Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT00807950
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00807950
Study Brief:
Protocol Section:
NCT00807950