Overview
Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
Status:
Completed
Completed
Trial end date:
2011-06-01
2011-06-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of California, San FranciscoCollaborator:
National Cancer Institute (NCI)Treatments:
Fluvastatin
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