[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572929":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":54,"centralContacts":59,"locations":66,"responsibleParty":173,"collaborators":175,"id":180,"slug":181,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":182,"sex":188,"minAge":189,"maxAge":53,"enrollmentInfo":190,"targetDuration":53,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":203,"overallStatus":69,"whyStopped":53,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Cancer Research Antwerp","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard treatment arm (SoC; PostOperative RT)","ACTIVE_COMPARATOR","Treatment in this arm consists of:\n\n1. Mastectomy\n2. Immediate or delayed breast reconstruction.\n3. Postoperative radiation therapy, according to the SoC as indicated by international guidelines.\n\n\\[Systemic treatments are not considered as study treatments and will be implemented at the discretion of the treating physician.\\]",[13,14],"Radiation: Postoperative radiotherapy","Procedure: Immediate or delayed breast reconstruction",{"label":16,"type":17,"description":18,"interventionNames":19},"Experimental treatment arm (PreOperative RT)","EXPERIMENTAL","Treatment in this arm consists of:\n\n1. Preoperative radiation therapy (Preop-RT). Preop-RT will be administered according to the same parameters and quality standards as PMRT\u002FWBRT, as indicated by international guidelines.\n2. Mastectomy combined with immediate breast reconstruction, after a 2-6 weeks interval.\n\n\\[Systemic treatments are not considered as study treatments and will be implemented at the discretion of the treating physician.\\]",[20,21],"Radiation: Preoperative radiotherapy","Procedure: Immediate breast reconstruction",[23,32,42,49],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Preoperative radiotherapy","In this study patients assigned to the experimental treatment arm will receive preoperative radiation therapy instead of postoperative radiation therapy (PMRT).\n\nThis preoperative radiation therapy will be administered according to the standard of care (SoC) principles for PMRT and Whole Breast Radiation Therapy (WBRT) as defined by international guidelines.",[16],[29,30,31],"Preop-RT","Neoadjuvant radiation therapy","NART",{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Postoperative radiotherapy","Standard of care (SoC) postoperative radiotherapy, as defined by international guidelines.",[9],[37,38,39,40,41],"Postop-RT","Postmastectomy Radiation Therapy","PMRT","Adjuvant Radiation Therapy","ART",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"PROCEDURE","Immediate breast reconstruction","In the experimental arm of the PRADAIIBE, the participants will undergo immediate breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery. Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach.\n\nAdjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added.",[16],[48],"IBR",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Immediate or delayed breast reconstruction","In the standard arm of the PRADAIIBE, the participants will undergo immediate or delayed breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery (immediate), or at a later time (delayed). Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach. Adjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added.",[9],null,[55],{"name":56,"affiliation":57,"role":58},"Melanie Machiels, MD, PhD","Iridium netwerk","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Tom Quisenaerts, MD","CONTACT","+3234433759","+32","Tom.quisenaerts@zas.be",[67,90,108,123,139,156],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Universitair Ziekenhuis Antwerpen (UZA)","RECRUITING","Edegem","Antwerpen","2650","Belgium","BE",{"type":76,"coordinates":77},"Point",[78,79],4.44504,51.15662,{"lat":79,"lon":78},[82,86,88],{"name":83,"role":62,"phone":84,"phoneExt":64,"email":85},"Isabelle Nietvelt","+32 3 821 30 00","isabelle.nietvelt@uza.be",{"name":87,"role":58,"phone":53,"phoneExt":53,"email":53},"Christophe Van Berckelaer, MD",{"name":89,"role":58,"phone":53,"phoneExt":53,"email":53},"Wiebren Tjalma, MD, PhD",{"facility":91,"status":69,"city":92,"state":71,"zip":93,"country":73,"countryCode":74,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Ziekenhuis aan de stroom","Wilrijk","2610",{"type":76,"coordinates":95},[96,97],4.39513,51.16734,{"lat":97,"lon":96},[100,101,102,104,106],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},{"name":56,"role":58,"phone":53,"phoneExt":53,"email":53},{"name":61,"role":103,"phone":53,"phoneExt":53,"email":53},"SUB_INVESTIGATOR",{"name":105,"role":103,"phone":53,"phoneExt":53,"email":53},"Philip