[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571974":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":87,"studyPopulation":88,"armGroups":66,"interventions":89,"overallOfficials":66,"centralContacts":94,"locations":100,"responsibleParty":250,"collaborators":66,"id":252,"slug":253,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":254,"sex":260,"minAge":261,"maxAge":66,"enrollmentInfo":262,"targetDuration":66,"studyType":265,"phases":66,"briefSummary":266,"conditions":267,"keywords":66,"overallStatus":123,"whyStopped":66,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Real-world Time to Next Treatment (rwTTNT1, median, 95% CI, measured in months)","The duration from initiation of trastuzumab deruxtecan (T-DXd) treatment to the start of the subsequent therapy or death from any cause, whichever occurs first, assessed up to 19 months.","Baseline up to 19 months",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,57],{"measure":15,"description":16,"timeFrame":17},"Describe type and proportion of previous treatments for unresectable or mBC and comorbidities","Prior treatments: surgery, chemotherapy, radiotherapy, therapies in neoadjuvant\u002Fadjuvant\u002Fadvanced setting; treatment line (special focus should be given on endocrine and chemotherapy recycling in the metastatic setting). The timeline for these treatments will include all therapies administered from the time of breast cancer diagnosis.","Baseline",{"measure":19,"description":20,"timeFrame":17},"Duration of previous treatments and number of treatment lines","Start and stop date, if available",{"measure":22,"description":23,"timeFrame":17},"Response to previous treatments","To describe patients' response to previous treatment, as applicable: clinical response (partial response\u002Fcomplete response\u002Fstable disease\u002Fdisease progression; if progression: date and site of progression)",{"measure":25,"description":26,"timeFrame":17},"Mean (SD) age at diagnosis","Describe the patients' mean (SD) age at diagnosis",{"measure":28,"description":29,"timeFrame":17},"Mean (SD) age at T-DXd start","To describe patients' mean (SD) age at T-DXd start",{"measure":31,"description":32,"timeFrame":17},"Proportion of males and females","To describe the proportion of males and females",{"measure":34,"description":35,"timeFrame":17},"Proportion of patients with HR+ vs HR- tumors","Describe the proportion of patients with HR+ vs HR- tumors",{"measure":37,"description":38,"timeFrame":17},"Distribution by smoking status","Describe the patients' smoking status. Includes electronic cigarettes\u002Fvapes",{"measure":40,"description":41,"timeFrame":17},"Type and proportion of comorbidities","Comorbidities (including cardiovascular diseases, pulmonary disorders, hepatic disorders, renal disorders, blood and lymphatic system disorders, metabolism and nutrition disorders, gastrointestinal disorders, hepatobiliary disorders, central nervous system \\[CNS\\] disorders, eye disorders, skin disorders and musculoskeletal and connective tissue disorders, infections and infestations and other relevant",{"measure":43,"description":44,"timeFrame":17},"Distribution by ECOG status","Describe patients' ECOG PS at index date",{"measure":46,"description":47,"timeFrame":17},"mean (SD) duration of disease (at index), measured in months or years","Describe patients' mean duration of disease through date of initial diagnosis and date of diagnosis of unresectable or metastatic breast cancer, as applicable",{"measure":49,"description":50,"timeFrame":17},"HER2-low status and type and proportion of metastatic sites","Describe patients' HER2-low status and type and proportion of metastatic sites through most recent HER2-low status, new metastatic sites since the time of mBC diagnosis, disease burden (all disease sites, including the presence\u002Fabsence of brain metastases \\[stable\u002Factive\\]",{"measure":52,"description":53,"timeFrame":12},"rwTTNT1 by Number of Prior of Therapy Lines for Metastatic Disease (median, 95% CI, measured in months, 1 vs 