Status:
UNKNOWN
Phase II Study of Simvastatin in Primary Breast Cancer; Test of Its Potential Selectivity on Basal Subtype Breast Cancer
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
We hypothesize that Simvastatin administration would result in selective killing of the basal subtype of breast cancer, in particular, CD44+/CD24- breast cancer cells in primary tumor. We further hypo...
Detailed Description
Primary Objectives 1\. Evaluate the biological response (proliferation and apoptosis) of Simvastatin in primary breast cancer. 2\. Evaluate the cell type specificity of Simvastatin effect on basal s...
Eligibility Criteria
Inclusion
- Female, age \>= 18 years. Page 14 of 28
- Histologic or cytologic diagnosis of breast carcinoma.
- Clinical T1-3 breast cancer with measurable primary breast tumor which is amenable to free-hand core biopsy
- Patients scheduled for definitive surgery
- Patients must not have received prior or scheduled to receive chemotherapy, hormonal therapy, radiotherapy, targeted therapy, or immunotherapy for the treatment of breast cancer.
- Karnofsky performance status of 70 or higher.
- Normal creatinine kinase
- Adequate organ function including the following:
- Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L Platelets \>= 100 x 109/L
- Hepatic:
- Bilirubin within normal range
- ALT or AST \<1.5 x upper limit normal
- Renal:
- creatinine \<= 1.5 x upper limit normal
- Signed informed consent from patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative pregnancy test within 7 days prior to study enrollment.
Exclusion
- Current treatment with HMG-CoA reductase inhibitors or other lipid lowering drugs
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Known hypersensitivity to Simvastatin
- Active liver disease or unexplained persistent elevations of serum transminases
- Pregnancy.
- Breast feeding
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00807950
Start Date
March 1 2008
End Date
December 1 2014
Last Update
January 22 2014
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074