Breast Cancer
Conditions
Keywords
Crestor, TFBP, rosuvastatin
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.
Interventions
DRUGrosuvastatin
Taken orally once a day for 4 weeks
Sponsors
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Institutes of Health (NIH)
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Tissue Factor Bearing Microparticles | 4 weeks | Comparison of plasma microparticle concentration between baseline and week 4 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rosuvastatin 20mg Rosuvastatin 20mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks | 9 |
| Rosuvastatin 40mg Rosuvastatin 40mg taken orally once a day for 4 weeks
rosuvastatin: Taken orally once a day for 4 weeks | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Rosuvastatin 20mg | Rosuvastatin 40mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 10 Participants | 19 Participants |
| Sex/Gender, Customized Female | 9 participants | 10 participants | 19 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 9 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Mean Change of Tissue Factor Bearing Microparticles
Comparison of plasma microparticle concentration between baseline and week 4
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 20mg | Mean Change of Tissue Factor Bearing Microparticles | 102 microparticles per microliter | Standard Deviation 586 |
| Rosuvastatin 40mg | Mean Change of Tissue Factor Bearing Microparticles | -618 microparticles per microliter | Standard Deviation 624 |