Breast CancerPhase 2NCT07668076
The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients
A Phase 2 study testing Atorvastatin in people with Breast Cancer and Doxorubicin Induced Cardiomyopathy, run by Damanhour University at 1 site in Egypt.
Trial summary
the study aims to evaluate the cardioprotective effect of atorvastatin in breast cancer female patients treated with doxorubicin based chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Doxorubicin Induced Cardiomyopathy
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 20 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with newly diagnosed breast cancer and ≥ 18 years old.
- Naive to chemotherapy.
- Left ventricular ejection fraction (LVEF) > 55%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer, Doxorubicin Induced Cardiomyopathy
- Being tested
- Atorvastatin
- Keywords
- Breast Cancer, Doxorubicin Cardiotoxicity, Atorvastatin, NT-ProBNP, ST2, MPO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
atorvastatin 40 mg orally once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| control arm | No intervention | Not described |
| atorvastatin arm | Experimental | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 3 months ( after completion of 4 cycles of AC chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start15 Nov 2022
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha El Bassiouny, Damanhour University
- Investigators
- Gamal Omran, phD, Study chair, Faculty of pharmacyNoha El-Bassiouny, phD, Study chair, Faculty of pharmacyAmira B Kassem, PhD, Study director, Faculty of pharmacyMohamed omar, Principal investigator, Damanhour Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668076
- Sponsor's protocol ID
- 1121PP45
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19147586Abdel-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.
PubMed 33401953Seicean 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.
PubMed 23141499Henninger 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.
PubMed 28102848
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients Treated With Doxorubicin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT07668076
- Acronym / sponsor ID
- 1121PP45
- Conditions
- Breast Cancer, Doxorubicin Induced Cardiomyopathy
- Keywords
- Breast Cancer, Doxorubicin Cardiotoxicity, Atorvastatin, NT-ProBNP, ST2, MPO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study aims to evaluate the cardioprotective effect of atorvastatin in breast cancer female patients treated with doxorubicin based chemotherapy
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | – |
| atorvastatin arm | Experimental | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with newly diagnosed breast cancer and ≥ 18 years old.
- Naive to chemotherapy.
- Left ventricular ejection fraction (LVEF) > 55%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatinatorvastatin 40 mg orally once daily for 3 months. | Drug | atorvastatin arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 19147586Riad 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.
- Background: PubMed 33401953Abdel-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.
- Background: PubMed 23141499Seicean 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.
- Background: PubMed 28102848Henninger 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal Omran, phD study chair
Faculty of pharmacy
Noha El-Bassiouny, phD study chair
Faculty of pharmacy
Amira B Kassem, PhD study director
Faculty of pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Breast Cancer and Doxorubicin Induced Cardiomyopathy, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac biomarkers (NT-Pro BNP, ST2 and MPO) (time frame: baseline and 3 months ( after completion of 4 cycles of AC chemotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668076, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.