[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478083":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy","EXPERIMENTAL","When there is no residual tumor cells on the vacuum-assisted biopsy specimen, breast surgery will be omitted. In the case of clinical N0 AND MRI size ≤ 0.5cm AND lesion-to-background signal enhancement ratio ≤1.6, sentinel lymph node biopsy will be omitted. Otherwise, sentinel lymph node biopsy will be performed. If necessary, axillary lymph node dissection will be performed.",[13],"Procedure: Breast surgery omission",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Breast surgery omission","For patients who are expected to achieve pathologic complete response after neoadjuvant chemotherapy based on MRI findings, vacuum-assisted biopsy will be performed on the main primary lesion marked with a clip. In case of pCR on vacuum-assisted biopsy specimen, breast surgery will be omitted.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Han-Byoel Lee","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+82-2-2072-3447","hblee80@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Hong-Kyu Kim","+82-2-2072-2980","hkkim4592@gmail.com",[35],{"facility":5,"status":36,"city":37,"state":20,"zip":20,"country":38,"countryCode":20,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Seoul","South Korea",{"type":40,"coordinates":41},"Point",[42,43],126.9784,37.566,{"lat":43,"lon":42},[46,47],{"name":23,"role":27,"phone":20,"phoneExt":20,"email":29},{"name":31,"role":27,"phone":20,"phoneExt":20,"email":33},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[51],{"name":52,"class":53},"Ministry of Health & Welfare, Korea","OTHER_GOV","100478083","omission-of-breast-surgery-for-breast-cancer-patients-with-pcr-on-mri-and-vacuum-assisted-biopsy-after-nst-optimist-100478083",false,"NCT05505357","Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)","Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial","OPTIMIST","Inclusion Criteria:\n\n* Sex: female\n* Age: 20 years and older\n* Patients with no clinical\u002Fradiologic distant metastasis\n* Tumor type: Invasive ductal carcinoma\n* Tumor subtype: HER2 positive(including luminal B type, triple negative\n* Extent of disease: initial tumor size ≤ 5cm, cN0-2\n* Patients with measurable tumor size\n* Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6)\n* Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy\n* Patients with informed consent who are competent to make a voluntary decision\n\nExclusion Criteria:\n\n* Multifocal lesion (≥2)\n* Extent of residual microcalcification after neoadjuvant chemotherapy \\> 2cm\n* Bilateral breast cancer or inflammatory breast cancer\n* Contraindication to radiotherapy\n* History of previous contralateral breast cancer\n* Breast cancer patients with distant metastasis\n* Allergic history to MRI contrast\n* Male breast cancer\n* Patients incapable of giving informed consent owing to poor general conditions\n* Patients with BRCA mutation\n* Patients willing to receive breast surgery\n* Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)","FEMALE","20 Years",{"count":65,"type":66},533,"ESTIMATED","INTERVENTIONAL",[69],"NA","A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.",[72],"Breast Cancer Invasive",[74,75,76,77],"neoadjuvant systemic therapy","pathological complete response","vacuum-assisted bIopsy","omission of breast surgery","2024-02-25",{"date":80,"type":81},"2024-02-28","ACTUAL",{"date":83,"type":81},"2022-09-22",{"date":85,"type":66},"2031-06",{"name":5,"class":6},1]