The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients

June 22, 2026 updated by: Damanhour University

The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients Treated With Doxorubicin-based Chemotherapy

the study aims to evaluate the cardioprotective effect of atorvastatin in breast cancer female patients treated with doxorubicin based chemotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

female patients with newly diagnosed breast cancer, who are candidates for AC protocol will be recruited from Damanhour oncology center.

All enrolled patients will be randomly assigned into 2 arms:

  • Control arm : will receive AC regimen only (doxorubicin 60 mg/m² IV + cyclophosphamide 600 mg/m² IV) for 4 cycles every 21 days.
  • Atorvastatin arm : will receive AC regimen mentioned above + atorvastatin 40 mg orally once daily for 3 months.

All patients will be submitted to:

  • Full patient history and clinical examination.
  • Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).
  • Echocardiography also will be obtained at the time of admission.
  • Serum samples will be collected from patients at the time of admission for measuring the cardiac biomarkers in addition to serum cholesterol level.

All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 8. Measuring outcome: The primary outcome is the change of serum levels of the measured cardiac biomarkers after 4 cycles of AC regimen.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Damanhour
      • Beheira, Damanhour, Egypt, 22511
        • Damanhour university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Women with newly diagnosed breast cancer and ≥ 18 years old.
  2. Naive to chemotherapy.
  3. Left ventricular ejection fraction (LVEF) > 55%.

Exclusion Criteria:

  1. Concurrent administration of any other cholesterol-lowering therapy.
  2. Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range)
  3. Evidence of renal dysfunction (creatinine level more than three times the upper limit of the normal range).
  4. Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle or liver disease.
  5. Concurrent administration of potent CYP3A4-inhibitors.
  6. Pregnancy or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control arm
Experimental: atorvastatin arm
Drug: Atorvastatin
atorvastatin 40 mg orally once daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac biomarkers (NT-Pro BNP, ST2 and MPO)
Time Frame: baseline and 3 months ( after completion of 4 cycles of AC chemotherapy)
change from baseline in Serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), suppression of tumorigenicity-2 (ST2), myeloperoxidase (MPO), and cholesterol using enzyme-linked immunosorbent assay (ELISA) kits and standard biochemical methods according to manufacturer instructions
baseline and 3 months ( after completion of 4 cycles of AC chemotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Chair: Gamal Omran, phD, Faculty of pharmacy
  • Study Chair: Noha El-Bassiouny, phD, Faculty of pharmacy
  • Study Director: Amira B Kassem, PhD, Faculty of pharmacy
  • Principal Investigator: Mohamed omar, Damanhour Oncology Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Actual)

October 20, 2024

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1121PP45

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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