Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients

Study Overview
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Brief Summary
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This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.

Official Title
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Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients

Conditions
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Chemotherapy-induced Cardiotoxicity, Breast Cancer

Intervention / Treatment
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* Drug: Rosuvastatin 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 25-75 years old. Gender: female Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%. Patients with normal renal and hematological functions. Alanine amino transferase (ALT ≤ 3 times ULN). Exclusion Criteria: Pregnant or lactating females. Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2 Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)<50%. Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy. Alanine amino transferase (ALT > 3 times ULN). Patients already taking statins or other lipid lowering therapy. Patients with a known hypersensitivity to any of the used drugs.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control-group<br>This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy. | |
| Active Comparator: rosuvastatin-group<br>This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). | Drug: Rosuvastatin 20mg<br>* 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography | Patients will undergo transthoracic echocardiography 24 hours prior to the initiation of chemotherapy, after 3 months and after 6 months to detect change in LVEF | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of serum level of High sensitivity troponin I (hs-TnI). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI). | 6 months | 
| change of serum level of Myeloperoxidase (MPO). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO). | 6 months | 
| change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6). | 6 months | 
| change of serum level of Liver function test (ALT). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT). | 6 months |