[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468228":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":34,"armGroups":43,"interventions":54,"overallOfficials":60,"centralContacts":65,"locations":75,"responsibleParty":411,"collaborators":413,"id":448,"slug":449,"hasResults":450,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":450,"sex":456,"minAge":457,"maxAge":34,"enrollmentInfo":458,"targetDuration":34,"studyType":461,"phases":462,"briefSummary":464,"conditions":465,"keywords":468,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)","Time from the date of randomisation to the date of disease-progression at any site or death from any cause.","3 years after the last patient inclusion",[14,17,20,24,27,31],{"measure":15,"description":16,"timeFrame":12},"Overall survival (OS)","Time from the date of randomisation to the date of death from any cause.",{"measure":18,"description":19,"timeFrame":12},"Local Control Rate (LCR)","Time from the date of randomisation to the date of progress in previously treated metastases",{"measure":21,"description":22,"timeFrame":23},"Safety analysis - acute toxicity","Reported according to CTCAE v.5.0","From the first dose of SABR to 3 months after the last dose of SABR",{"measure":25,"description":22,"timeFrame":26},"Safety analysis - late toxicity","From the first dose of SABR to 3 years after the last dose of SABR",{"measure":28,"description":29,"timeFrame":30},"Health-related quality of life Cancer-30","European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30)","At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.",{"measure":32,"description":33,"timeFrame":30},"Health-related quality of life Breast-23","European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23)",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Randomisation 2:1 (systemic treatment + SABR vs systemic treatment)","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE","TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.\n\nPatients with 1-5 metastases in 1-2 organs (confirmed by PET-CT) with any breast cancer subtype can be enrolled. All metastases must be available for SABR.\n\nThe primary aim is to investigate if the addition of SABR to the oligometastatic sites in addition to the standard first-line treatment can improve progression-free survival (PFS).\n\nSecondary aims are to compare overall survival (OS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients).\n\nExploratory analyses:\n\nCirculating tumour DNA as an early sign of disease progression. Immun panel for determination of the effect of SABR on patients´ immune response.\n\nTo investigate the survival for each BC subtype (Luminal, HER2+ and TNBC). To investigate survival in patients with de novo OMBC and recurrent OMBC respectively.\n\nStratifications are based on subtype (luminal, HER2-positive vs TNBC) and type of OMBC (de novo vs. recurrent) without formal sample size calculation for the stratification factor (exploratory analysis).\n\nPatients with de novo metastatic OMBC that is planned for neoadjuvant treatment are recommended to complete treatment followed by standard surgery and radiotherapy or SABR towards the primary tumour lesion(s).",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Experimental SABR arm","EXPERIMENTAL","Standard first line systemic therapy + SABR.",[49],"Radiation: SABR",{"label":51,"type":52,"description":53,"interventionNames":34},"Control systemic therapy arm","NO_INTERVENTION","Standard first line systemic therapy.",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"RADIATION","SABR","Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.",[45],[61],{"name":62,"affiliation":63,"role":64},"Barbro K Linderholm, MD, PhD","Sahlgrenska University Hospital, Gothenburg","PRINCIPAL_INVESTIGATOR",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":34,"email":70},"Katarzyna Kulbacka-Ortiz, CTO","CONTACT","+46721470685","katarzyna.kulbacka-ortiz@vgregion.se",{"name":72,"role":68,"phone":73,"phoneExt":34,"email":74},"Annika Baan","+46700906097","annika.baan@vgregion.se",[76,96,109,124,140,161,179,194,206,223,242,261,280,301,320,336,353,374,395],{"facility":77,"status":78,"city":79,"state":34,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Cork University Hospital","RECRUITING","Cork","T12 DC4A","Ireland","IE",{"type":84,"coordinates":85},"Point",[86,87],-8.47061,51.89797,{"lat":87,"lon":86},[90,94],{"name":91,"role":68,"phone":92,"phoneExt":34,"email":93},"Ella O'Sullivan, MD","+353 (0) 21 4922000","ella.osullivan@hse.ie",{"name":95,"role":64,"phone":34,"phoneExt":34,"email":34},"Aisling Barry, Prof.",{"facility":97,"status":78,"city":79,"state":34,"zip":98,"country":81,"countryCode":82,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Bon Secours Cork In Partnership with UPMC Hillman Cancer Centre","T12 DV56",{"type":84,"coordinates":100},[86,87],{"lat":87,"lon":86},[103,107],{"name":104,"role":68,"phone":105,"phoneExt":34,"email":106},"Karen Molan, MD","+353 (0)21-486 1100","molank@upmc.ie",{"name":108,"role":64,"phone":34,"phoneExt":34,"email":34},"Kathy Rock, MD",{"facility":110,"status":78,"city":111,"state":34,"zip":34,"country":81,"countryCode":82,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital Dublin, St James Hospital Dublin and Beaumont Hospital Dublin","Dublin",{"type":84,"coordinates":113},[114,115],-6.24889,53.33306,{"lat":115,"lon":114},[118,122],{"name":119,"role":68,"phone":120,"phoneExt":34,"email":121},"Vitor Oliviera","+353 (0) -1-420 6900","Vitor.Oliveira@slh.ie",{"name":123,"role":64,"phone":34,"phoneExt":34,"email":34},"Frances Duane, Prof.",{"facility":125,"status":78,"city":126,"state":34,"zip":127,"country":81,"countryCode":82,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"University Hospital Galway (UHG)","Galway","H91 YR71",{"type":84,"coordinates":129},[130,131],-9.05095,53.27245,{"lat":131,"lon":130},[134,138],{"name":135,"role":68,"phone":136,"phoneExt":34,"email":137},"Laura Nally","+353 91 54 2785","laura.nally@hse.ie",{"name":139,"role":64,"phone":34,"phoneExt":34,"email":34},"Ronan McDermott, MD",{"facility":141,"status":78,"city":142,"state":34,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Sheba Medical Center Institute of Oncology","Tel Aviv","5265601","Israel","IL",{"type":84,"coordinates":147},[148,149],34.78057,32.08088,{"lat":149,"lon":148},[152,156,159],{"name":153,"role":68,"phone":154,"phoneExt":34,"email":155},"Aliza Ackerstein","+972-3-5302542","aliza.ackerstein@sheba.health.gov.il",{"name":157,"role":68,"phone":34,"phoneExt":34,"email":158},"Chen Gross","Chen.Gross@sheba.health.gov.il",{"name":160,"role":64,"phone":34,"phoneExt":34,"email":34},"Einav Nili Gal-Yam, MD",{"facility":162,"status":78,"city":163,"state":34,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Azienda Ospedaliero - Universitaria Careggi","Florence","3 50134","Italy","IT",{"type":84,"coordinates":168},[169,170],11.24626,43.77925,{"lat":170,"lon":169},[173,177],{"name":174,"role":68,"phone":175,"phoneExt":34,"email":176},"Michela Carracino","+390552751828","carracinom@aou-careggi.toscana.it",{"name":178,"role":64,"phone":34,"phoneExt":34,"email":34},"Icro Meattini, Prof.",{"facility":180,"status":78,"city":181,"state":34,"zip":34,"country":165,"countryCode":166,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Humanitas