[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488036":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":11,"armGroups":39,"interventions":50,"overallOfficials":55,"centralContacts":60,"locations":68,"responsibleParty":374,"collaborators":376,"id":380,"slug":11,"hasResults":381,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":381,"sex":387,"minAge":388,"maxAge":11,"enrollmentInfo":389,"targetDuration":11,"studyType":392,"phases":393,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},{"fullName":5,"class":6},"Region Skane","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Recurrence Free Survival",null,"Five years",[14,16,18,20,22,24,27,30],{"measure":15,"description":11,"timeFrame":12},"Locoregional recurrence",{"measure":17,"description":11,"timeFrame":12},"Regional nodal recurrence",{"measure":19,"description":11,"timeFrame":12},"New contralateral breast cancer",{"measure":21,"description":11,"timeFrame":12},"Distant recurrence free survival",{"measure":23,"description":11,"timeFrame":12},"Overall survival",{"measure":25,"description":26,"timeFrame":12},"Arm morbidity","Assessed by questionnaires completed by study participants digitally or on paper between randomization and start of RT, and after 1, 3, and 5 years. The questionnaire used is the Lymphedema Functioning, Disability and Health Questionnaire (Lymph-ICF) developed by Devoogdt in 2011.",{"measure":28,"description":29,"timeFrame":12},"Health-related quality of life","Assessed by the questionnaire EORTC QLQ-C-30 completed by study participants between randomization and RT, and after 1, 3, and 5 years.",{"measure":28,"description":31,"timeFrame":12},"Assessed by the questionnaire BR-23 completed by study participants between randomization and RT, and after 1, 3, and 5 years.",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":11,"whoMasked":11},"NONE","In this multicenter, prospective randomized trial clinically node-negative breast cancer patients with 1-2 macrometastases in their sentinel lymph node biopsy, and an estrogen receptor positive, HER2-negative tumor, will be randomly assigned to either receive adjuvant locoregional radiotherapy, or no regional radiotherapy.\n\nThe main aim is to evaluate whether regional radiotherapy may safely be omitted in patients with limited lymph node metastasis and an estimated low risk of locoregional recurrence. Recurrence free survival after five years is the primary outcome, which for non-inferiority should not worsen more than 4.5 percentage units. Secondary outcomes are locoregional recurrence, regional nodal recurrence, new contralateral BC, distant recurrence free survival, overall survival, non-breast malignancies, cardiac disease, arm morbidity, and health-related quality of life.\n\nTarget volumes include:\n\nStandard arm - The remaining breast\u002Fchest wall, axillary lymph node levels I-III, the supraclavicular lymph nodes (level IV), the interpectoral lymph nodes and in patients with a medial\u002Fcentral tumor also the internal mammary lymph nodes.\n\nIntervention arm - The remaining breast after breast conserving surgery. No radiotherapy after mastectomy",[40,44],{"label":41,"type":42,"description":43,"interventionNames":11},"Standard","NO_INTERVENTION","Radiotherapy to the remaining breast after breast conserving surgery or chest wall after mastectomy, and regional axillary lymph node levels I-IV. Internal mammary nodes are included in the target volume if the tumor has a central\u002Fmedial localization in the breast.",{"label":45,"type":46,"description":47,"interventionNames":48},"Intervention","EXPERIMENTAL","No regional radiotherapy. Radiotherapy is given to the remaining breast after breast conserving surgery. Chest wall radiotherapy after mastectomy only in case of wide spread multifocality.",[49],"Radiation: De-escalation",[51],{"type":52,"name":53,"description":47,"armGroupLabels":54,"otherNames":11},"RADIATION","De-escalation",[45],[56],{"name":57,"affiliation":58,"role":59},"Sara Alkner, Associate professor","Lunds