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

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 randomised phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.

Official Title

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

Conditions

• Breast Cancer

Study Type

Interventional

Study Design

 

Treatment, Randomised, Single Blind, Active Control Study.

Further Details

Primary Outcome Measures:

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

Secondary Outcome Measures:

• Blood and serum markers, including C-reactive protein, cleaved caspase 3, HER2, CD68, macrophages and immunoregulatory CD25 T cells, oestrogen and progesterone receptors, mRNA, low-density lipoprotein, and cholesterol
• Presence of comedo necrosis
• Safety

Study Start

July 2006

Eligibility & Criteria

• Genders Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 tumour 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

Total Enrolment

60

Contact Details

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416403

Locations

UCSF Helen Diller Family Comprehensive Cancer Center 
San Francisco, California
United States, 94115  
Contact: Clinical Trials Office: 877-827-3222          
 
University of Chicago Cancer Research Center
Chicago, Illinois
United States, 60637-1470  
Contact: Olufunmilayo I Falusi Olopade, MD FACP: 773-702-6149          
 
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts
United States, 02115  
Contact: Clinical Trials Office – Dana-Farber/Harvard Cancer Center: 617-582-8480          
 
Memorial Sloan-Kettering Cancer Center
New York, New York
United States, 10021  
Contact: Elisa Rush Port, MD: 212-639-5461 porte@mskcc.org

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center
 
National Cancer Institute (NCI)

Investigators

Study Chair:

Laura J. Esserman, MD, MBA     
UCSF Helen Diller Family Comprehensive Cancer Center