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


Phase 1
N/A
N/A
Open (Enrolling)
Female
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

William Hundley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98509

NCT ID:

NCT01051401

Start Date:

January 2010

Completion Date:

Related Keywords:

  • 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
  • Breast Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157