Rosuvastatin in Treating Women With Cardiovascular Complications Who Are Undergoing Chemotherapy For Breast Cancer
Statin Therapy as a Protective Technique for Potential Cardiovascular Event Occurrences Among Breast Cancer Patients Undergoing Chemotherapy Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (rosuvastatin)
Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
|
Other Names:
Given PO
Correlative study
|
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
|
Other Names:
Given PO
Other Names:
Correlative study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc)
Time Frame: At baseline
|
At baseline
|
|
Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc)
Time Frame: 3 months
|
3 months
|
|
Rates of side-effects in the two groups
Time Frame: After 3 months
|
After 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: William Hundley, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00009933
- NCI-2010-00125 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CCCWFU 98509 (Other Identifier: Wake Forest University Health Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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