nctId: NCT06341842 id: EudraCT 2022-003377-28 briefTitle: Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity acronym: PROTECT overallStatus: RECRUITING date: 2023-10-19 date: 2025-04-19 date: 2025-04-19 date: 2024-04-02 date: 2024-04-02 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER 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. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 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 masking: NONE count: 316 type: ESTIMATED name: Dapagliflozin 10mg Tab 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. 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 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) measure: Change from baseline in end diastolic and systolic left ventricular volumes and in left atrial volume during 18 months measure: Change from baseline of at least of one grade of diastolic disfunction (according to ESC guidelines during 18 months. measure: Change in plasma levels of the bio-humoral marker NT-pro-BNP between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker hsTNI between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker CKD-EPI eGFR between baseline and follow-up measure: Change in plasma levels of the bio-humoral marker hsCRP between baseline and follow-up measure: Safety Outcomes: TEAE incidence measure: Toxicity: renal failure evaluation. measure: Toxicity: hypoglycaemia evaluation measure: Tolerability: genito-urinary tract infections measure: Tolerability: symptomatic hypotension measure: Quality of Life questionaire: EQ-5D-5L sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Gianpiero Rizzo, Oncologist role: CONTACT phone: +390382502094 email: g.rizzo@smatteo.pv.it name: Alessandra Greco, Cardiologist role: CONTACT phone: +390382501326 email: a.greco@smatteo.pv.it lat: 45.19205 lon: 9.15917 hasResults: False