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

RecruitingPhase 3Ages 18 Years - 80 YearsAll4th Military Clinical Hospital with Polyclinic, Pโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment. * Recognised heart failure or symptoms which, in the opinion of the investigator may be 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 fibrillation regardless 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 the discretion of the investigator). * BMI \> 40 kg/m2. * Diagnosed type 1 or type 2 diabetes or fasting glucose โ‰ฅ 126 mg/dl or HbA1C โ‰ฅ 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 12 months. * Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit. * Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit. * eGFR \< 25 ml/min/1.73m2 according to CKD EPI. * Life expectancy \< 12 months or cancer disease stage IV according to the TNM classification. * Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm. * 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 impossible to fulfill the requirements for participation in this study.
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What it tests

  • Dapagliflozin
  • Placebo
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Where

3 sites
4th Military Clinical Hospital with Polyclinic
Wroclaw, Poland
Lower Silesian Centre for Oncology, Lung Diseases and Hematology
Wroclaw, Poland
Military Medical Institute
Warsaw, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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