Clinical trial · Interventional
The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients
The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients Treated With Doxorubicin-based Chemotherapy
NCT07668076CI-TRIAL-00115835completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
the study aims to evaluate the cardioprotective effect of atorvastatin in breast cancer female patients treated with doxorubicin based chemotherapy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Doxorubicin Induced Cardiomyopathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control arm
- type
- EXPERIMENTAL
- label
- atorvastatin arm
- interventionNames
- Drug: Atorvastatin
Primary outcomes (1)
- measure
- cardiac biomarkers (NT-Pro BNP, ST2 and MPO)
- timeFrame
- baseline and 3 months ( after completion of 4 cycles of AC chemotherapy)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDRiad 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 19147586
- BACKGROUNDAbdel-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 33401953
- BACKGROUNDSeicean 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 23141499
- BACKGROUNDHenninger 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 28102848