Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

NCT ID: NCT01299038

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-12-31

Brief Summary

Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. Studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. The purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.

Detailed Description

• Since no one knows which of the study options are best, participants will be "randomized" into the following study groups: Group 1 (regular dose of rosuvastatin) or Group 2 (higher dose of rosuvastatin).
• Participants will take 1 pill of rosuvastatin every day for 4 weeks. Each 4 week period is called a cycle.
• Participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. Laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group 1

Rosuvastatin 20mg taken orally once a day for 4 weeks

Group Type: ACTIVE_COMPARATOR

rosuvastatin

Intervention Type: DRUG

Taken orally once a day for 4 weeks

Group 2

Rosuvastatin 40mg taken orally once a day for 4 weeks

Group Type: ACTIVE_COMPARATOR

rosuvastatin

Intervention Type: DRUG

Taken orally once a day for 4 weeks

Interventions

rosuvastatin

Taken orally once a day for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Crestor

Eligibility Criteria

Inclusion Criteria

• Metastatic adenocarcinoma of the breast (Stage IV)
• Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)
• Minimum age 18 years
• ECOG Performance status of 0, 1 or 2
• Normal organ and marrow function as defined in the protocol

Exclusion Criteria

• Participants may not be receiving any other study agents
• Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks
• Any statin therapy within the last 3 weeks
• Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)
• Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
• Conditions predisposing to renal failure secondary to rhabdomyolysis
• Recent history of heavy alcohol use as judged by the treating physician
• Known to be pregnant (testing not required) or nursing
• History of rhabdomyolysis on statin therapy
• Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Zwicker, MD

Assistant Professor, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey I. Zwicker, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10-287

Identifier Type: -

Identifier Source: org_study_id