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).

and planned anthracycline treatment within 60 days., on stage I-III, Patients with invasive breast cancer

Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction, CTRCD):, the appearance of heart failure symptoms (NYHA class I-IV) due to an impairment of heart function or structure within 12 months; or, asymptomatic decrease in left ventricular ejection fraction > 10% after 12 months; or, asymptomatic decrease in left ventricular ejection fraction < 10% but up to 40-49% after 12 months; or, asymptomatic decrease in global left ventricular longitudinal strain >15% after 12 months; or, asymptomatic increase in biomarkers (troponin I > upper reference limit (99th centile) and increase of at least 30% from pre-treatment concentration or NTproBNP > 125 pg/ml and increase of at least 30% from baseline) after 12 months.

Secondary Composite Efficacy Endpoint:, 1. emergence of heart failure symptoms (NYHA class I-IV) due to impaired cardiac function or structure at 6 months; or, 2. decrease LVEF > 10% after 6 months; or, 3. decrease LVEF < 10% but to a value of 40-49% after 6 months; or, 4. a decrease in global longitudinal strain of > 15% after 6 months; or, 5. asymptomatic increase in biomarkers (troponin I > upper reference limit (99th centile) and an increase of at least 30% from pre-treatment concentration or NTproBNP > 125pg/ml and an increase of at least 30% from baseline) after 6 months., Secondary Additional Endpoints:, 1. change in left ventricular ejection fraction at 6 and 12 months;, 2. change in left ventricular diastolic function, assessed as the ratio of E/E', i.e. maximum mitral annular inflow velocity during the rapid ventricular filling phase, to maximum mitral annular motion velocity by tissue Doppler during the rapid ventricular filling phase;, 3. change in Troponin I after 6 and 12 months;, 4. change in NTproBNP levels at 6 and 12 months;, 5. change in quality of life assessment at 6 and 12 months., Secondary Endpoints (Safety):, 1. death from any cause;, 2. composite endpoint of cardiovascular events (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke);, 3. death from any cardiovascular reasons;, 4. non-fatal myocardial infarction;, 5. non-fatal stroke;, 6. occurrence of hypoglycaemia;, 7. occurrence of ionic disorders;, 8. progression of renal failure;, 9. hypersensitivity to investigated drug;, 10. allergic reactions;, 11. infection., 12. any other AEs, evaluated due to type, frequency and severity.

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