[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588232":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":54,"collaborators":23,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":23,"enrollmentInfo":66,"targetDuration":23,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A Omission of Surgery","EXPERIMENTAL","Arm A will evaluate the omission of surgery in unifocal T1-2 clinically N0, M0 patients who will demonstrate maximum response after neoadjuvant systemic treatment (i.e. whole breast irradiation only).",[13],"Other: Omission of local therapies",{"label":15,"type":10,"description":16,"interventionNames":17},"B Omission of Radiotherapy","Arm B will evaluate the omission of radiotherapy in unifocal T1-2, N1, M0 patients with complete pathological response proved by standard conservative surgical treatment (i.e. conservative surgery only and surgical staging of axilla).",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Omission of local therapies","Omission of surgery (arm A) or radiotherapy (arm B) in those patients who have had the maximum response by neoadjuvant treatments. Maximum responders are those patients with no evidence of residual disease after neoadjuvant treatment at imaging -including mammography, US evaluation and contrast imaging procedures (MRI and\u002For CEM)-, confirmed by VABB on marked site of ascertained lesion.\n\nThis study is open to all patients with T1-2, N0-1, M0 HER2-positive or triple negative breast cancer, treated with neoadjuvant systemic treatment, irrespective of treatments delivered.",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Massimiliano Gennaro, MD","Fondazione IRCCS Istituto Nazionale Tumori Milan","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+390223903246","massimiliano.gennaro@istitutotumori.mi.it",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Kiara Muca","+390223903908","kiara.muca@istitutotumori.mi.it",[39],{"facility":40,"status":41,"city":42,"state":23,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Fondazione IRCCS Istituto Nazionale Tumori Milano","RECRUITING","Milan","20133","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],12.59836,42.78235,{"lat":50,"lon":49},[53],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},{"type":55,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100588232","phase-2-omission-of-local-therapies-in-women-patients-with-her2-positive-or-triple-negative-breast-cancer-100588232",false,"NCT06938724","Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer","Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer: A Two Arm, Phase 2, Non-inferiority Trial for Surveillance in Maximum Responders to Neoadjuvant Systemic Therapy","OLT","Inclusion Criteria:\n\n* Women ≥ 18y.\n* Initial diagnosis of unifocal HER2-positive (regardless of HR status) or Triple-negative (HR positivity lower than 10% is allowed) T1-2, N0-1, M0 breast cancer.\n* Treated with neoadjuvant systemic treatment according to the center recommendations.\n* Maximum responders and\u002For complete pathological response proved by surgery.\n* Scheduled for breast conservation.\n* Giving specific informed consent.\n\nExclusion Criteria:\n\n* One of the inclusion criteria missed.\n* Residual ductal carcinoma in situ (DCIS) at VABB and\u002For surgery.\n* Bilateral synchronous breast cancer.\n* Previous malignancy within 5 years.\n* BRCA1-2, PALB2 or p53 proven mutation carrier (VUS are exclusion criteria as well).\n* Patients unable to perform regular follow up.","FEMALE","18 Years",{"count":67,"type":68},152,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.",[74],"Breast Neoplasm Malignant Female",[76,20,77,78],"Surveillance for breast cancer relapses","Omission of surgery","Omission of radiotherapy","2025-09-12",{"date":81,"type":82},"2025-09-15","ACTUAL",{"date":84,"type":82},"2025-07-25",{"date":86,"type":68},"2035-07-25",{"name":5,"class":6},1]