[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484813":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":67,"studyPopulation":60,"armGroups":68,"interventions":75,"overallOfficials":80,"centralContacts":87,"locations":95,"responsibleParty":402,"collaborators":404,"id":442,"slug":443,"hasResults":444,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":444,"sex":450,"minAge":451,"maxAge":452,"enrollmentInfo":453,"targetDuration":60,"studyType":456,"phases":457,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":98,"whyStopped":60,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":473},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Grade ≥3 toxicity associated with treatment","TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.","During accrual period, up to 3 years",[14,18,21,24,27,30,33,36,39,41,44,47,50,53,57],{"measure":15,"description":16,"timeFrame":17},"Frequency radiation-associated toxicity (acute)","Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.","3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI",{"measure":19,"description":20,"timeFrame":17},"Percentage radiation-associated toxicity (acute)","Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.",{"measure":22,"description":23,"timeFrame":17},"Frequency radiation-associated toxicity (late)","Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.",{"measure":25,"description":26,"timeFrame":17},"Percentage radiation-associated toxicity (late)","Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.",{"measure":28,"description":29,"timeFrame":17},"Risk of local recurrence (invasive and DCIS)","Cumulative incidence function will be used to estimate local recurrence with death as a competing risk.",{"measure":31,"description":32,"timeFrame":17},"Risk of distant recurrence (invasive and DCIS)","Cumulative incidence function will be used to estimate distant recurrence and distance recurrence with death as a competing risk.",{"measure":34,"description":35,"timeFrame":17},"Location of local recurrence (in-field) (frequency)","Location of recurrence will be summarized by frequency.",{"measure":37,"description":38,"timeFrame":17},"Location of local recurrence (in-field) (percentage)","Location of recurrence will be summarized by percentage.",{"measure":40,"description":35,"timeFrame":17},"Location of local recurrence (out-of-field) (frequency)",{"measure":42,"description":43,"timeFrame":17},"Location of local recurrence (out-of-field) (percentage)","Location of recurrence will be summarized by percentage",{"measure":45,"description":46,"timeFrame":17},"Risk of local recurrence after rPBI requiring mastectomy","Cumulative incidence function will be used to estimate local recurrence after rPBI requiring mastectomy with death as a competing risk",{"measure":48,"description":49,"timeFrame":17},"Invasive breast cancer free survival","Kaplan-Meier method will be used to estimate invasive breast cancer free survival",{"measure":51,"description":52,"timeFrame":17},"Overall survival","Kaplan-Meier method will be used to estimate overall survival",{"measure":54,"description":55,"timeFrame":56},"Satisfaction with breasts","Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated.","Baseline, 1 year, 3 years, and 5 years post rPBI",{"measure":58,"description":55,"timeFrame":59},"Financial toxicity associated with treatment","Baseline, 3 months, 1 year, and 3 years post rPBI",null,{"allocation":62,"interventionModel":63,"interventionModelDescription":60,"primaryPurpose":64,"observationalModel":60,"timePerspective":60,"maskingInfo":65},"NA","SINGLE_GROUP","TREATMENT",{"masking":66,"maskingDescription":60,"whoMasked":60},"NONE","Most women affected by breast cancer are treated with breast-conserving surgery to remove the tumour, followed by radiation to reduce the risk of recurrence. Unfortunately, some women will experience recurrence of the cancer in the previously treated breast. These recurrences have historically been treated by removing the whole breast or a second breast-conserving surgery followed by 3 to 5 weeks of radiation. These treatments can negatively impact mental health and quality of life or lead to harmful side effects that could impact the skin, breast, ribs, heart and lungs.\n\nBreast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\\\u003C13% grade \\>3 toxicity).