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.
Interventional
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.
4 weeks
No
Jeffrey B. Zwicker, MD
Principal Investigator
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
10-287
NCT01299038
October 2010
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |