About this trial
1\. Background and Rationale Breast cancer is one of the most common malignancies affecting women worldwide and represents a major health burden in Egypt. Anthracyclines, particularly doxorubicin, remain an important component of several breast cancer chemotherapy regimens. However, their clinical utility is limited by the potential development of anthracycline-induced cardiotoxicity.
Doxorubicin-induced cardiac injury is multifactorial and involves oxidative stress, mitochondrial dysfunction, disturbances in myocardial energy metabolism, apoptosis, inflammation, and progressive myocardial structural damage. Cardiac injury may initially occur without symptoms or an obvious reduction in left ventricular ejection fraction (LVEF). Consequently, identification of early myocardial injury is important because intervention before clinically apparent heart failure may potentially reduce progression to overt cardiac dysfunction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Female patients aged ≥18 years. 2. Egyptian nationality. 3. Histologically confirmed breast cancer. 4. Planned treatment with a doxorubicin-containing chemotherapy regimen. 5. Expected cumulative doxorubicin dose of approximately ≥240 mg/m², or another prespecified protocol threshold.
Disqualifiers
1. Previous exposure to anthracyclines. 2. Known heart failure. 3. Baseline LVEF <53%. 4. Previous myocardial infarction or significant coronary artery disease. 5. Significant valvular heart disease. 6. Clinically significant arrhythmia. 7. Uncontrolled hypertension. 8. Significant renal impairment according to a predefined eGFR threshold. 9. Significant hepatic impairment. 10. Active infection or another condition likely to affect troponin interpretation.
Trial design
Parallel
Treatments tested in this trial
Doxorubicin
DrugStandard oncologic care without cardioprotective intervention followed concurrently for 24 weeks
Empaglifloz 5 mg orally once daily
DrugInitiated 1 week prior to chemotherapy; continued for 24 weeks
Treatment groups
Trial outcomes
Primary outcomes
Cardiac Troponin Assessment
The principal biochemical endpoint will be defined as: Cardiac troponin concentration \>99th percentile upper reference limit of the laboratory assay. Acute myocardial injury will be characterized by a dynamic rise and/or fall in troponin when clinically appropriate.
Sponsors and contacts
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