This randomized pilot clinical trial studies rosuvastatin in treating women with cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for breast cancer
OBJECTIVES: I. Evaluate the feasibility of administering Rosuvastatin to breast cancer patients undergoing treatment with anthracyclines, paclitaxel, cyclophosphamide, and trastuzumab for breast cancer. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive rosuvastatin orally (PO) once daily for 3 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5
Given PO
Given PO
Correlative study
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Whether the rate of statin adherence for patients taking chemotherapy is comparable to the rate of adherence found in prior studies (i.e., JUPITER study)
Time frame: 3 months
Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc)
Time frame: At baseline
Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc)
Time frame: 3 months
Rates of side-effects in the two groups
Time frame: After 3 months
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