Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | October 2010 |
| End Date: | December 2020 |
A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
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.
(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.
- 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.
"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.
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
We found this trial at
2
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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