protocolSection identificationModule nctId: NCT06304857, orgStudyIdInfo id: 2022/ABM/01/00039, secondaryIdInfos id: 2023-506631-15-00, type: OTHER, domain: EUCT, briefTitle: CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL, acronym: PROTECTAA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: 4th Military Clinical Hospital with Polyclinic, Poland, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Breast Cancer, conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 188, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months., secondaryOutcomes measure: Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months., secondaryOutcomes measure: Change in left ventricular ejection fraction at 6 and 12 months., secondaryOutcomes measure: Change in left ventricular diastolic function at 6 and 12 months., secondaryOutcomes measure: Change in Troponin I after 6 and 12 months., secondaryOutcomes measure: Change in NTproBNP levels at 6 and 12 months., secondaryOutcomes measure: Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire., secondaryOutcomes measure: Occurrence of death from any cause., secondaryOutcomes measure: Composite endpoint of cardiovascular events., secondaryOutcomes measure: Occurrence of death from any cardiovascular reasons., secondaryOutcomes measure: Occurrence of non-fatal myocardial infarction., secondaryOutcomes measure: Occurrence of non-fatal stroke., secondaryOutcomes measure: Occurrence of hypoglycaemia., secondaryOutcomes measure: Occurrence of ionic disorders., secondaryOutcomes measure: Occurrence of renal failure., secondaryOutcomes measure: Occurrence of hypersensitivity to investigated drug., secondaryOutcomes measure: Occurrence of allergic reactions., secondaryOutcomes measure: Occurrence of infection., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 4th Military Clinical Hospital with Polyclinic, status: RECRUITING, city: Wrocław, state: Dolnośląskie, zip: 50-981, country: Poland, contacts name: Bartosz Krakowiak, PhD, MD, role: CONTACT, phone: +48 261 660 234, email: bkrakowiak@4wsk.pl, geoPoint lat: 51.1, lon: 17.03333, locations facility: Lower Silesian Centre for Oncology, Lung Diseases and Hematology, status: RECRUITING, city: Wrocław, state: Dolnośląskie, zip: 53-413, country: Poland, contacts name: Rafał Matkowski, PhD, MD, role: CONTACT, geoPoint lat: 51.1, lon: 17.03333, locations facility: Military Medical Institute, status: NOT_YET_RECRUITING, city: Warsaw, state: Mazowieckie, zip: 04-141, country: Poland, contacts name: Paweł Krzesiński, PhD, MD, role: CONTACT, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False