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

Phase 1

Terminated

• Conditions: Cardiovascular Complications; Stage I Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage II Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
• Interventions: Drug: rosuvastatin; Other: placebo; Other: survey administration; Procedure: management of therapy complications

• Registration Number: NCT01051401
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (placebo)	survey administration	Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
Arm I (rosuvastatin)	management of therapy complications	Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
Arm I (rosuvastatin)	survey administration	Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
Arm I (rosuvastatin)	rosuvastatin	Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
Arm II (placebo)	placebo	Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
Arm II (placebo)	management of therapy complications	Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
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)	3 months

Secondary Outcome Measures

Name	Time	Method
Rates of side-effects in the two groups	After 3 months
Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc)	3 months

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States