Using Fenofibrate to Prevent Heart Damage from Doxorubicin in Breast Cancer Patients

Clinical Study to Evaluate the Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients

This study is testing if fenofibrate can help protect the hearts of breast cancer patients from damage caused by the chemotherapy drug doxorubicin.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tanta University (other)
• Drugs / interventions: Trastuzumab, doxorubicin
• Locations: 1 site (Tanta, Elgharbya)
• Trial ID: NCT06155331 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of fenofibrate in reducing cardiac toxicity caused by doxorubicin in patients with stage II and III breast cancer. Doxorubicin is a common chemotherapy drug that can lead to serious heart issues, and fenofibrate, a medication typically used for cholesterol management, may help mitigate these effects. The trial will involve administering fenofibrate alongside standard chemotherapy and monitoring patients for cardiac health. The goal is to determine if fenofibrate can provide protective benefits against heart damage during cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with biopsy-confirmed stage II or III breast cancer and adequate organ function.

Not a fit: Patients with prior exposure to anthracyclines or severe cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of heart damage in breast cancer patients undergoing chemotherapy.

How similar studies have performed: While the use of fenofibrate in this context is novel, other studies have explored cardioprotective strategies during chemotherapy, indicating potential for success.

Eligibility 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.

Where this trial is running

Tanta, Elgharbya

• Hagar Dewidar — Tanta, Elgharbya, Egypt (RECRUITING)

Study contacts

• Principal investigator: Hagar Dewidar, Instructor — Tanta University
• Study coordinator: Hagar Dewidar, Instructor

Conditions: Breast Cancer Stage 2 and 3, Breast cancer , Doxorubicin, Fenofibrate , Cardiotoxicity