protocolSection identificationModule nctId: NCT06341842, orgStudyIdInfo id: EudraCT 2022-003377-28, briefTitle: Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity, acronym: PROTECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-19, primaryCompletionDateStruct date: 2025-04-19, completionDateStruct date: 2025-04-19, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Investigator initiated Phase II "proof of concept", multicentre, randomized 1:1, open label, parallel-groups study, designed to evaluate if dapagliflozin reduces chemotherapy induced cardiotoxicity in participants with breast cancer treated with (neo-) adjuvant Anthracycline-based chemotherapy +/- trastuzumab., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 316, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, outcomesModule primaryOutcomes measure: Assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up., secondaryOutcomes measure: Difference in severe, moderate and mild asymptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ and with or without the use of any of ACEi, angiotensin receptor blockers, or b-blockers, secondaryOutcomes measure: Difference in symptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ (subgroup analysis), secondaryOutcomes measure: Change from baseline in end diastolic and systolic left ventricular volumes and in left atrial volume during 18 months, secondaryOutcomes measure: Change from baseline of at least of one grade of diastolic disfunction (according to ESC guidelines during 18 months., secondaryOutcomes measure: Change in plasma levels of the bio-humoral marker NT-pro-BNP between baseline and follow-up, secondaryOutcomes measure: Change in plasma levels of the bio-humoral marker hsTNI between baseline and follow-up, secondaryOutcomes measure: Change in plasma levels of the bio-humoral marker CKD-EPI eGFR between baseline and follow-up, secondaryOutcomes measure: Change in plasma levels of the bio-humoral marker hsCRP between baseline and follow-up, otherOutcomes measure: Safety Outcomes: TEAE incidence, otherOutcomes measure: Toxicity: renal failure evaluation., otherOutcomes measure: Toxicity: hypoglycaemia evaluation, otherOutcomes measure: Tolerability: genito-urinary tract infections, otherOutcomes measure: Tolerability: symptomatic hypotension, otherOutcomes measure: Quality of Life questionaire: EQ-5D-5L, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Gianpiero Rizzo, Oncologist, role: CONTACT, phone: +390382502094, email: g.rizzo@smatteo.pv.it, contacts name: Alessandra Greco, Cardiologist, role: CONTACT, phone: +390382501326, email: a.greco@smatteo.pv.it, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False