[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537698":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":62,"collaborators":19,"id":64,"slug":19,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":19,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Omission of surgical treatment","EXPERIMENTAL","Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy",[13],"Procedure: Omission of surgical treatment",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"PROCEDURE","Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Elisabetta Rossi, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+39-0294372191","ElisabettaMariaCristina.Rossi@ieo.it",[30,46],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Istituto di Candiolo IRCCS","NOT_YET_RECRUITING","Candiolo","Turin","10060","Italy",{"type":38,"coordinates":39},"Point",[40,41],7.59812,44.95858,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":19,"phoneExt":19,"email":19},"Antonio Toesca, MD",{"facility":5,"status":47,"city":48,"state":19,"zip":49,"country":36,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"RECRUITING","Milan","20141",{"type":38,"coordinates":51},[52,53],9.18951,45.46427,{"lat":53,"lon":52},[56,58,61],{"name":22,"role":26,"phone":57,"phoneExt":19,"email":28},"+390294372191",{"name":59,"role":26,"phone":19,"phoneExt":19,"email":60},"Mara Negri","mara.negri@ieo.it",{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":63,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100537698",false,"NCT06281210","Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery","Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment","BETTY-CRASY","Inclusion Criteria:\n\n* age\\> 18 years\n* infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0\n* single lesion\n* neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice\n* conservative surgery proposal\n* M0\n* tumour bed identified by breast markers placed in pre NACT by radiologist\n\nExclusion Criteria:\n\n* Bilateral or multicentric tumour\n* Presence of microcalcifications visualised on mammography\n* Presence of associated DCIS\n* Positive history of previous breast cancer\n* Positive history of medical or psychiatric conditions preventing adherence to the protocol\n* High risk patient","ALL","18 Years",{"count":74,"type":75},77,"ESTIMATED","INTERVENTIONAL",[78],"NA","This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.",[81,82,83,84],"Breast Cancer","Triple Negative Breast Cancer","HER2-positive Breast Cancer","Neoadjuvant Chemotherapy",[86,87,88],"Triple negative breast cancer","HER2-positive breast cancer","neoadjuvant chemotherapy","2024-02-20",{"date":91,"type":92},"2024-02-28","ACTUAL",{"date":94,"type":92},"2023-12-11",{"date":96,"type":75},"2028-12-31",{"name":5,"class":6},2]