[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537698":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":63,"collaborators":19,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":19,"enrollmentInfo":75,"targetDuration":19,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":48,"whyStopped":19,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[30,47],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Istituto di Candiolo IRCCS","NOT_YET_RECRUITING","Candiolo","Turin","10060","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],7.59812,44.95858,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":19,"phoneExt":19,"email":19},"Antonio Toesca, MD",{"facility":5,"status":48,"city":49,"state":19,"zip":50,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"RECRUITING","Milan","20141",{"type":39,"coordinates":52},[53,54],9.18951,45.46427,{"lat":54,"lon":53},[57,59,62],{"name":22,"role":26,"phone":58,"phoneExt":19,"email":28},"+390294372191",{"name":60,"role":26,"phone":19,"phoneExt":19,"email":61},"Mara Negri","mara.negri@ieo.it",{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":64,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100537698","vabb-after-neoadjuvant-therapy-to-avoid-surgery-pcr-to-avoid-breast-surgery-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":76,"type":77},77,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83,84,85,86],"Breast Cancer","Triple Negative Breast Cancer","HER2-positive Breast Cancer","Neoadjuvant Chemotherapy",[88,89,90],"Triple negative breast cancer","HER2-positive breast cancer","neoadjuvant chemotherapy","2024-02-20",{"date":93,"type":94},"2024-02-28","ACTUAL",{"date":96,"type":94},"2023-12-11",{"date":98,"type":77},"2028-12-31",{"name":5,"class":6},2]