Status:
COMPLETED
Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Lead Sponsor:
Tanta University
Conditions:
Breast Cancer Stage 2 and 3
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This study aims at evaluating the possible safety and efficacy of fenofibrate in attenuating doxorubicin related cardiac toxicity in breast cancer patients.
Detailed Description
Breast cancer represents the most frequently diagnosed malignancy and the second most common cause of cancer death worldwide (Sung et al., 2021). In Egypt, breast cancer is the most common malignancy ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Patients with biopsy confirmed diagnosis breast cancer and with stage II and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
- Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
- Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
- Patients with adequate liver function (serum bilirubin \< 1.2 mg/dl) and adequate renal function (serum creatinine \< 1.5 mg/d).
Exclusion
- Patients with prior exposure to anthracyclines in the last 6 months.
- Patients with evidence of metastasis at the initial assessment.
- Concomitant use of antioxidant vitamins (vitamin A, C, E).
- Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias and left ventricular ejection fraction \<50%).
- Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).
- Patients with conditions associated with oxidative stress (smoking, tuberculosis, comorbid obesity).
- Patients who are candidates for monoclonal antibodies such as Trastuzumab and other targeted therapy (HER2 positive patients).
- Patients with active liver disease (cirrhosis, fatty liver, hepatitis C, etc..).
- Patients with myopathy.
- Patients with renal impairment, including those with end-stage renal disease and those receiving dialysis.
- Pregnant and breast feeding women.
- Known allergy to the fenofibrates.
- Concurrent use of statin, colchicine, ciprofibrate, idelalisib, ivacaftor, aspirin low strength, clopidogrel, warfarin, enzyme inducers (phenytoin, phenobarbitone, carbamazepine,…), enzyme inhibitors (allopurinol, MAOI, SSRI,…), drugs with high plasma protein binding capacity (sulfonamides, valproate, oral hypoglycemic, warfarin,…) in order to avoid potential pharmacodynamics and pharmacokinetic drug interactions.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06155331
Start Date
December 1 2023
End Date
January 1 2025
Last Update
August 19 2025
Active Locations (1)
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1
Hagar Dewidar
Tanta, Elgharbya, Egypt, 31527