[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539516":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":81,"collaborators":31,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":31,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"4th Military Clinical Hospital with Polyclinic, Poland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapagliflozin","EXPERIMENTAL","Dapagliflozin 10 mg tablet orally once daily for 12 months",[13],"Drug: Dapagliflozin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo tablet matching dapagliflozin orally once daily for 12 months",[19],"Drug: Placebo",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","10 mg tablet q.d",[9],[26,27],"Farxiga","Forxiga",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"tablet matching dapagliflozin 10 mg q.d",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Waldemar Banasiak, PhD, MD","4th Military Clinical Hospital with Polyclinic","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Bartosz Krakowiak, PhD, MD","CONTACT","+48 261 660 234","bkrakowiak@4wsk.pl",[44,59,68],{"facility":35,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Wroclaw","Lower Silesian Voivodeship","50-981","Poland","PL",{"type":52,"coordinates":53},"Point",[54,55],17.03006,51.10286,{"lat":55,"lon":54},[58],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},{"facility":60,"status":45,"city":46,"state":47,"zip":61,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Lower Silesian Centre for Oncology, Lung Diseases and Hematology","53-413",{"type":52,"coordinates":63},[54,55],{"lat":55,"lon":54},[66],{"name":67,"role":40,"phone":31,"phoneExt":31,"email":31},"Rafał Matkowski, PhD, MD",{"facility":69,"status":45,"city":70,"state":71,"zip":72,"country":49,"countryCode":50,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Military Medical Institute","Warsaw","Masovian Voivodeship","04-141",{"type":52,"coordinates":74},[75,76],21.01178,52.22977,{"lat":76,"lon":75},[79],{"name":80,"role":40,"phone":31,"phoneExt":31,"email":31},"Paweł Krzesiński, PhD, MD",{"type":82,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100539516","phase-3-cardioprotection-with-dapagliflozin-in-breast-cancer-patients-treated-with-anthracycline---protectaa-trial-100539516",false,"NCT06304857","CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL","A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy","PROTECTAA","Inclusion Criteria:\n\n* Age \\> 18 years and \\\u003C 80 years.\n* Diagnosis of invasive breast cancer \\[stage I-III\\] and planned anthracycline treatment within 60 days.\n* Signed Informed Consent to participate in the study.\n\nExclusion Criteria:\n\n* Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.\n* Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.\n* Left ventricular ejection fraction \\\u003C 50% at the time of the screening.\n* Severe valvular heart disease.\n* A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).\n* A history of stroke.\n* Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.\n* Pulmonary hypertension.\n* Uncontrolled arterial pressure or systolic pressure \\\u003C 80 mmHg at screening (at the discretion of the investigator).\n* BMI \\> 40 kg\u002Fm2.\n* Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg\u002Fdl or HbA1C ≥ 6,5% (48 mmol\u002Fmol).\n* Pregnancy or breastfeeding.\n* Lack of compliance to use highly effective method of birth control.\n* Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.\n* Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.\n* Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.\n* eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2 according to CKD EPI.\n* Life expectancy \\\u003C 12 months or cancer disease stage IV according to the TNM classification.\n* Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.\n* Anemia with Hemoglobin \\\u003C 9 g\u002Fdl.\n* Kidney failure \\> G2 (according to KDIGO classification).\n* Liver disorders, Child-Pugh score \\> 4.\n* Known, active infections with HIV, HBV, HCV, tuberculosis.\n* Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.","ALL","18 Years","80 Years",{"count":95,"type":96},188,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.",[102,103],"Breast Cancer","Heart Failure",[105,106,107,108],"breast cancer","heart failure","ejection fraction","anthracyclines","2024-12-02",{"date":111,"type":112},"2024-12-04","ACTUAL",{"date":114,"type":112},"2024-04-15",{"date":116,"type":96},"2027-12-31",{"name":5,"class":6},3]