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

NCT00416403 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000522934UCSF-047522UCSF-H8409-26206-01MSKCC-06041
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

breast cancer in situ; ductal breast carcinoma in situ; stage IA breast cancer; stage IB breast cancer

Outcome Measures

Primary Outcomes (1)

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

  up to 6 weeks

Secondary Outcomes (3)

• 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

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: fluvastatin sodium

Arm II

EXPERIMENTAL

Patients receive oral fluvastatin sodium as in arm I at a higher dose.

Drug: fluvastatin sodium

Arm III

EXPERIMENTAL

Patients do not receive fluvastatin sodium. breast Cancer surgery only

Procedure: Breast Cancer Surgery Only - Arm III

Interventions

fluvastatin sodium DRUG

Given orally

Arm I; Arm II

Breast Cancer Surgery Only - Arm III PROCEDURE

Breast Cancer Surgery

Arm III

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115-6084, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Garwood ER, Kumar AS, Baehner FL, Moore DH, Au A, Hylton N, Flowers CI, Garber J, Lesnikoski BA, Hwang ES, Olopade O, Port ER, Campbell M, Esserman LJ. Fluvastatin reduces proliferation and increases apoptosis in women with high grade breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):137-44. doi: 10.1007/s10549-009-0507-x.

  PMID: 19728082 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Laura J. Esserman, MD, MBA

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: July 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: June 1, 2011
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (4)