Status:
COMPLETED
The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
Lead Sponsor:
Michael Simon
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Invasive Breast Carcinoma
Stage I Breast Cancer AJCC v7
Eligibility:
FEMALE
19+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 cl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03454529
Start Date
March 9 2018
End Date
October 6 2021
Last Update
August 1 2023
Active Locations (1)
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1
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201