Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
NCT ID: NCT00416403
Last Updated: 2012-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2006-07-31
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 sodium.
Secondary
* Determine whether statin use differentially affects specific types of DCIS/early-stage breast cancer (comedo, estrogen receptor \[ER\]-positive, ER-negative).
* Compare differences between tissue staining of CD68, circulating macrophages, and regulatory T cells in these patients.
* Assess the feasibility of using inherent susceptibility (mRNA polymerase chain reaction testing) to predict response to statins in these patients.
OUTLINE: This is a randomized, controlled, single-blind, multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms I or II). Patients accrued as control participants are assigned to arm III.
* Arm I: Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral fluvastatin sodium as in arm I at a higher dose.
* Arm III (control): Patients do not receive fluvastatin sodium. All patients then undergo definitive surgery.
Patients in arms I and II undergo blood collection at baseline and at the time of surgery for biomarker analysis. Patients in arm III undergo blood collection at baseline and then approximately 1 month later. Tissue is collected from patients in all arms at the time of surgery. Blood and tissue samples are examined for biological markers, including Ki-67, C-reactive protein, cleaved caspase 3, HER2, CD68 gene, and estrogen and progesterone receptors by immunohistochemistry. Markers of inflammation (e.g., comedo necrosis macrophages and CD25-positive T cells), low-density lipoprotein, and cholesterol are also analyzed. Serum mRNA is measured by polymerase chain reaction.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
fluvastatin sodium
Given orally
Arm II
Patients receive oral fluvastatin sodium as in arm I at a higher dose.
fluvastatin sodium
Given orally
Arm III
Patients do not receive fluvastatin sodium. breast Cancer surgery only
Breast Cancer Surgery Only - Arm III
Breast Cancer Surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fluvastatin sodium
Given orally
Breast Cancer Surgery Only - Arm III
Breast Cancer Surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura J. Esserman, MD, MBA
Role: STUDY_CHAIR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Garwood ER, Kumar AS, Baehner FL, Moore DH, Au A, Hylton N, Flowers CI, Garber J, Lesnikoski BA, Hwang ES, Olopade O, Port ER, Campbell M, Esserman LJ. Fluvastatin reduces proliferation and increases apoptosis in women with high grade breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):137-44. doi: 10.1007/s10549-009-0507-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCSF-047522
Identifier Type: -
Identifier Source: secondary_id
UCSF-H8409-26206-01
Identifier Type: -
Identifier Source: secondary_id
MSKCC-06041
Identifier Type: -
Identifier Source: secondary_id
CDR0000522934
Identifier Type: -
Identifier Source: org_study_id