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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00416403
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ (DCIS) or stage I breast cancer by stereotactic core or incisional biopsy
* Planning to undergo surgery in 3-6 weeks
* Patients undergoing re-excision due to evidence of tumor present at surgical margins are eligible
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* ALT and AST ≤ 10% above upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to tolerate statins
* Willing to undergo 2 blood draws (separated by approximately 3-4 weeks) during study participation (control arm)
PRIOR CONCURRENT THERAPY:
* No other concurrent statins
* No concurrent chemotherapy
* No concurrent administration of any of the following:
* Niacin
* Propranolol
* Cholestyramine
* Cyclosporine
* Digoxin
* Erythromycin
* Itraconazole
* Gemfibrozil
* Phenytoin
* Diclofenac
* Tolbutamide
* Glyburide
* Losartan
* Cimetidine
* Ranitidine
* Omeprazole
* Rifampin
* Warfarin
* No initiation of new hormonal therapy during study participation
* Concurrent participation in other clinical trials (e.g., for DCIS or prevention) is allowed
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00416403
Study Brief:
Protocol Section:
NCT00416403