Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer

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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed ductal carcinoma in situ (DCIS) or stage I breast cancer by stereotactic core or incisional biopsy
  -  Planning to undergo surgery in 3-6 weeks
  -  Patients undergoing re-excision due to evidence of tumor present at surgical margins are eligible
  -  Hormone receptor status not specified
  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

Relevance to patient case: not relevant