[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472582":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":19,"responsibleParty":31,"collaborators":7,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":7,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":7,"enrollmentInfo":42,"targetDuration":45,"studyType":46,"phases":7,"briefSummary":47,"conditions":48,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},{"fullName":5,"class":6},"National Cancer Center, Japan","OTHER_GOV",null,[9],{"name":10,"affiliation":11,"role":12},"Sho Shiino, MD, PhD","Department of Medical Oncology, National Cancer Cancer Hospital","PRINCIPAL_INVESTIGATOR",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Yuki Kojima, MD, PhD","CONTACT","0335422511","yuukojim@ncc.go.jp",[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":7,"geoPoint":7,"contacts":28},"National Cancer Center Hospital, Japan","RECRUITING","Chuo-ku","Tokyo","104-0045","Japan","JP",[29],{"name":30,"role":16,"phone":7,"phoneExt":7,"email":7},"Shiino Sho, MD,PhD",{"type":32,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100472582","asian-multicenter-prospective-study-in-her2-positive-early-breast-cancer-for-detecting-mrd-by-ctdnaharmony-study-100472582",false,"NCT05433753","Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study","Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy; HARMONY Study","Inclusion Criteria:\n\n1. Age of 20 years or older at the date of registration.\n2. Histological diagnosis of HER2-positive invasive breast carcinoma.\n3. Patients scheduled for neoadjuvant chemotherapy followed by surgery.\n4. Clinical Stage IIA-IIIC.\n5. Known hormone receptor status.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.\n2. Bilateral synchronous breast cancer.\n3. History of breast cancer.\n4. Pregnancy at registration.","ALL","20 Years",{"count":43,"type":44},60,"ESTIMATED","3 Years","OBSERVATIONAL","This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.",[49],"HER2-positive Breast Cancer","2024-03-21",{"date":52,"type":53},"2024-03-25","ACTUAL",{"date":55,"type":53},"2022-05-24",{"date":57,"type":44},"2027-09-30",{"name":5,"class":6},1]