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

July 30, 2018 updated by: Wake Forest University Health Sciences

Statin Therapy as a Protective Technique for Potential Cardiovascular Event Occurrences Among Breast Cancer Patients Undergoing Chemotherapy Treatment

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

Study Overview

Status

Terminated

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

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: management of therapy complications
Other Names:
  • complications of therapy, management of
Drug: rosuvastatin
Given PO
Other: survey administration
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.
Procedure: management of therapy complications
Other Names:
  • complications of therapy, management of
Other: placebo
Given PO
Other Names:
  • PLCB
Other: survey administration
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

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: William Hundley, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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