Recruiting

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

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.

ClinicalTrials.gov IDNCT06304857
PhasePHASE3
Enrollment188
Sponsor4th Military Clinical Hospital with Polyclinic, Poland
Age18 Years – 80 Years
SexALL
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Conditions studied

Breast Cancer, Heart Failure

About this study

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.

Interventions

Primary outcomes

Eligibility information

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 ≥ 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 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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.