This phase II trial studies how well simvastatin works in treating patients with stage I-II breast cancer. 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03454529.
PRIMARY OBJECTIVES:
I. Evaluate the relationship between short-term use of oral simvastatin on change in expression of Ki-67 as a candidate biomarker of breast tumor proliferation among women with clinical stage 0 in situ and 1 or 2- primary invasive breast cancer.
II. Evaluate the relationship between short-term use of oral simvastatin on changes in other candidate predictive markers of breast tumor proliferation (cyclin D1 and P27), changes in a marker of apoptosis (cleaved caspase-3 [CC3]), changes in a marker of inflammation (c-reactive protein [CRP]), novel additional biomarkers changes in the composition of the plasma membrane (lipid rafts), changes in activation of signaling markers (phosphorylation [p]Akt, pMAPK, pEGFR, PHER2) and changes in serum levels of 27-hydroxycholesterol (27OHC) and tumor expression of CYP27A1.
III. To conduct exploratory analyses comparing the effect of statins on breast tumor proliferation and apoptosis in groups defined by tumor expression of hydroxymethylglutaryl co-enzyme A (CoA) reductase (HMG-CoA), estrogen receptor (ER)/progesterone receptor (PR) status, HER2neu, and tumor grade.
OUTLINE:
Patients receive simvastatin orally (PO) daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity.
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorMichael Steven Simon
