOT_YET_RECRUITING","2025-12-16",{"date":86,"type":87},"2025-12-18","ACTUAL",{"date":89,"type":75},"2026-01-10",{"date":91,"type":75},"2031-08-31",{"name":5,"class":6},1]