Viewing Study NCT00416403



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Study NCT ID: NCT00416403
Status: COMPLETED
Last Update Posted: 2012-12-13
First Post: 2006-12-27

Brief Title: Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
Sponsor: University of California San Francisco
Organization: University of California San Francisco

Study Overview

Official Title: Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ DCIS or Stage I Breast Cancer
Status: COMPLETED
Status Verified Date: 2012-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 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: 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 sodium

Secondary

Determine whether statin use differentially affects specific types of DCISearly-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 eg 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
UCSF-047522 None None None
UCSF-H8409-26206-01 None None None
MSKCC-06041 None None None