Status:
COMPLETED
Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
Lead Sponsor:
Tanta University
Conditions:
Chemotherapy-induced Cardiotoxicity
Breast Cancer
Eligibility:
FEMALE
25-75 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05338723
Start Date
September 15 2020
End Date
September 15 2023
Last Update
February 28 2024
Active Locations (1)
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1
The Department of Clinical Oncology, Tanta University Hospital
Tanta, Egypt