Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
|ClinicalTrials.gov Identifier: NCT00416403|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : December 13, 2012
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: fluvastatin sodium Procedure: Breast Cancer Surgery Only - Arm III||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer|
|Study Start Date :||July 2006|
|Primary Completion Date :||September 2007|
|Study Completion Date :||June 2011|
Experimental: Arm I
Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: fluvastatin sodium
Experimental: Arm II
Patients receive oral fluvastatin sodium as in arm I at a higher dose.
Drug: fluvastatin sodium
Experimental: Arm III
Patients do not receive fluvastatin sodium. breast Cancer surgery only
Procedure: Breast Cancer Surgery Only - Arm III
Breast Cancer Surgery
- Change in proliferation after statin exposure, as measured by Ki-67 level [ Time Frame: up to 6 weeks ]
- Blood and serum markers, including C-reactive protein, cleaved caspase 3, HER2, CD68, macrophages and immunoregulatory CD25 T cells, estrogen and progesterone receptors, mRNA, low-density lipoprotein, and cholesterol [ Time Frame: up to 6 weeks ]
- Presence of comedo necrosis [ Time Frame: up to 6 weeks ]
- Safety [ Time Frame: up to 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416403
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115-6084|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Study Chair:||Laura J. Esserman, MD, MBA||University of California, San Francisco|