Cancer Centre","Milan",{"type":84,"coordinates":183},[184,185],12.59836,42.78235,{"lat":185,"lon":184},[188,192],{"name":189,"role":68,"phone":190,"phoneExt":34,"email":191},"Marta Scorsetti, MD, PhD","+39 02 8224 8524","marta.scorsetti@hunimed.eu",{"name":193,"role":64,"phone":34,"phoneExt":34,"email":34},"Marta Scorsetti, Prof.",{"facility":195,"status":78,"city":181,"state":34,"zip":34,"country":165,"countryCode":166,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"Istituto Nationale Tumori (INT)",{"type":84,"coordinates":197},[184,185],{"lat":185,"lon":184},[200,204],{"name":201,"role":68,"phone":202,"phoneExt":34,"email":203},"Maria Carmen De Santis, MD","+39-0223903280","mariacarmen.desantis@istitutotumori.mi.it",{"name":205,"role":64,"phone":34,"phoneExt":34,"email":34},"Maria Carmen De Santis, Prof.",{"facility":207,"status":78,"city":208,"state":34,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Haukeland University Hospital","Bergen","5021","Norway","NO",{"type":84,"coordinates":213},[214,215],5.32415,60.39299,{"lat":215,"lon":214},[218,222],{"name":219,"role":68,"phone":220,"phoneExt":34,"email":221},"Vidhi Shukla, MD","+47 55 97 50 00","vidi.shukla@helse-bergen.no",{"name":219,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":224,"status":78,"city":225,"state":34,"zip":226,"country":210,"countryCode":211,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Oslo University Hospital, Radiumhospitalet","Oslo","0424",{"type":84,"coordinates":228},[229,230],10.74609,59.91273,{"lat":230,"lon":229},[233,237,240],{"name":234,"role":68,"phone":235,"phoneExt":34,"email":236},"Veronica Feilum","+47-942244","uxfeve@ous-hf.no",{"name":238,"role":68,"phone":34,"phoneExt":34,"email":239},"Maria Elena Rodriguez Aguillar","maerod@ous-hf.no",{"name":241,"role":64,"phone":34,"phoneExt":34,"email":34},"Vidar Gordon Flote, MD, PhD",{"facility":243,"status":78,"city":244,"state":34,"zip":245,"country":210,"countryCode":211,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Universitetssykehuset Nord-Norge","Tromsø","9019",{"type":84,"coordinates":247},[248,249],18.95508,69.6489,{"lat":249,"lon":248},[252,256,259],{"name":253,"role":68,"phone":254,"phoneExt":34,"email":255},"Kristin Iren Jensen","+ 47 77 66 92 12","Kristin.Iren.Jensen@unn.no",{"name":257,"role":68,"phone":34,"phoneExt":34,"email":258},"Maria Therese Danielsen","maria.theres.danielsen@unn.no",{"name":260,"role":64,"phone":34,"phoneExt":34,"email":34},"Hanna Stromholt Bremnes, MD",{"facility":262,"status":78,"city":263,"state":34,"zip":264,"country":210,"countryCode":211,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"St. Olavs Hospital","Trondheim","7006",{"type":84,"coordinates":266},[267,268],10.39506,63.43049,{"lat":268,"lon":267},[271,275,278],{"name":272,"role":68,"phone":273,"phoneExt":34,"email":274},"Kjerstin Olaussen","+47-72825782","Kjerstin.Olaussen@stolav.no",{"name":276,"role":68,"phone":34,"phoneExt":34,"email":277},"Britt Torun Fjær Nydal","Britt.Torunn.Fjer.Nydal@stolav.no",{"name":279,"role":64,"phone":34,"phoneExt":34,"email":34},"Solveig Hoff",{"facility":281,"status":78,"city":282,"state":34,"zip":283,"country":284,"countryCode":285,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Institute of Oncology Ljubljana","Ljubljana","1000","Slovenia","SI",{"type":84,"coordinates":287},[288,289],14.50513,46.05108,{"lat":289,"lon":288},[292,296,299],{"name":293,"role":68,"phone":294,"phoneExt":34,"email":295},"Minka Macanovic","+386 (0)1 58 79 550","mmacanovic@onko-i.si",{"name":297,"role":68,"phone":34,"phoneExt":34,"email":298},"Erika Primc","eprimc@onko-i.si",{"name":300,"role":64,"phone":34,"phoneExt":34,"email":34},"Ivica