Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)

• Status: Completed
• Trial end date: 2020-09-24
• Target enrollment: 0
• Participant gender: Female

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 women receiving adjuvant anthracycline-based chemotherapy for breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Newly diagnosed Stage I-III female breast cancer (including inflammatory breast cancer)

• Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin)

• 30 to 80 years of age

• LVEF > 50% (Most recent within the last 5 years)

• Prior chemotherapy regimen not containing anthracyclines is allowed

• Able to hold breath for 15 seconds

• Prior cancers allowed if no evidence of disease in last 5 years

• 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 PVCs/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response; coronary artery disease; acute myocardial infarction within 28 days

• Current use of CYP 3A4 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