[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612487":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":41,"studyPopulation":16,"armGroups":42,"interventions":55,"overallOfficials":16,"centralContacts":16,"locations":65,"responsibleParty":153,"collaborators":16,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":16,"enrollmentInfo":167,"targetDuration":16,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":179,"overallStatus":189,"whyStopped":16,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Shiraz University of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"CTRCD (cancer treatment-related cardiac dysfunction)","CTRCD is defined as a reduction of ≥10 percentage points in LVEF by echocardiography to \\\u003C53% or a \\>15% relative decline in global longitudinal strain (GLS) compared with baseline strain.","12 months after randomization",[14,18,20,22,24],{"measure":15,"description":16,"timeFrame":17},"changes in LVEF",null,"3, 6, and 12 months after randomization",{"measure":19,"description":16,"timeFrame":17},"changes in Global Longitudinal Strain (GLS)",{"measure":21,"description":16,"timeFrame":17},"changes in Troponin level",{"measure":23,"description":16,"timeFrame":17},"changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) level",{"measure":25,"description":16,"timeFrame":17},"changes in High-sensitivity C-reactive Protein (hsCRP) level",[27],{"measure":28,"description":16,"timeFrame":12},"major adverse cardiovascular events (MACE)",{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":16,"timePerspective":16,"maskingInfo":34},"RANDOMIZED","PARALLEL","multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo-controlled clinical trial","PREVENTION",{"masking":35,"maskingDescription":16,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Introduction: Anthracycline-induced cardiotoxicity significantly threatens the long-term cardiac health of breast cancer patients undergoing chemotherapy. Statins have shown potential cardioprotective effects without compromising cancer treatment efficacy. The ROSUBREAST study aims to evaluate the efficacy of rosuvastatin in preventing CTRCD in breast cancer patients receiving anthracycline-based chemotherapy. Methods: This multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo controlled clinical trial will be conducted across seven oncocardiology centers in Iran. A total of 400 participants will be enrolled and will be randomly assigned in a 1:1 ratio to receive either rosuvastatin (20 mg daily) or no intervention for 12 months. The primary endpoint is the incidence of CTRCD, defined as a ≥10% reduction in left ventricular ejection fraction (LVEF) to below the lower normal limit (53%). Secondary endpoints include changes in Global Longitudinal Strain (GLS), biomarkers (Troponin, NT-proBNP, hsCRP), and development of heart failure (HF). Ancillary endpoints are quality-of-life assessments and adverse effects of treatment. Conclusion: The ROSUBREAST study seeks to provide evidence on the cardioprotective role of rosuvastatin in breast cancer patients undergoing anthracycline-based chemotherapy, potentially informing clinical guidelines and improving patient outcomes.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Intervention","ACTIVE_COMPARATOR","Consumption of 20 milligrams rosuvastatin daily",[48],"Drug: Rosuvastatin 20 mg\u002Fday",{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo","PLACEBO_COMPARATOR","Placebo (placebo tablets similar to rosuvastatin)",[54],"Drug: Placebo tablets similar to rosuvastatin 20mg tablets",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":16},"DRUG","Rosuvastatin 20 mg\u002Fday","Consumption of rosuvastatin 20mg tablets every day",[44],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":16},"Placebo tablets similar to rosuvastatin 20mg tablets","consumption of placebo tablets similar to rosuvastatin 20mg",[50],[66,85,95,109,123,133,143],{"facility":67,"status":16,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Motahari Breast Cancer Clinic","Shiraz","Fars","71344-1864","Iran","IR",{"type":74,"coordinates":75},"Point",[76,77],52.53113,29.61031,{"lat":77,"lon":76},[80],{"name":81,"role":82,"phone":16,"phoneExt":83,"email":84},"Armin Attar, Associate Professor","CONTACT","+98 71 3612 10","attar_armin@yahoo.com",{"facility":86,"status":16,"city":68,"state":69,"zip":16,"country":71,"countryCode":72,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Kowsar Hospital, Fars Heart Foundation",{"type":74,"coordinates":88},[76,77],{"lat":77,"lon":76},[91],{"name":92,"role":82,"phone":93,"phoneExt":16,"email":94},"Masoud