NCT01299038

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

A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	rosuvastatin	Taken orally once a day for 4 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2011-02-18
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study