Poortmans, MD, PhD",{"name":107,"role":103,"phone":53,"phoneExt":53,"email":53},"Filip Thiessen, MD, PhD",{"facility":109,"status":110,"city":111,"state":112,"zip":113,"country":73,"countryCode":74,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"AZ Klina","NOT_YET_RECRUITING","Brasschaat","Antwerp","2930",{"type":76,"coordinates":115},[116,117],4.49182,51.2912,{"lat":117,"lon":116},[120],{"name":121,"role":62,"phone":53,"phoneExt":53,"email":122},"Research AZ Klina","datanurse.onco@klina.be",{"facility":124,"status":69,"city":125,"state":125,"zip":126,"country":73,"countryCode":74,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"CHU Namur","Namur","5000",{"type":76,"coordinates":128},[129,130],4.86746,50.4669,{"lat":130,"lon":129},[133,137],{"name":134,"role":62,"phone":135,"phoneExt":64,"email":136},"Caroline Yague Sanz","+32 81 72 04 11","caroline.yaguesanz@chuuclnamur.uclouvain.be",{"name":138,"role":58,"phone":53,"phoneExt":53,"email":53},"Vincent Remouchamps, MD, PhD",{"facility":140,"status":110,"city":141,"state":142,"zip":143,"country":73,"countryCode":74,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Universitair Ziekenhuis Gent (UZGent)","Ghent","Oost Vlaanderen","9000",{"type":76,"coordinates":145},[146,147],3.71667,51.05,{"lat":147,"lon":146},[150,154],{"name":151,"role":62,"phone":152,"phoneExt":64,"email":153},"Jessie De Kinder","+329 332 32 78","jessie.dekinder@uzgent.be",{"name":155,"role":58,"phone":53,"phoneExt":53,"email":53},"Bernard Depypere, MD, PhD",{"facility":157,"status":69,"city":158,"state":159,"zip":160,"country":73,"countryCode":74,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"AZ Groeninge","Kortrijk","West Vlaanderen","8500",{"type":76,"coordinates":162},[163,164],3.26487,50.82803,{"lat":164,"lon":163},[167,171],{"name":168,"role":62,"phone":169,"phoneExt":64,"email":170},"Inge Meyer","+3256 63 39 03","inge.meyer@azgroeninge.be",{"name":172,"role":58,"phone":53,"phoneExt":53,"email":53},"Isabelle Kindts, MD, PhD",{"type":174,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[176,178],{"name":177,"class":6},"Ziekenhuis aan de Stroom",{"name":57,"class":179},"UNKNOWN","100572929","preoperative-radiation-therapy-and-immediate-breast-reconstruction-100572929",false,"NCT06739655","Preoperative Radiation Therapy and Immediate Breast Reconstruction","Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population","PRADAIIBE","Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation.\n\nInclusion criteria:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n1\\. Women ≥18 years with histopathologically confirmed breast cancer who:\n\n1.a. require SSM\u002FNSM for any reason (e.g. extensive disease)\n\n1.b. require postoperative radiation therapy of at least the chest wall\n\n1. c. have a wish for a breast reconstruction\n2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2\n3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.\n\nExclusion criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM\u002FNSM + reconstruction (e.g. in case of a contralateral prophylactic SSM\u002FNSM), or previous contralateral breast cancer disease\u002Ftreatment, do not fall under this criterium and are thus allowed.\n2. Collagen synthesis disease\n3. Ongoing pregnancy\n4. Actively breastfeeding\n5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \\>3months preoperatively.\n6. BMI \\> 35 kg\u002Fm2\n7. cT4d tumour, metastatic disease or any reason making SSM\u002FNSM not indicated","FEMALE","18 Years",{"count":191,"type":192},180,"ESTIMATED","INTERVENTIONAL",[195],"NA","The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed\u002Fimmediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT.\n\nThe following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up:\n\n* Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC?\n* Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? \\[Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies\\]\n\nEligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.",[198,199,200,201,202],"Breast Neoplasms","Breast Carcinoma","Breast Adenocarcinoma","Cancer","Neoplasm",[204,205,206,207,208,209,210,211,212,213,214,215,216,217,218],"Breast cancer","Radiotherapy","PRADA","Breast reconstruction","BreastQ","QoL","Skin Sparing Mastectomy","Mastectomy","Breast surgery","radiation therapy","Preoperative radiation therapy","Preoperative RT","Cosmesis","Breast satisfaction","Immediate Breast Reconstruction","2026-02-02",{"date":221,"type":222},"2026-02-04","ACTUAL",{"date":224,"type":222},"2025-02-20",{"date":226,"type":192},"2038-02-20",{"name":5,"class":6},6]