NCT07668076

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

September 17, 2023

Last Update Submit

June 22, 2026

Conditions

Breast CancerDoxorubicin Induced Cardiomyopathy

Keywords

Breast CancerDoxorubicin CardiotoxicityAtorvastatinNT-ProBNPST2MPO

Outcome Measures

Primary Outcomes (1)

  • cardiac biomarkers (NT-Pro BNP, ST2 and MPO)

    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)

Study Arms (2)

control arm

NO INTERVENTION

atorvastatin arm

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

atorvastatin 40 mg orally once daily for 3 months.

atorvastatin arm

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour university

Beheira, Damanhour, 22511, Egypt

Location

Related Publications (4)

  • Riad A, Bien S, Westermann D, Becher PM, Loya K, Landmesser U, Kroemer HK, Schultheiss HP, Tschope C. Pretreatment with statin attenuates the cardiotoxicity of Doxorubicin in mice. Cancer Res. 2009 Jan 15;69(2):695-9. doi: 10.1158/0008-5472.CAN-08-3076.

    PMID: 19147586BACKGROUND

  • Abdel-Qadir H, Bobrowski D, Zhou L, Austin PC, Calvillo-Arguelles O, Amir E, Lee DS, Thavendiranathan P. Statin Exposure and Risk of Heart Failure After Anthracycline- or Trastuzumab-Based Chemotherapy for Early Breast Cancer: A Propensity Score-Matched Cohort Study. J Am Heart Assoc. 2021 Jan 19;10(2):e018393. doi: 10.1161/JAHA.119.018393. Epub 2021 Jan 6.

    PMID: 33401953BACKGROUND

  • Seicean S, Seicean A, Plana JC, Budd GT, Marwick TH. Effect of statin therapy on the risk for incident heart failure in patients with breast cancer receiving anthracycline chemotherapy: an observational clinical cohort study. J Am Coll Cardiol. 2012 Dec 11;60(23):2384-90. doi: 10.1016/j.jacc.2012.07.067. Epub 2012 Nov 7.

    PMID: 23141499BACKGROUND

  • Henninger C, Fritz G. Statins in anthracycline-induced cardiotoxicity: Rac and Rho, and the heartbreakers. Cell Death Dis. 2017 Jan 19;8(1):e2564. doi: 10.1038/cddis.2016.418.

    PMID: 28102848BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Gamal Omran, phD

    Faculty of pharmacy

    STUDY CHAIR

  • Noha El-Bassiouny, phD

    Faculty of pharmacy

    STUDY CHAIR

  • Amira B Kassem, PhD

    Faculty of pharmacy

    STUDY DIRECTOR

  • Mohamed omar

    Damanhour Oncology Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2023

First Posted

June 25, 2026

Study Start

November 15, 2022

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

June 25, 2026

Record last verified: 2025-09

Locations

EG(1)