Ratoša, MD",{"facility":302,"status":78,"city":303,"state":304,"zip":305,"country":306,"countryCode":307,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Ryhov County Hospital","Jönköping","Region Jönköpings Län","551 85","Sweden","SE",{"type":84,"coordinates":309},[310,311],14.15618,57.78145,{"lat":311,"lon":310},[314,318],{"name":315,"role":68,"phone":316,"phoneExt":34,"email":317},"Therese Karlsson, Study nurse","+46 10-242 59 62","therese.i.karlsson@rjl.se",{"name":319,"role":64,"phone":34,"phoneExt":34,"email":34},"Maria Ekholm, MD, PhD",{"facility":321,"status":78,"city":322,"state":323,"zip":34,"country":306,"countryCode":307,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Skånes University Hospital","Malmö","Region Skåne",{"type":84,"coordinates":325},[326,327],13.00073,55.60587,{"lat":327,"lon":326},[330,334],{"name":331,"role":68,"phone":332,"phoneExt":34,"email":333},"Charlotta Wollheim, Study nurse","+46 40 337461","charlotta.wollheim@skane.se",{"name":335,"role":64,"phone":34,"phoneExt":34,"email":34},"Muhammad Kadum, MD",{"facility":337,"status":78,"city":338,"state":339,"zip":340,"country":306,"countryCode":307,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Karolinska University Hospital","Stockholm","Region Stockholm","17176",{"type":84,"coordinates":342},[343,344],18.06871,59.32938,{"lat":344,"lon":343},[347,351],{"name":348,"role":68,"phone":349,"phoneExt":34,"email":350},"Karin Hedgren, Study nurse","+46-8-123 71746","karin.hedgren@regionstockholm.se",{"name":352,"role":64,"phone":34,"phoneExt":34,"email":34},"Caroline Boman, MD",{"facility":354,"status":78,"city":355,"state":356,"zip":357,"country":306,"countryCode":307,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"Norrlands University Hospital","Umeå","Region Västerbotten","901 85",{"type":84,"coordinates":359},[360,361],20.25972,63.82842,{"lat":361,"lon":360},[364,368,372],{"name":365,"role":68,"phone":366,"phoneExt":34,"email":367},"Dmitry Domkin, Study nurse","+46 90-785 35 95","dmitry.domkin@regionvasterbotten.se",{"name":369,"role":68,"phone":370,"phoneExt":34,"email":371},"Jeanette Johansson, Study nurse","+46-90-785 06 89","jeanette.johansson@regionvasterbotten.se",{"name":373,"role":64,"phone":34,"phoneExt":34,"email":34},"Kristina Weibring, MD, PhD",{"facility":375,"status":78,"city":376,"state":377,"zip":378,"country":306,"countryCode":307,"cosmosGeoPoint":379,"geoPoint":383,"contacts":384},"Örebro University Hospital","Örebro","Region Örebro Län","SE-701 85",{"type":84,"coordinates":380},[381,382],15.2066,59.27412,{"lat":382,"lon":381},[385,389,393],{"name":386,"role":68,"phone":387,"phoneExt":34,"email":388},"Emma Nordh, Study nurse","+46 19 602 27 19","emma.nordh@regionorebrolan.se",{"name":390,"role":68,"phone":391,"phoneExt":34,"email":392},"Jenny Larsson, Study nurse","+46-31-3426791","jenny.larsson4@regionorebrolan.se",{"name":394,"role":64,"phone":34,"phoneExt":34,"email":34},"Eva Tegnelius, MD",{"facility":396,"status":78,"city":397,"state":398,"zip":399,"country":306,"countryCode":307,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"Sahlgrenska University Hospital","Gothenburg","Västra Götalandsregionen","41345",{"type":84,"coordinates":401},[402,403],11.96679,57.70716,{"lat":403,"lon":402},[406,408],{"name":407,"role":68,"phone":34,"phoneExt":34,"email":70},"Katarzyna Kulbacka, Head CTO",{"name":409,"role":68,"phone":391,"phoneExt":34,"email":410},"Mitra Sharifi Jahanfard, Study nurse","mitra.sharifi-jahanfard@vgregion.se",{"type":412,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[414,416,418,420,422,423,425,427,428,429,431,433,435,436,438,440,443,445,446],{"name":396,"class":415},"OTHER",{"name":417,"class":415},"Azienda