Status:
COMPLETED
Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief 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: Thi...
Detailed Description
OBJECTIVES: Primary * Determine differences between measures of cell proliferation (Ki-67) in women with ductal carcinoma in situ (DCIS) or stage I breast cancer receiving neoadjuvant fluvastatin so...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00416403
Start Date
July 1 2006
End Date
June 1 2011
Last Update
December 13 2012
Active Locations (4)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
3
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065