Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
Condition: Breast Cancer; Lymphoma
MeSH terms: Lymphoma; Breast Neoplasms
Intervention: Atorvastatin; Placebo
Intervention description: 40 mg tablet taken by mouth each morning for 24 months.; One placebo tablet taken each morning orally for 24 months.
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 279.0
Sex: All
Minimum age: 21 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Stage I breast cancer; Stage II breast cancer; Stage III breast cancer; Stage I Lymphoma; Stage II Lymphoma; Stage III Lymphoma; Stage IV Lymphoma

Summary:

      The purpose of this research study is to see if Atorvastatin (Lipitor) 40 mg by mouth daily
      decreases the chance of developing heart problems in individuals receiving adjuvant
      anthracycline-based chemotherapy for breast cancer of lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 adjuvant chemotherapy with an Anthracycline (doxorubicin and
             epirubicin)

          -  21 years of age or older

          -  LVEF > 50% (Most recent within the last 5 years)

          -  Prior administration of anthracyclines is acceptable if therapy was completed > 6
             months prior to study enrollment

          -  Patients that are receiving or have received chemotherapy regimens are allowed

          -  Able to hold breath for 10 seconds

          -  Prior cancers allowed if no evidence of disease in last 5 years

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

        Exclusion Criteria:

          -  Prior use of lipid-lowering therapy within the last 6 months

          -  Current postmenopausal hormone-replacement therapy

          -  Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood
             pressure >100 mm Hg)

          -  Scheduled to receive neoadjuvant chemotherapy with an anthracycline

          -  No active liver disease allowed

          -  Uncontrolled hypothyroidism

          -  Recent history (within past 3 years) of alcohol or drug abuse, inflammatory conditions
             such as lupus or inflammatory bowel disease, use of immunosuppressant agents, or
             another medical condition that might compromise safety or the successful completion of
             the study.

          -  Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial
             metal;pacemakers, defibrillators, functioning neurostimulator devices or other
             implanted electronic devices.

          -  Unstable angina; significant ventricular arrhythmias (>20 premature ventricular
             complexes (PVCs)/min due to gating difficulty) atrial fibrillation with uncontrolled
             ventricular response; coronary artery disease; acute myocardial infarction within 28
             days

          -  Current use of Cytochrome P450 (CYP3A4) inhibitors. These include Clarithromycin, HIV
             protease inhibitors, Itraconazole, grapefruit juice, Cyclosporine, Rifampin or Digoxin

          -  Current or history of hepatic dysfunction

          -  Unable to provide informed consent

          -  Claustrophobia

          -  Planning to move within 24 months of trial enrollment

          -  Pregnant or breast-feeding