Rosuvastatin in Treating Women With Cardiovascular Complications Who Are Undergoing Chemotherapy For Breast Cancer

Wake Forest University (WFU)

Status and phase: Terminated; Phase 1

Conditions: Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Cardiovascular Complications; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage I Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Treatments: Other: survey administration; Drug: rosuvastatin; Procedure: management of therapy complications; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01051401

NCI-2010-00125 (Registry Identifier)

IRB00009933

CCCWFU 98509 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 5 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups, including a placebo group

Arm I (rosuvastatin)

Experimental group

Description:

Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Treatment:

Procedure: management of therapy complications

Drug: rosuvastatin

Other: survey administration

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: placebo

Procedure: management of therapy complications

Other: survey administration