2 vs 3+ Lines)","Describe rwTTNT1 stratified by the number of prior therapy lines in the metastatic setting.",{"measure":55,"description":56,"timeFrame":12},"rwTTNT1 by HR-status (median, 95% CI, measured in months, HR+ vs HR-)","Describe rwTTNT1 stratified by hormone receptor (HR) status.",{"measure":58,"description":59,"timeFrame":12},"Real-world Time to Treatment Discontinuation (rwTTD1, median, 95% CI, measured in months)","Evaluate the duration from the start of T-DXd treatment until its discontinuation or death, whichever occurs first.",[61,64,67,69,71,75,78,81],{"measure":62,"description":63,"timeFrame":12},"Real-world Progression-Free Survival (rwPFS1, median, 95% CI, measured in months)","Evaluate the duration from the start of T-DXd treatment until disease progression or death, whichever occurs first.",{"measure":65,"description":66,"timeFrame":12},"Real-world Time to Second Next Treatment (rwTTNT2, median, 95% CI, in months)",null,{"measure":68,"description":66,"timeFrame":12},"Real-world Time to Subsequent Treatment Discontinuation (rwTTD2, median, 95% CI, measured in months)",{"measure":70,"description":66,"timeFrame":12},"Real-world progression free survival 2 (rwPFS2, median, 95% CI, measured in months)",{"measure":72,"description":73,"timeFrame":74},"Biopsy Patterns (number of biopsies conducted prior to the start of T-DXd treatment)","Describe the number of biopsies conducted prior to the start of T-DXd treatment.","Baseline, assessed for the past 10 years",{"measure":76,"description":77,"timeFrame":74},"Biopsy Patterns (the time from the last fresh biopsy to the start of T-DXd treatment, measured in months or years)","Describe the time from the last fresh biopsy to the start of T-DXd treatment.",{"measure":79,"description":80,"timeFrame":12},"Reasons for Discontinuation (rwTTNT1 and rwTTNT2)","Evaluate the reasons for discontinuation of T-DXd treatment and subsequent therapy due to disease progression, adverse events, or other reasons.",{"measure":82,"description":83,"timeFrame":12},"T-DXd Treatment Changes Over Time","Proportion of patients with dose changes, proportion of patients with dose reductions, interruption(s), or treatment discontinuation",{"allocation":66,"interventionModel":66,"interventionModelDescription":66,"primaryPurpose":66,"observationalModel":85,"timePerspective":86,"maskingInfo":66},"COHORT","OTHER","EXPLORE Non-Interventional Study for HER2-low Breast Cancer Treatment with T-DXd\n\nBackground:\n\nHER2 is a prognostic marker in various cancers, including breast cancer (BC). Traditionally categorized as HER2-positive or HER2-negative, recent advancements with anti-HER2 ADCs, like trastuzumab deruxtecan (T-DXd), have shown benefits for HER2-low status BC. The DB-04 trial demonstrated significant survival benefits with T-DXd, leading to its EMA approval for HER2-low BC in January 2023.\n\nStudy Rationale:\n\nLimited real-world evidence exists for T-DXd in HER2-low BC, particularly in the Balkans. The EXPLORE study aims to fill this gap by collecting real-world data in Bulgaria and Slovenia.\n\nObjectives:\n\nPrimary Objective:\n\nDescribe real-world Time to Next Treatment (rwTTNT1) of T-DXd in HER2-low unresectable or metastatic BC (mBC).\n\nSecondary Objectives:\n\nDescribe pre-T-DXd treatment patterns at baseline. Describe patient demographics and clinical characteristics at baseline. Describe rwTTNT1 by prior therapy lines in the metastatic setting and by hormone receptor (HR) status.\n\nEvaluate real-world Time to Treatment Discontinuation (rwTTD1).\n\nExploratory Objectives:\n\nEvaluate real-world progression-free survival (rwPFS1). Characterize subsequent treatments and post-progression endpoints (rwTTNT2, rwTTD2, rwPFS2).\n\nDescribe biopsy patterns. Evaluate reasons for discontinuation (rwTTNT1 and rwTTNT2). Describe T-DXd treatment changes over time. No formal hypothesis is set.\n\nMethods:\n\nStudy Design:\n\nObservational, longitudinal, non-interventional study in Bulgaria and Slovenia. Patients with unresectable or mBC starting T-DXd within 30 days of enrolment. Data from hospital charts at routine visits.