[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640673":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":30,"armGroups":26,"interventions":31,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":116,"collaborators":26,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":26,"enrollmentInfo":128,"targetDuration":26,"studyType":131,"phases":26,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"real-world progression-free survival","To describe the real-world progression-free survival (rwPFS) of T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries","18 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"safety profile","To assess the safety profile (in terms of incidence and severity of adverse events \\[AEs\\], particularly treatment-emergent AEs (TEAEs) and those of special interest) and reasons for treatment discontinuation during the period with active treatment on T-DXd in the GCC countries.",{"measure":18,"description":19,"timeFrame":12},"baseline patient characteristics","To assess the baseline patient characteristics and clinical presentation of patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries.",{"measure":21,"description":22,"timeFrame":12},"T-DXd treatment patterns","To describe the T-DXd treatment patterns and the lines of ET prior to T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC in the GCC countries.",{"measure":24,"description":25,"timeFrame":12},"real-world time to next treatment (TTNT)","To describe the real-world time to next treatment (TTNT) of T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"CASE_ONLY","PROSPECTIVE","The study population will consist of adult (age ≥ 18 years old at the date of T-DXd initiation) female patients with a confirmed diagnosis of HR-positive, HER2-low (defined as immunohistochemistry \\[IHC\\] 1+ or IHC 2+\u002FIn situ hybridization \\[ISH\\]-) or HER2-ultralow (IHC 0 with membrane staining) mBC that has progressed on one or more ET in the metastatic setting and initiated T-DXd up to 30 days before the index date.",[32],{"type":33,"name":34,"description":35,"armGroupLabels":26,"otherNames":26},"DRUG","TDxd","Observing Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Study Information Center","CONTACT","+18772409479","information.center@astrazeneca.com",[43,55,64,74,81,89,93,102,109],{"facility":44,"status":45,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"Research Site","NOT_YET_RECRUITING","Muscat","Oman","OM",{"type":50,"coordinates":51},"Point",[52,53],58.40778,23.58413,{"lat":53,"lon":52},{"facility":44,"status":45,"city":56,"state":26,"zip":26,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":26},"Doha","Qatar","QA",{"type":50,"coordinates":60},[61,62],51.53096,25.28545,{"lat":62,"lon":61},{"facility":44,"status":45,"city":65,"state":66,"zip":26,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":26},"Mecca","Mecca Region","Saudi Arabia","SA",{"type":50,"coordinates":70},[71,72],39.82563,21.42664,{"lat":72,"lon":71},{"facility":44,"status":45,"city":75,"state":26,"zip":26,"country":67,"countryCode":68,"cosmosGeoPoint":76,"geoPoint":80,"contacts":26},"Jeddah",{"type":50,"coordinates":77},[78,79],39.18624,21.49012,{"lat":79,"lon":78},{"facility":44,"status":82,"city":83,"state":26,"zip":26,"country":67,"countryCode":68,"cosmosGeoPoint":84,"geoPoint":88,"contacts":26},"RECRUITING","Riyadh",{"type":50,"coordinates":85},[86,87],46.72185,24.68773,{"lat":87,"lon":86},{"facility":44,"status":45,"city":83,"state":26,"zip":26,"country":67,"countryCode":68,"cosmosGeoPoint":90,"geoPoint":92,"contacts":26},{"type":50,"coordinates":91},[86,87],{"lat":87,"lon":86},{"facility":44,"status":45,"city":94,"state":26,"zip":26,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":26},"Abu Dhabi","United Arab Emirates","AE",{"type":50,"coordinates":98},[99,100],54.39696,24.45118,{"lat":100,"lon":99},{"facility":44,"status":45,"city":103,"state":26,"zip":26,"country":95,"countryCode":96,"cosmosGeoPoint":104,"geoPoint":108,"contacts":26},"Al Ain City",{"type":50,"coordinates":105},[106,107],55.76056,24.19167,{"lat":107,"lon":106},{"facility":44,"status":45,"city":110,"state":26,"zip":26,"country":95,"countryCode":96,"cosmosGeoPoint":111,"geoPoint":115,"contacts":26},"Dubai",{"type":50,"coordinates":112},[113,114],55.30927,25.07725,{"lat":114,"lon":113},{"type":117,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640673","beyond-study-a-multicentre-prospective-observational-study-of-real-world-treatment-patterns-and-outcomes-of-trastuzumab-deruxtecan-in-patients-with-hr-positive-her2-low-or-ultra-low-metastatic-breast-cancer-previously-treated-with-endocrine-therapy-100640673",false,"NCT07597993","BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy","A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy","BEYOND","Inclusion Criteria:\n\n* -Female patients aged ≥18 years old at the time of T-DXd initiation\n* Patients with a confirmed histological or cytologically based diagnosis of HR-positive mBC.\n* Patients who were classified as HER2-low or HER2-ultralow mBC confirmed by the closest locally obtained HER2 test prior to or on the index date, and who meet the following definitions:\n* HER2-low status defined as IHC scores 1+ and 2+ without ISH gene amplification based on the pathology report.\n* HER2-ultralow status defined as IHC 0 with membrane staining based on the pathology report.\n* Patient who received at least one prior line of ET (± targeted therapy) in the metastatic setting.\n* Patients who are chemotherapy-naïve in the metastatic setting.\n* Patients who initiated T-DXd up to 30 days before the signature of the ICF. The decision to initiate T-DXd must be made independently by treating physicians as part of routine clinical practice.\n* Patients are willing to sign the written ICF, indicating that they understand the purpose of the study and procedures required for participation.\n\nExclusion Criteria:\n\n* -Patients with a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.\n* Patients who received prior chemotherapy in the metastatic setting.\n* Patients with Eastern Cooperative Oncology Group (ECOG) status ≥2 or missing ECOG status at the time of initiation of T-DXd (index date).\n* Patients with a history of participation in another clinical trial in the metastatic setting.\n* Female patient with current or planned pregnancy, or breastfeeding.","FEMALE","18 Years",{"count":129,"type":130},109,"ESTIMATED","OBSERVATIONAL","BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow mBC previously treated with ET. The evidence generated will help to optimise treatment strategies, inform clinical guidelines, and ultimately improve outcomes for patients with mBC across the region.",[134],"Breast Cancer",[136,137],"breast cancer","Trastuzumab Deruxtecan","2026-08-06",{"date":140,"type":141},"2026-08-10","ACTUAL",{"date":143,"type":141},"2026-07-12",{"date":145,"type":130},"2029-03-31",{"name":5,"class":6},9]