Ospedaliero-Universitaria Careggi",{"name":419,"class":415},"Region Örebro County",{"name":421,"class":415},"Skane University Hospital",{"name":337,"class":415},{"name":424,"class":415},"University Hospital, Umeå",{"name":426,"class":415},"Oslo University Hospital",{"name":262,"class":415},{"name":207,"class":415},{"name":430,"class":415},"University Hospital of North Norway",{"name":432,"class":415},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"name":434,"class":415},"Humanitas Research Hospital IRCCS, Rozzano-Milan",{"name":77,"class":415},{"name":437,"class":415},"St. James's Hospital, Ireland",{"name":439,"class":415},"Beaumont Hospital",{"name":441,"class":442},"Bon Secours Cork Cancer Centre","UNKNOWN",{"name":444,"class":442},"Galway University Hospitals",{"name":281,"class":415},{"name":447,"class":6},"Sheba Medical Center","100468228","stereotactic-ablative-radiotherapy-for-oligometastatic-breast-cancer-100468228",false,"NCT05377047","Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer","Treatment of Oligometastatic Breast Cancer - a Randomised Phase 3 Trial Comparing Stereotactic Ablative Radiotherapy and Systemic Treatment With Systemic Treatment Alone as 1st Line Treatment","TAORMINA","Inclusion Criteria:\n\n1. Histologically or cytological confirmed recurrent OMBC.\n2. Age ≥18 years old.\n3. OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.\n4. Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.\n5. Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.\n6. Patients with local recurrence and OMBC must have a controlled local recurrence.\n7. ECOG\u002FWHO 0-2.\n8. Life expectancy \\> 6 months.\n9. Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).\n10. Symptomatic bone metastases are allowed if ablative therapy can be delivered.\n11. Adequate organ function for the planned treatment according to local guide-lines.\n12. For patients with liver metastasis:\n\n    * No cirrhosis or hepatitis\n    * Hepatic function:\n\n      * Total bilirubin level \\\u003C 3.0 x institutional ULN\n      * ALT, AST, GGT, and alkaline phosphatase levels \\\u003C 3.0 x institutional ULN\n      * Albumin \\> 2.5 mg\u002FdL\n    * Metastasis not adjutant to stomach or small bowel.\n13. For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \\> 60mL\u002Fmin.\n14. Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator.\n15. Negative pregnancy test within 14 days prior to start of treatment\\*.\n16. If childbearing potential, willing to use an effective form of contraception\\*.\n17. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.\n18. Signed informed consent and willingness to follow the trial procedures.\n\nExclusion Criteria:\n\n1. \\> 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included). Change due to toxicity allowed.\n2. Oligometastases in brain.\n3. Malignant pleural effusion or ascites.\n4. Metastasis growth that involves \\> 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit.\n5. Unable to undergo imaging by either CT scan or MRI.\n6. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.\n7. Pregnancy or breast-feeding.\n8. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).","ALL","18 Years",{"count":459,"type":460},345,"ESTIMATED","INTERVENTIONAL",[463],"PHASE3","TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.",[466,467],"Breast Cancer Stage IV","Oligometastatic Disease",[469,57,470],"SBRT","OMBC","2026-09-16",{"date":473,"type":474},"2026-09-21","ACTUAL",{"date":476,"type":474},"2022-09-19",{"date":478,"type":460},"2030-12-31",{"name":5,"class":6},19]