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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Chemotherapy-induced Cardiotoxicity
• Intervention / Treatment: Drug: Rosuvastatin 20mg

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • The Department of Clinical Oncology, Tanta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control-group; This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.
Active Comparator: rosuvastatin-group; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: khlood m. kettana, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Breast Neoplasms; Cardiotoxicity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: rosuva2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No