\n\nThe target population for this study is women with localized recurrent or new primary breast cancer in the previously irradiated breast. This is a prospective single arm phase 2 trial of external beam rPBI using 26Gy in 5 fractions delivered daily over 1-week after a second lumpectomy for LR following prior BCS and adjuvant whole or partial breast irradiation. Using a multi-institutional and international network of comprehensive cancer centers, this study will advance global knowledge of how to optimally treat women with this disease.",[69],{"label":70,"type":71,"description":72,"interventionNames":73},"rPBI","EXPERIMENTAL","26Gy in 5 daily fractions over 1-week",[74],"Radiation: rPBI",[76],{"type":77,"name":70,"description":78,"armGroupLabels":79,"otherNames":60},"RADIATION","External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week",[70],[81,85],{"name":82,"affiliation":83,"role":84},"Danielle Rodin, MD","Princess Margaret Cancer Centre","PRINCIPAL_INVESTIGATOR",{"name":86,"affiliation":83,"role":84},"Anne Koch, MD",[88,92],{"name":82,"role":89,"phone":90,"phoneExt":60,"email":91},"CONTACT","(416) 946-6513","danielle.rodin@uhn.ca",{"name":86,"role":89,"phone":93,"phoneExt":60,"email":94},"(416) 946-2919","anne.koch@uhn.ca",[96,115,127,143,161,178,199,214,233,248,257,273,286,298,320,337,353,370,386],{"facility":97,"status":98,"city":99,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"NYU Langone Health","RECRUITING","New York","10016","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-74.00597,40.71427,{"lat":107,"lon":106},[110,114],{"name":111,"role":89,"phone":112,"phoneExt":60,"email":113},"Naamit K Gerber, MD","212-731-5304","naamit.gerber@nyulangone.org",{"name":111,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":116,"status":98,"city":99,"state":99,"zip":117,"country":101,"countryCode":102,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Columbia University Medical Center","10032",{"type":104,"coordinates":119},[106,107],{"lat":107,"lon":106},[122,126],{"name":123,"role":89,"phone":124,"phoneExt":60,"email":125},"Eileen Connolly, MD","646-317-4244","epc2116@cumc.columbia.edu",{"name":123,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":128,"status":98,"city":129,"state":130,"zip":131,"country":101,"countryCode":102,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Virgina Community University Massey Comprehensive Cancer Center","Richmond","Virginia","23298-0037",{"type":104,"coordinates":133},[134,135],-77.46026,37.55376,{"lat":135,"lon":134},[138,142],{"name":139,"role":89,"phone":140,"phoneExt":60,"email":141},"Doug Arthur, M.D.","804.828.0539","douglas.arthur@vcuhealth.org",{"name":139,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":144,"status":98,"city":145,"state":146,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000","Australia","AU",{"type":104,"coordinates":151},[152,153],144.96332,-37.814,{"lat":153,"lon":152},[156,160],{"name":157,"role":89,"phone":158,"phoneExt":60,"email":159},"Keelan Byrne, MD","61 3 8559 8635","keelan.byrne@petermac.org",{"name":157,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":162,"status":98,"city":163,"state":163,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"A.C.Camargo Cancer Center","São Paulo","105401","Brazil","BR",{"type":104,"coordinates":168},[169,170],-46.63611,-23.5475,{"lat":170,"lon":169},[173,177],{"name":174,"role":89,"phone":175,"phoneExt":60,"email":176},"Guilherme Rocha Melo Gondim, MD","55 (11) 2189-5010","guilherme.gondim@accamargo.org.br",{"name":174,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":179,"status":98,"city":180,"state":181,"zip":182,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Royal Victoria Regional Health Centre","Barrie","Ontario","L4M 6M2","Canada","CA",{"type":104,"coordinates":186},[187,188],-79.66634,44.40011,{"lat":188,"lon":187},[191,195,198],{"name":192,"role":89,"phone":193,"phoneExt":60,"email":194},"Jessica Conway, M.D.","(705) 728-9090","conwayj@rvh.on.ca",{"name":196,"role":89,"phone":193,"phoneExt":60,"email":197},"Christiaan Stevens, M.D.","stevensc@rvh.on.ca",{"name":192,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":200,"status":98,"city":201,"state":181,"zip":202,"country":183,"countryCode":184,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"London Health Science Centre - Verspeeten Family Cancer Centre","London","N6A 5W9",{"type":104,"coordinates":204},[205,206],-81.23304,42.98339,{"lat":206,"lon":205},[209,213],{"name":210,"role":89,"phone":211,"phoneExt":60,"email":212},"Joelle