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Clinical trial

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

ID
Name
rosuva2020
Description
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.
Trial arms
Trial start
2020-09-15
Estimated PCD
2023-09-15
Trial end
2023-09-15
Status
Completed
Phase
Early phase I
Treatment
Rosuvastatin 20mg
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).
Arms:
rosuvastatin-group
Size
50
Primary endpoint
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
6 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

1 product

2 indications

Organization
Tanta University
Product
Rosuvastatin
Indication
Chemotherapy-induced Cardiotoxicity
Indication
Breast Cancer