Phase 2 N=279 Randomized Quadruple-blind Prevention

Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)

Breast Cancer · Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01988571 ↗

Enrolled (actual)

279

Serious AEs

12.5%

Results posted

Jan 2022

Primary outcome: Primary: Left Ventricular Ejection Fraction (LVEF) — 58.1; 57.9 percent ejected from LV per heartbeat — p=0.84

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atorvastatin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Left Ventricular Ejection Fraction (LVEF)	58.1; 57.9	0.84
SECONDARY End Diastolic Volume	123; 125	—
SECONDARY End Systolic Volume	51.8; 52.9	—
SECONDARY Stroke Volume	71; 72.2	—
SECONDARY Left Ventricular (LV) Mass	88.4; 87.5	—
SECONDARY Pulse Wave Velocity	5.73; 5.51	—
SECONDARY Hopkins Verbal Learning Test (HVLT) Total Recall	28.5; 27.5	—
SECONDARY Controlled Oral Word Association (COWA)	41.6; 44.7	—
SECONDARY Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Applied Cognition - General Concerns - Short Form 4a	45.57; 46.55	—
SECONDARY Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Fatigue Short Form 41	48.17; 49.29	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01988571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.