Helou, MD","(519) 685-8500 Ext. 53672","joelle.helou@lhsc.on.ca",{"name":210,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":215,"status":98,"city":216,"state":181,"zip":217,"country":183,"countryCode":184,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Lakeridge Health","Oshawa","L1G 2B9",{"type":104,"coordinates":219},[220,221],-78.84957,43.90012,{"lat":221,"lon":220},[224,228,231],{"name":225,"role":89,"phone":226,"phoneExt":60,"email":227},"Dr. Medhat El-Mallah, MD","905-576-8711","melmallah@lh.ca",{"name":229,"role":89,"phone":226,"phoneExt":60,"email":230},"Ashane Somasiri, BSc","asomasiri@lh.ca",{"name":232,"role":84,"phone":60,"phoneExt":60,"email":60},"Dr. Medhat El-Mallah, M.D.",{"facility":234,"status":98,"city":235,"state":181,"zip":236,"country":183,"countryCode":184,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Odette Cancer Centre","Toronto","M4N 3M5",{"type":104,"coordinates":238},[239,240],-79.39864,43.70643,{"lat":240,"lon":239},[243,247],{"name":244,"role":89,"phone":245,"phoneExt":60,"email":246},"Hanbo Chen, MD","416-480-5000","hanbo.chen@sunnybrook.ca",{"name":244,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":83,"status":98,"city":235,"state":181,"zip":249,"country":183,"countryCode":184,"cosmosGeoPoint":250,"geoPoint":252,"contacts":253},"M5G2C4",{"type":104,"coordinates":251},[239,240],{"lat":240,"lon":239},[254,255,256],{"name":82,"role":89,"phone":60,"phoneExt":60,"email":91},{"name":82,"role":84,"phone":60,"phoneExt":60,"email":60},{"name":86,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":258,"status":98,"city":259,"state":260,"zip":261,"country":183,"countryCode":184,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"CHU de Québec-Université Laval","Montreal","Quebec","G1G 5X1",{"type":104,"coordinates":263},[264,265],-73.58781,45.50884,{"lat":265,"lon":264},[268,272],{"name":269,"role":89,"phone":270,"phoneExt":60,"email":271},"Valarie Theberge, MD","(418) 525-4444","valerie.theberge.med@ssss.gouv.qc.ca",{"name":269,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":274,"status":98,"city":259,"state":260,"zip":275,"country":183,"countryCode":184,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal","H1T 2M4",{"type":104,"coordinates":277},[264,265],{"lat":265,"lon":264},[280,283,285],{"name":281,"role":89,"phone":60,"phoneExt":60,"email":282},"Michael Yassa, MD","michael.yassa.med@ssss.gouv.qc.ca",{"name":60,"role":89,"phone":284,"phoneExt":60,"email":60},"514 252-3400",{"name":281,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":287,"status":98,"city":259,"state":260,"zip":288,"country":183,"countryCode":184,"cosmosGeoPoint":289,"geoPoint":291,"contacts":292},"Centre hospitalier de l'Université de Montréal","H2X 3E4",{"type":104,"coordinates":290},[264,265],{"lat":265,"lon":264},[293,297],{"name":294,"role":89,"phone":295,"phoneExt":60,"email":296},"Jean-Marc Bourque, MD","514-890-8254","jean-marc.bourque.med@ssss.gouv.qc.ca",{"name":294,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":299,"status":98,"city":300,"state":301,"zip":302,"country":303,"countryCode":304,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Clinica IRAM","Vitacura","Santiago Metropolitan","7630370","Chile","CL",{"type":104,"coordinates":306},[307,308],-70.58275,-33.39227,{"lat":308,"lon":307},[311,315,319],{"name":312,"role":89,"phone":313,"phoneExt":60,"email":314},"Dr. Valentina Ovalle, M.D.","+56 2 2754 1700","valentina.ovalle@iram.cl",{"name":316,"role":89,"phone":317,"phoneExt":60,"email":318},"Jennyfer Cabrera","+562 2754 1700","jennyfer.cabrera@iram.cl",{"name":312,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":321,"status":98,"city":322,"state":60,"zip":60,"country":323,"countryCode":324,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"Tel-Aviv Sourasky Medical Centre","Tel Aviv","Israel","IL",{"type":104,"coordinates":326},[327,328],34.78057,32.08088,{"lat":328,"lon":327},[331,335],{"name":332,"role":89,"phone":333,"phoneExt":60,"email":334},"Inbal Golomb, M.D.","03-6972805","inbalgo@tlvmc.gov.il",{"name":336,"role":84,"phone":60,"phoneExt":60,"email":60},"Inbal Golomb",{"facility":338,"status":98,"city":339,"state":60,"zip":60,"country":340,"countryCode":341,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"AOU Careggi - Florence University