[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543956":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":52,"responsibleParty":69,"collaborators":71,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":23,"enrollmentInfo":85,"targetDuration":23,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative accelerated partial breast re-irradiation","EXPERIMENTAL","Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery",[13,14,15,16],"Radiation: Preoperative accelerated partial breast irradiation","Procedure: Breast conserving surgery","Procedure: Sentinel node procedure","Procedure: Biopsy track removal",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"RADIATION","Preoperative accelerated partial breast irradiation","Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"PROCEDURE","Breast conserving surgery","Patients will be treated with breast conserving surgery.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Sentinel node procedure","Patients will undergo a (repeat) sentinel node procedure.",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Biopsy track removal","The biopsy track will be surgically removed.",[9],[38],{"name":39,"affiliation":5,"role":40},"Astrid Scholten, MD PhD","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Tess Snellen, MD","CONTACT","0205129111","3448","t.snellen@nki.nl",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Lisa van den Hengel","9140","l.vd.hengel@nki.nl",[53],{"facility":5,"status":54,"city":55,"state":23,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Amsterdam","1066CX","Netherlands","NL",{"type":60,"coordinates":61},"Point",[62,63],4.88969,52.37403,{"lat":63,"lon":62},[66],{"name":39,"role":44,"phone":67,"phoneExt":23,"email":68},"+31205129111","a.scholten@nki.nl",{"type":70,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[72,74],{"name":73,"class":6},"Medical Center Haaglanden",{"name":75,"class":6},"Erasmus Medical Center","100543956","preoperative-accelerated-partial-breast-irradiation-in-patients-with-locally-recurrent-or-second-primary-breast-cancer-100543956",false,"NCT06362616","Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer","PAPBI-3","Inclusion Criteria:\n\n* Female patients ≥ 51 years\n* Ipsilateral breast cancer; recurrence or second primary\n* Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)\n* Histologically proven estrogen receptor positive\n* HER2neu negative\n* In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm\n* Grade I or grade II (biopsy)\n* cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)\n* Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)\n* Interval since completion of local treatment of primary tumor \\> 12 months\n* Previous radiotherapy (whole breast or partial) of the ipsilateral breast\n* Repeat breast conserving surgery feasible\n* World Health Organization (WHO) performance ≤ 2\n* Written informed consent\n* The patient is legally competent\n\nExclusion Criteria:\n\n* ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor\n* Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area\n* Distant metastases and\u002For synchronous contralateral invasive or in situ carcinoma\n* Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)\n* ER negative subtype\n* Lymphovascular invasion in biopsy\n* Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months)\n* (Planned) oncoplastic surgery with major tissue displacement\n* Participation in another clinical trial that interferes with the locoregional treatment of this protocol.\n* It is expected that dosimetric constraints cannot be met, such as lung\u002Fheart constraints.\n* Patients with proven BRCA-mutations","FEMALE","51 Years",{"count":86,"type":87},31,"ESTIMATED","INTERVENTIONAL",[90],"NA","This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.",[93],"Breast Cancer",[95,96,97],"Recurrent breast cancer","Preoperative","Partial breast irradiation","2026-01-15",{"date":100,"type":101},"2026-01-20","ACTUAL",{"date":103,"type":101},"2024-04-12",{"date":105,"type":87},"2027-04-11",{"name":5,"class":6},1]