\n\nPopulation:\n\nAdults (≥18 years) with HER2-low mBC, initiating T-DXd independent of the study.\n\nExposure:\n\nT-DXd treatment details (dose, duration) and other therapies recorded. Recommended T-DXd dose: 5.4 mg\u002Fkg IV every 3 weeks.\n\nOutcomes:\n\nPrimary: Time from T-DXd initiation to subsequent therapy or death. Exploratory: Various survival measures, biopsy patterns, reasons for discontinuation, and treatment changes.\n\nSample Size:\n\nApproximately 135 patients (100 in Bulgaria, 35 in Slovenia).\n\nStatistical Analysis:\n\nDescriptive analyses for cohort characteristics. Kaplan-Meier method for time-to-event endpoints. Subgroup analyses by prior therapy lines and HR status.\n\nData Collection:\n\nData from paper or electronic health records. Single anonymized dataset via electronic case report forms (CRFs).","Study Population:\n\nCriteria:\n\nAge: Adult patients (≥18 years). Diagnosis: Confirmed diagnosis of unresectable or metastatic breast cancer (mBC).\n\nHER2 Status: Documented HER2-low status. Treatment Decision: Patients for whom the decision to initiate trastuzumab deruxtecan (T-DXd) treatment has been made independently and prior to enrolment in the study.\n\nEnrollment:\n\nTiming: Patients must be enrolled within 30 days before the administration of the first T-DXd infusion.\n\nConsent: Patients must provide written informed consent for data collection.",[90],{"type":91,"name":92,"description":93,"armGroupLabels":66,"otherNames":66},"DRUG","trastuzumab deruxtecan","T-DXd",[95],{"name":96,"role":97,"phone":98,"phoneExt":66,"email":99},"AstraZeneca Clinical Study Information Center, Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[101,122,137,151,160,165,175,180,185,196,201,215,223,238],{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Research Site","NOT_YET_RECRUITING","Panagyurishte","Pazardzhik","4500","Bulgaria","BG",{"type":110,"coordinates":111},"Point",[112,113],24.19021,42.49518,{"lat":113,"lon":112},[116,119],{"name":66,"role":97,"phone":117,"phoneExt":66,"email":118},"+359884 296 946","uni@unihospitalbg.bg",{"name":120,"role":121,"phone":66,"phoneExt":66,"email":66},"Rossitza Krasteva, Dr.","PRINCIPAL_INVESTIGATOR",{"facility":102,"status":123,"city":124,"state":66,"zip":125,"country":107,"countryCode":108,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"RECRUITING","Burgas","8000",{"type":110,"coordinates":127},[128,129],27.46886,42.50651,{"lat":129,"lon":128},[132,135],{"name":66,"role":97,"phone":133,"phoneExt":66,"email":134},"+35956 531068","odisp@abv.bg",{"name":136,"role":121,"phone":66,"phoneExt":66,"email":66},"Ivan Bivolarski, Dr.",{"facility":102,"status":103,"city":138,"state":66,"zip":139,"country":107,"countryCode":108,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Plovdiv","4004",{"type":110,"coordinates":141},[142,143],24.75001,42.15387,{"lat":143,"lon":142},[146,149],{"name":66,"role":97,"phone":147,"phoneExt":66,"email":148},"+35932277240","kocplovdiv@onkoplov.com",{"name":150,"role":121,"phone":66,"phoneExt":66,"email":66},"Ivan Tonev, Dr.",{"facility":102,"status":152,"city":153,"state":66,"zip":154,"country":107,"countryCode":108,"cosmosGeoPoint":155,"geoPoint":159,"contacts":66},"ACTIVE_NOT_RECRUITING","Sofia","1303",{"type":110,"coordinates":156},[157,158],23.32415,42.69751,{"lat":158,"lon":157},{"facility":102,"status":152,"city":153,"state":66,"zip":161,"country":107,"countryCode":108,"cosmosGeoPoint":162,"geoPoint":164,"contacts":66},"1330",{"type":110,"coordinates":163},[157,158],{"lat":158,"lon":157},{"facility":102,"status":103,"city":153,"state":66,"zip":166,"country":107,"countryCode":108,"cosmosGeoPoint":167,"geoPoint":169,"contacts":170},"1407",{"type":110,"coordinates":168},[157,158],{"lat":158,"lon":157},[171,173],{"name":66,"role":97,"phone":172,"phoneExt":66,"email":66},"+35924034000",{"name":174,"role":121,"phone":66,"phoneExt":66,"email":66},"Jeliazko