Hospital","Florence","Italy","IT",{"type":104,"coordinates":343},[344,345],11.24626,43.77925,{"lat":345,"lon":344},[348,352],{"name":349,"role":89,"phone":350,"phoneExt":60,"email":351},"Icro Meattini, M.D.","+39 055 2751829","icro.meattini@unifi.it",{"name":349,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":354,"status":98,"city":355,"state":356,"zip":60,"country":356,"countryCode":357,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"King Hussein Cancer Centre","Amman","Jordan","JO",{"type":104,"coordinates":359},[360,361],35.94503,31.95522,{"lat":361,"lon":360},[364,369],{"name":365,"role":89,"phone":366,"phoneExt":367,"email":368},"Fadwa D Abdel Rahman, MD","(962) 6 5300460","7936","faelrahman@khcc.jo",{"name":365,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":371,"status":98,"city":372,"state":60,"zip":60,"country":373,"countryCode":374,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"The Aga Khan University","Nairobi","Kenya","KE",{"type":104,"coordinates":376},[377,378],36.81667,-1.28333,{"lat":378,"lon":377},[381,385],{"name":382,"role":89,"phone":383,"phoneExt":60,"email":384},"Angela Waweru, FRCR","+254 111 011888","angela.waweru@aku.edu",{"name":382,"role":84,"phone":60,"phoneExt":60,"email":60},{"facility":387,"status":98,"city":388,"state":60,"zip":60,"country":389,"countryCode":390,"cosmosGeoPoint":391,"geoPoint":395,"contacts":396},"Universitiy Malaya Medical Centre","Kuala Lumpur","Malaysia","MY",{"type":104,"coordinates":392},[393,394],101.68653,3.1412,{"lat":394,"lon":393},[397,401],{"name":398,"role":89,"phone":399,"phoneExt":60,"email":400},"Po Lin Ooi, MD","+60 3-7949 4422","ooipl@um.edu.my",{"name":398,"role":84,"phone":60,"phoneExt":60,"email":60},{"type":403,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR",[405,407,409,411,413,414,416,418,420,423,425,427,429,431,433,434,436,438,440],{"name":406,"class":6},"Sunnybrook Health Sciences Centre",{"name":179,"class":408},"UNKNOWN",{"name":410,"class":6},"AC Camargo Cancer Center",{"name":412,"class":6},"King Hussein Cancer Center",{"name":97,"class":6},{"name":415,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)",{"name":417,"class":6},"Peter MacCallum Cancer Centre, Australia",{"name":419,"class":6},"CHU de Quebec-Universite Laval",{"name":421,"class":422},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"name":424,"class":6},"Virginia Commonwealth University",{"name":426,"class":408},"AOU Careggi",{"name":428,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":430,"class":6},"Maisonneuve-Rosemont Hospital",{"name":432,"class":6},"Columbia University",{"name":215,"class":6},{"name":435,"class":6},"London Health Sciences Centre",{"name":437,"class":408},"Clínica IRAM",{"name":439,"class":408},"University Malaysia Medical Centre",{"name":441,"class":6},"Aga Khan University","100484813","partial-breast-re-irradiation-using-ultra-hypofractionation-preserve-100484813",false,"NCT05592938","Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)","Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)","PRESERVE","Inclusion Criteria:\n\n* Age \\> 18 years\n* In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)\n* Tumour \\\u003C3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components\n* \\>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)\n* Clinically node negative\n* Negative margins (no tumour on ink)\n* Recovered from surgery with the incision completely healed and no signs of infection\n\nExclusion Criteria:\n\n* Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)\n* Tumour histology limited to lobular carcinoma only\n* T4 disease\n* Node positive or distant metastatic disease\n* Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment\n* Currently pregnant or lactating\n* Presence of an ipsilateral breast implant or pacemaker\n* Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy\n* Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips).\n* Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol\n* Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0\n* Current or prior diagnosis of bilateral breast cancer","FEMALE","18 Years","99 Years",{"count":454,"type":455},171,"ESTIMATED","INTERVENTIONAL",[62],"Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\\\u003C13% grade \\>3 toxicity).",[460,461],"Breast Cancer","Breast Cancer Recurrent",[463],"Hypofractionated","2026-07-15",{"date":466,"type":467},"2026-07-17","ACTUAL",{"date":469,"type":467},"2023-06-27",{"date":471,"type":455},"2027-06-27",{"name":5,"class":6},19]