A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Reduction of tissue factor bearing microparticles
Assess the reduction of tissue factor bearing microparticles in metastatic breast cancer treated with 4 weeks of rosuvastatin by Wilcoxon signed-rank test for each arm.
Jeffrey B. Zwicker, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|