Phase II Study of Simvastatin in Primary Breast Cancer; Test of Its Potential Selectivity on Basal Subtype Breast Cancer

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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 hypothesize that tumor genomic changes would correlate with tumor response to Simvastatin. We are also looking to correlate Simvastatin biological effects with the expression pattern of initial status of primary tumor. In addition, we hypothesize that Simvastatin-induced tumor gene expression changes may correlate with tumor and plasma proteomics, peripheral blood mononuclear cell gene expression changes, and pharmacogenetics, and that these analyses may further refine the selection of patients most likely to benefit from Simvastatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.