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Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer

Phase 2
Not Enrolling
Breast Cancer

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Trial Information

Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer



- 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.

Inclusion Criteria


- 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


- 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)


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in proliferation after statin exposure, as measured by Ki-67 level

Outcome Time Frame:

up to 6 weeks

Safety Issue:


Principal Investigator

Laura J. Esserman, MD, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • breast cancer in situ
  • ductal breast carcinoma in situ
  • stage IA breast cancer
  • stage IB breast cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115