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Protocol No. WF98213

Principal Investigator Campbell, Toby

Phase II/III

Age Group Adult

Scope National

Sponsor Type National

Title Preventing Anthracycline Cardiovascular Toxicity with Statins (Prevent)

Objective The purpose of this research study is to see if Atorvastatin decreases the chance of developing heart problems in patients receiving anthracycline based chemotherapy for breast cancer or lymphoma. Atorvastatin has been approved by the US Food and Drug Administration (FDA), but it has not been approved to lessen the chance of heart problems related to chemotherapy. In this study Atorvastatin will be compared to placebo. A placebo is a substance, like a sugar pill, that is not thought to have any effect on your disease or condition. In this study patients will either receive the active study medication (Atorvastatin) or placebo, which is not active.
This study will also include questions related to patients thinking process and quality of life

Treatment Atorvastatin or placebo by mouth daily

Description Phase 2/3 study to see if using Atrovastatin can prevent Anthracycline Cardiovascular Toxicity

Key Eligibility
  • Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma Stage I-IV. (Patients should have a > 2 year life expectancy)
  • Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
  • greater than 21 years of age
  • Patients that are receiving or have received chemotherapy regimens are allowed.
  • Prior administration of anthracyclines is acceptable if therapy was completed > 6 months prior to study enrollment.
  • Able to hold breath for 10 seconds
  • ECOG 0 or 1
  • Breast patients with tissue expanders are not allowed with the exception of tissue expanders made of material that are MRI compatible
  • Patients with breast implants are usually permitted to have an MRI
  • Adequate lipid panel, liver and thyroid function and glucose levels
  • Can not be pregnant or breast feeding
  • No current use of Rifampin and Digoxi
  • No symptomatic Claustrophobia
  • If between the ages of 40 to 75 years with diabetes, they are excluded
  • No significant ventricular arrhythmias
  • No current use of statin therapy
  • No atherosclerotic cardiovascular disease
  • Must be able to have a MRI done

  • Applicable Disease Sites Breast; Lymphoma

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park