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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm I (rosuvastatin)

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

Group Type EXPERIMENTAL

rosuvastatin

Intervention Type DRUG

Given PO

survey administration

Intervention Type OTHER

Correlative study

management of therapy complications

Intervention Type PROCEDURE

Arm II (placebo)

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given PO

survey administration

Intervention Type OTHER

Correlative study

management of therapy complications

Intervention Type PROCEDURE

Interventions

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rosuvastatin

Given PO

Intervention Type DRUG

placebo

Given PO

Intervention Type OTHER

survey administration

Correlative study

Intervention Type OTHER

management of therapy complications

Intervention Type PROCEDURE

Other Intervention Names

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PLCB complications of therapy, management of

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No