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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00416403 |
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.
Condition | Intervention | Phase |
Breast Cancer |
Drug: fluvastatin sodium Procedure: observation |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
Drug Information available for: | Fluvastatin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control |
Official Title: | Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | July 2006 |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: fluvastatin sodium
Given orally
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Arm II: Experimental
Patients receive oral fluvastatin sodium as in arm I at a higher dose.
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Drug: fluvastatin sodium
Given orally
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Arm III: No Intervention
Patients do not receive fluvastatin sodium.
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Procedure: observation
Patients do not receive fluvastatin sodium.
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OBJECTIVES:
Primary
Secondary
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planning to undergo surgery in 3-6 weeks
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent administration of any of the following:
United States, California | |||||
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | ||||
San Francisco, California, United States, 94115 | |||||
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |||||
United States, Illinois | |||||
University of Chicago Cancer Research Center | Recruiting | ||||
Chicago, Illinois, United States, 60637-1470 | |||||
Contact: Olufunmilayo I. Falusi Olopade, MD, FACP 773-702-6149 | |||||
United States, Massachusetts | |||||
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center 617-582-8480 | |||||
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: Elisa Rush Port, MD 212-639-5461 porte@mskcc.org |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Laura J. Esserman, MD, MBA | UCSF Helen Diller Family Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000522934, UCSF-047522, UCSF-H8409-26206-01, MSKCC-06041 |
First Received: | December 27, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00416403 |
Health Authority: | Unspecified |
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