Sayad","+98 71 3614 1000","masoud.sayad@yahoo.com",{"facility":96,"status":16,"city":97,"state":98,"zip":16,"country":71,"countryCode":72,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Toba Oncology Department, Mazandaran University of Medical Sciences","Sari","Mazandaran",{"type":74,"coordinates":100},[101,102],53.06009,36.56332,{"lat":102,"lon":101},[105],{"name":106,"role":82,"phone":107,"phoneExt":16,"email":108},"Maryam Nabati","+98 11 3304 4000","dr.mr.nabati@gmail.com",{"facility":110,"status":16,"city":111,"state":112,"zip":16,"country":71,"countryCode":72,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Modarres Hospital, Shahid Beheshti University of Medical Sciences","Tehran","Tehran Province",{"type":74,"coordinates":114},[115,116],51.42151,35.69439,{"lat":116,"lon":115},[119],{"name":120,"role":82,"phone":121,"phoneExt":16,"email":122},"Shabnam Kazemloo","+98 21 23515","kazemloo.shabnam@sbmu.ac.ir",{"facility":124,"status":16,"city":111,"state":112,"zip":16,"country":71,"countryCode":72,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Rajaee Hospital, Iran University of Medical Sciences",{"type":74,"coordinates":126},[115,116],{"lat":116,"lon":115},[129],{"name":130,"role":82,"phone":131,"phoneExt":16,"email":132},"Azin Alizadehasl","+98 21 3455 2001","alizadeasl@gmail.com",{"facility":134,"status":16,"city":111,"state":112,"zip":16,"country":71,"countryCode":72,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Sina Hospital, Tehran University of Medical Sciences",{"type":74,"coordinates":136},[115,116],{"lat":116,"lon":115},[139],{"name":140,"role":82,"phone":141,"phoneExt":16,"email":142},"Zahra Shajari","+98 21 6634 8587","adz.shajari@gmail.com",{"facility":144,"status":16,"city":111,"state":112,"zip":16,"country":71,"countryCode":72,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Taleghani Hospital, Shahid Beheshti University of Medical Sciences",{"type":74,"coordinates":146},[115,116],{"lat":116,"lon":115},[149],{"name":150,"role":82,"phone":151,"phoneExt":16,"email":152},"Alireza Farzaei","+98 21 2243 2566","alirezafarzaei@gmail.com",{"type":154,"investigatorFullName":155,"investigatorTitle":156,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Armin Attar","Prof. Armin Attar","100612487","phase-4-rosuvastatin-for-prevention-of-anthracycline-induced-cardiac-dysfunction-in-breast-cancer-patients-100612487",false,"NCT07254221","Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients","Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy","ROSUBREAST","Inclusion Criteria:\n\n* Female individuals with ≥18 years of age\n* Documented breast cancer diagnosis based on imaging and pathology findings\n* Scheduled to receive the first time anthracycline-based chemotherapy\n\nExclusion Criteria:\n\n* Baseline LVEF \\\u003C 50%\n* Prior Statin use or Statin use is indicated based on guidelines\n* history of congestive heart failure (CHF) or cardiomyopathy\n* Pregnancy or breastfeeding\n* Unable to provide informed consent\n* Unexplained persistent elevation of transaminases (\\>3 times upper limits of normal)\n* Concomitant use of oral cyclosporine\n* Metastatic invasion of cancer to other organs\n* Previous cycles of chemotherapy\n* Any contraindication for statin use","FEMALE","18 Years",{"count":168,"type":169},400,"ESTIMATED","INTERVENTIONAL",[172],"PHASE4","This study, called \"ROSUBREAST\", is a multicenter, double-blind, randomized clinical trial evaluating whether rosuvastatin (20 mg daily) can protect the heart in women with breast cancer receiving anthracycline-based chemotherapy. A total of 400 participants will be randomly assigned to receive either rosuvastatin or placebo for 12 months. The main goal is to determine whether rosuvastatin can prevent cancer treatment-related cardiac dysfunction (CTRCD), defined as a significant drop in heart pumping function. The study will also assess changes in cardiac strain, blood biomarkers, symptoms of heart failure, quality of life, and possible side effects.",[175,176,177,178],"Anthracycline-induced Cardiac Toxicity","Breast Cancer","Anthracycline Related Cardiotoxicity in Breast Cancer","Anthracycline-induced Cardiotoxicity",[180,181,182,183,184,185,186,187,188],"Breast cancer","rosuvastatin","statin therapy,","cancer-related treatment cardiac dysfunction","anthracycline induced cardiomyopathy","cardiac dysfunction","cardiotoxicity","chemotherapy","anthracycline","NOT_YET_RECRUITING","2025-12-03",{"date":192,"type":193},"2025-12-10","ACTUAL",{"date":195,"type":169},"2026-02-01",{"date":197,"type":169},"2028-04-21",{"name":5,"class":6},7]