๐ฌIn plain words
What the trial is, and whether it could suit you
This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 years old.
* Chemo-naรฏve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients intended to receive at least 4 cycles of doxorubicin or more.
* Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
* Echocardiographic LVEF โฅ55%.
* Adequate baseline hematologic values (absolute neutrophilic count โฅ 1.5 ร109/L, platelet count โฅ 90 ร 109/L and hemoglobin level โฅ 10 g/dl).
* Patients with adequate liver function and adequate renal function.
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Age \<18 years old and \>65 years old.
* Patients with prior exposure to anthracyclines within the last 6 months.
* Patients with evidence of metastasis at initial assessment.
* Treatment with any SGLT-2 inhibitors for 6 months prior to the screening.
* Patients taking any other cardioprotective medications.
* Pregnancy and breast feeding.
* Alcohol abuse.
* History of heart failure or LVEF \<50%.
* Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
* Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.
Medical Research Institute
Alexandria, Egypt
๐ค 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.