Rosuvastatin in Treating Women With Cardiovascular Complications Who Are 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.

Inclusion Criteria:

Women receiving therapy for breast cancer without a history of cardiovascular disease An
low-density lipoprotein (LDL) cholesterol level of less than 160 mg per deciliter (3.4 MMol
per liter) Willingness to participate for the duration of the trial (3 months) Written
informed consent Triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter)

Exclusion Criteria:

Previous or current use of lipid-lowering therapy Current use of postmenopausal
hormone-replacement therapy Evidence of hepatic dysfunction (an alanine aminotransferase
level that was more than twice the upper limit of the normal range) Creatine kinase level
that was more than three times the upper limit of the normal range Creatinine level that
was higher than 2.0 mg per deciliter (176.8 umol per liter) Diabetes Uncontrolled
hypertension (systolic blood pressure > 190 mm Hg or diastolic blood pressure > 100 mm Hg)
Uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5
times the upper limit of the normal range) Recent history of alcohol or drug abuse or
another medical condition that might compromise safety or the successful completion of the
study Exclude patients with inflammatory conditions such as severe arthritis, lupus, or
inflammatory bowel disease, and patients taking immunosuppressant agents such as
cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids Pregnant women
are excluded from participation in this study