Clinical trial · Interventional
The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
The Effect of Statins on Markers of Breast Cancer Proliferation and Apoptosis in Women With Early Stage Breast Cancer
NCT03454529CI-TRIAL-00068429completedPhase 2Results postedClinicalTrials.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 purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and reduce the aggressiveness of breast cancer cells.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage II Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (simvastatin)
- description
- Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Simvastatin
Primary outcomes (1)
- measure
- Change in Ki-67 Expression Assessed in Tumor Tissue by Immunohistochemistry
- timeFrame
- Baseline up to 4 weeks
- description
- Differences in % positive cells pre and post treatment along with 95% confidence interval
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Histologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neu * Clinical stage I or II breast cancer for which there will be at least a 2 week period of time between diagnosis and definitive surgery * Performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1) * Not currently pregnant during the study; participants will be informed that the use of contraceptive pills is contraindicated because it may interfere with the study drug and it may be harmful to the woman who has been diagnosed with breast cancer Exclusion Criteria: * Plans for administration of neoadjuvant chemotherapy or hormonal therapy * Insufficient tissue on diagnostic core breast biopsy for analysis * Previous or concurrent malignancy (with the exception of non-melanomatous skin cancer) * Severe gastrointestinal disorder * Current use of statins or fibrates for any time during the 3 months prior to the study * Proven hypersensitivity to statins * White blood cell (WBC) \< 3,500/mm\^3 * Platelet (Plt) \< 120,000/mm\^3 * Hemoglobin (HgB) \< 10 g/dL * Aspartate aminotransferase (AST) \> 45 U/L * Alanine aminotransferase (ALT) \> 45 U/L * Creatinine \> 1.5 mg/dL * Bilirubin \> 1.15 mg/dL * Creatine kinase measurement (CPK) \> or = 250 mg/dL * Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply to the protocol procedures * Active infections * Cardiac failure, class I-IV * Current anticoagulant or antiplatelet aggregation therapy * Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial infarction * Current lactation
References
Publications (1)
- DERIVEDAsari K, Sun WT, Kok ZH, Lam YH, Ng BL, Saunders V, White DL, Chuah C, Xiang W. Simvastatin enhances the efficacy of nilotinib in chronic myeloid leukaemia by post-translational modification and drug transporter modulation. Anticancer Drugs. 2021 Jun 1;32(5):526-536. doi: 10.1097/CAD.0000000000001028. PMID 33587350