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Phase 2 Completed N=24 Treatment

The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer

Breast Cancer · Stage I Breast Cancer AJCC v7 · Stage IA Breast Cancer AJCC v7 · Stage IB Breast Cancer AJCC v7
Source: ClinicalTrials.gov NCT03454529 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Change in Ki-67 Expression Assessed in Tumor Tissue by Immunohistochemistry — 1.3 percentage of cells expressing Ki67

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Ki-67 Expression Assessed in Tumor Tissue by Immunohistochemistry		 1.3 —

Eligibility Criteria

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) 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03454529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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