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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338723
• Other study ID #: rosuva2020
• Status: Completed
• Phase: Phase 3
• Start date: September 15, 2020
• Est. completion date: September 15, 2023

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Egypt	The Department of Clinical Oncology, Tanta University Hospital	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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