Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims at evaluating the possible safety and efficacy of fenofibrate in attenuating doxorubicin related cardiac toxicity in breast cancer patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Cyclophosphamide; Doxorubicin; Fenofibrate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.