CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

Inclusion Criteria:

• Age > 18 years and < 80 years.

• Diagnosis of invasive breast cancer [stage I-III] and planned anthracyclinetreatment within 60 days.

• Signed Informed Consent to participate in the study.

Exclusion Criteria:

• Urinary tract infection with the need for treatment with an antibiotic 48 hoursbefore the scheduled start of anthracycline treatment.

• Recognised heart failure or symptoms which, in the opinion of the investigator maybe a symptom of undiagnosed heart failure.

• Left ventricular ejection fraction < 50% at the time of the screening.

• Severe valvular heart disease.

• A history of clinically significant arrhythmia, including atrial fibrillationregardless of type (at discretion of the investigator).

• A history of stroke.

• Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g.amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.

• Pulmonary hypertension.

• Uncontrolled arterial pressure or systolic pressure < 80 mmHg at screening (at thediscretion of the investigator).

• BMI > 40 kg/m2.

• Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol).

• Pregnancy or breastfeeding.

• Lack of compliance to use highly effective method of birth control.

• Expected or possible treatment with epirubicin or liposomal doxorubicin within 12months.

• Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 monthsbefore the screening visit.

• Taking semaglutide, liraglutide and metformin during the 30 days preceding thescreening visit.

• eGFR < 25 ml/min/1.73m2 according to CKD EPI.

• Life expectancy < 12 months or cancer disease stage IV according to the TNMclassification.

• Alanine transaminase or aspartate transaminase levels above 2.5 times the localnorm.

• Anemia with Hemoglobin < 9 g/dl.

• Kidney failure > G2 (according to KDIGO classification).

• Liver disorders, Child-Pugh score > 4.

• Known, active infections with HIV, HBV, HCV, tuberculosis.

• Any other condition which, in the opinion of the investigator, makes it impossibleto fulfill the requirements for participation in this study.