Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Procedure: Breast Cancer Surgery Only - Arm III
- Registration Number
- NCT00416403
- Lead Sponsor
- University of California, San Francisco
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II fluvastatin sodium Patients receive oral fluvastatin sodium as in arm I at a higher dose. Arm III Breast Cancer Surgery Only - Arm III Patients do not receive fluvastatin sodium. breast Cancer surgery only Arm I fluvastatin sodium Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Change in proliferation after statin exposure, as measured by Ki-67 level up to 6 weeks
- Secondary Outcome Measures
Name Time Method 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 up to 6 weeks Presence of comedo necrosis up to 6 weeks Safety up to 6 weeks
Trial Locations
- Locations (4)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, 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
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States