Universitet","PRINCIPAL_INVESTIGATOR",[61,65],{"name":57,"role":62,"phone":63,"phoneExt":11,"email":64},"CONTACT","+4646171000","sara.alkner@med.lu.se",{"name":66,"role":62,"phone":63,"phoneExt":11,"email":67},"T-REX Clinical Trials Office","T_Rex.onkologi@skane.se",[69,85,96,106,118,127,136,146,155,164,173,182,191,203,214,224,235,245,255,265,275,285,295,305,314,324,334,344,354,364],{"facility":70,"status":71,"city":72,"state":11,"zip":11,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Helsinki University 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Uppsala","Uppsala",{"type":76,"coordinates":348},[349,350],17.63889,59.85882,{"lat":350,"lon":349},[353],{"name":83,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":355,"status":71,"city":356,"state":11,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Region Kronoberg","Vaxjo",{"type":76,"coordinates":358},[359,360],14.80906,56.87767,{"lat":360,"lon":359},[363],{"name":83,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":365,"status":71,"city":366,"state":11,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"Region Västmanland","Västerås",{"type":76,"coordinates":368},[369,370],16.55276,59.61617,{"lat":370,"lon":369},[373],{"name":83,"role":62,"phone":11,"phoneExt":11,"email":11},{"type":375,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[377],{"name":378,"class":379},"Exact Sciences Corporation","INDUSTRY","100488036",false,"NCT05634889","The T-REX Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases.","The T-REX-Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases; an Open, Multicenter, Randomized Non-inferiority Phase 3-trial.","T-REX","Inclusion Criteria:\n\n1. Primary unifocal or multifocal invasive breast cancer T1-T2.\n2. Clinically N0.\n3. Macrometastasis (\\>2mm) in 1-2 lymph nodes at sentinel node biopsy.\n4. Oral and written consent.\n5. Age ≥ 18 years.\n6. All resection margins are tumor free (no tumor on ink).\n7. Primary tumor ER-positive, HER2-negative.\n\nExclusion Criteria:\n\n1. Regional or distant metastases outside the ipsilateral axilla.\n2. Previous RT towards the planned target area, i.e. the ipsilateral chest\u002Flymph nodes.\n3. Neoadjuvant systemic therapy.\n4. Axillary lymph node dissection or other previous axillary surgery on the affected side.\n5. Prior history of invasive breast cancer.\n6. Pregnancy.\n7. Bilateral invasive breast cancer.\n8. Contraindication for radiotherapy or systemic treatment.\n9. Inability to absorb or understand the contents of the informed consent form; for example, through disability, inadequate language skills or dementia.\n10. Other invasive cancer within 5 years prior to breast cancer diagnosis","ALL","18 Years",{"count":390,"type":391},1350,"ESTIMATED","INTERVENTIONAL",[394],"NA","T-REX is a randomized multicenter, non-inferiority trial.\n\nAim: To evaluate whether regional radiotherapy may safely be omitted in clinically node negative breast cancer patients with one or two sentinel node macrometastases and an estrogen receptor positive, HER2-negative tumor. Leading to an improved quality of life and reduced side effects, without worsening recurrence free survival at five years.\n\nIntervention: Patients will be randomized to locoregional radiotherapy towards the breast\u002Fchestwall and regional lymph nodes vs. to a de-escalated radiotherapy.\n\nIn the intervention arm no lymph node irradiation will be given. Radiotherapy is still given to the remaining breast after breast conserving surgery, but no radiotherapy is given after mastectomy.\n\nSample size: 1350 patients\n\nPrimary end-point: Recurrence free survival at five years.\n\nGene expression analysis: For all patients gene expression analysis for the gene signatures ARTIC, POLAR and OncotypeDX will be performed and related to risk of recurrence and benefit of adjuvant radiotherapy.",[397],"Breast Cancer",[399,400,401,402,403],"breast cancer","radiotherapy","gene expression analysis","adjuvant breast cancer treatment","regional breast cancer treatment","2026-05-08",{"date":406,"type":407},"2026-05-11","ACTUAL",{"date":409,"type":407},"2023-03-17",{"date":411,"type":391},"2033-12-31",{"name":5,"class":6},30]