The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03454529|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Invasive Breast Carcinoma Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7||Other: Laboratory Biomarker Analysis Drug: Simvastatin||Phase 2|
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 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]) and as novel additional biomarkers changes in the composition of the plasma membrane (lipid rafts) and changes in activation of signaling markers (phosphorylation [p]Akt, pMAPK, pEGFR, PHER2).
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.
Patients receive simvastatin orally (PO) daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Statins on Markers of Breast Cancer Proliferation and Apoptosis in Women With Early Stage Breast Cancer|
|Actual Study Start Date :||March 9, 2018|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: Treatment (simvastatin)
Patients receive simvastatin PO daily for 2-4 weeks in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Change in Ki-67 expression assessed in tumor tissue by immunohistochemistry [ Time Frame: Baseline up to 4 weeks ]Will be described as average pre-post differences in percent positive cells with 95% Wilson confidence intervals and tested with a paired t-test.
- Changes in other candidate markers associated with breast tumor proliferation including cyclin D1 and P27 [ Time Frame: Baseline up to 4 weeks ]
- cleaved caspase-3 (CC3) as a marker of apoptosis [ Time Frame: Baseline up to 4 weeks ]
- c-reactive protein (CRP) as a marker of inflammation [ Time Frame: Baseline up to 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454529
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Michael S. Simon, M.D. 313-576-8727 firstname.lastname@example.org|
|Principal Investigator: Michael S. Simon, M.D., MPH|
|Sub-Investigator: David Gorski, M.D., PhD.|
|Sub-Investigator: Amy Weise, D.O.|
|Sub-Investigator: Keiva L. Bland, M.D.|
|Sub-Investigator: Lydia Choi, M.D.|
|Sub-Investigator: Lawrence Flaherty, M.D.|
|Principal Investigator:||Michael Simon||Barbara Ann Karmanos Cancer Institute|