Arabadjiev",{"facility":102,"status":152,"city":153,"state":66,"zip":176,"country":107,"countryCode":108,"cosmosGeoPoint":177,"geoPoint":179,"contacts":66},"1431",{"type":110,"coordinates":178},[157,158],{"lat":158,"lon":157},{"facility":102,"status":152,"city":153,"state":66,"zip":181,"country":107,"countryCode":108,"cosmosGeoPoint":182,"geoPoint":184,"contacts":66},"1527",{"type":110,"coordinates":183},[157,158],{"lat":158,"lon":157},{"facility":102,"status":103,"city":153,"state":66,"zip":186,"country":107,"countryCode":108,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"1618",{"type":110,"coordinates":188},[157,158],{"lat":158,"lon":157},[191,194],{"name":66,"role":97,"phone":192,"phoneExt":66,"email":193},"+3592 818 46 00","svsofia@mbal-sofia.com",{"name":195,"role":121,"phone":66,"phoneExt":66,"email":66},"Marchela Koleva, Dr.",{"facility":102,"status":152,"city":153,"state":66,"zip":197,"country":107,"countryCode":108,"cosmosGeoPoint":198,"geoPoint":200,"contacts":66},"1756",{"type":110,"coordinates":199},[157,158],{"lat":158,"lon":157},{"facility":102,"status":103,"city":202,"state":66,"zip":203,"country":107,"countryCode":108,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Stara Zagora","6003",{"type":110,"coordinates":205},[206,207],25.64262,42.43205,{"lat":207,"lon":206},[210,213],{"name":66,"role":97,"phone":211,"phoneExt":66,"email":212},"+35942614196","oncosz@abv.bg",{"name":214,"role":121,"phone":66,"phoneExt":66,"email":66},"Bozhidara Kostova, Dr.",{"facility":102,"status":152,"city":216,"state":66,"zip":217,"country":107,"countryCode":108,"cosmosGeoPoint":218,"geoPoint":222,"contacts":66},"Varna","9003",{"type":110,"coordinates":219},[220,221],27.91024,43.21912,{"lat":221,"lon":220},{"facility":102,"status":123,"city":224,"state":66,"zip":225,"country":226,"countryCode":227,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Ljubljana","1000","Slovenia","SI",{"type":110,"coordinates":229},[230,231],14.50513,46.05108,{"lat":231,"lon":230},[234,236],{"name":66,"role":97,"phone":66,"phoneExt":66,"email":235},"info@onko-i.si",{"name":237,"role":121,"phone":66,"phoneExt":66,"email":66},"Principal Investigator",{"facility":102,"status":123,"city":239,"state":66,"zip":240,"country":226,"countryCode":227,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Maribor","2000",{"type":110,"coordinates":242},[243,244],15.64593,46.55583,{"lat":244,"lon":243},[247,249],{"name":66,"role":97,"phone":66,"phoneExt":66,"email":248},"pisarna@ukc-mb.si",{"name":237,"role":121,"phone":66,"phoneExt":66,"email":66},{"type":251,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100571974","real-world-study-of-trastuzumab-deruxtecan-in-patients-with-unresectable-or-metastatic-her2-low-breast-cancer-100571974",false,"NCT06727227","Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer","REal-world Study of Trastuzumab deruXtecan in Patients With unresectabLe or Metastatic Breast Cancer Expressing HER2-lOw From BulgaRia and SlovEnia (EXPLORE)","EXPLORE","Inclusion Criteria:\n\n* Adult patient (age ≥18 years) with histological or cytological confirmed diagnosis of unresectable or mBC.\n* Documented HER2-low status (IHC1+, IHC2+\u002FISH-) in patients who have received prior chemotherapy in the metastatic setting or documented HER2-low status (IHC 1+, IHC 2+\u002FISH-) in patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.\n* Recent prior decision to initiate therapy of T-DXd per SmPC (up to 30 days). Documentation confirming this decision will be required and collected.\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* History of other primary malignancies in 2 years prior to unresectable or mBC diagnosis.\n* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.\n* HER2-low status patients who have previously documented HER2+ status in the same tumor.","ALL","18 Years",{"count":263,"type":264},138,"ESTIMATED","OBSERVATIONAL","A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia",[268],"Breast Cancer","2026-08-14",{"date":271,"type":272},"2026-08-17","ACTUAL",{"date":274,"type":272},"2025-01-29",{"date":276,"type":264},"2027-10-31",{"name":5,"class":6},14]