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

Prior treatment

• Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.
• Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.
• Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.

Other illness

• Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.
• Severe valvular heart disease.
• A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).
• A history of stroke.
• Pulmonary hypertension.
• Life expectancy \< 12 months or cancer disease stage IV according to the TNM classification.
• 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 impossible to fulfill the requirements for participation in this study.

Lab values

• Left ventricular ejection fraction \< 50% at the time of the screening.
• Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol).
• eGFR \< 25 ml/min/1.73m2 according to CKD EPI.
• Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.
• Anemia with Hemoglobin \< 9 g/dl.

Other

• Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.
• Uncontrolled arterial pressure or systolic pressure \< 80 mmHg at screening (at the discretion of the investigator).
• BMI \> 40 kg/m2.
• Pregnancy or breastfeeding.
• Lack of compliance to use highly effective method of birth control.
• Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.

• Age \> 18 years and \< 80 years.
• Diagnosis of invasive breast cancer \[stage I-III\] and planned anthracycline treatment within 60 days.
• Signed Informed Consent to participate in the study.