Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)

NCT01988571 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: IRB00038639U10CA0818511R01HL118740-01REBACCCWFU 98213NCI-2013-01760
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 51

Brief 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.

Conditions

Breast Cancer; Lymphoma

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

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction (LVEF)

  24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular ejection fraction by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.

  24 months

Secondary Outcomes (9)

• End Diastolic Volume

  24 months

• End Systolic Volume

  24 months

• Stroke Volume

  24 months

• Left Ventricular (LV) Mass

  24 months

• Pulse Wave Velocity

  24 months

Study Arms (2)

Arm 1 - Atorvastatin

ACTIVE COMPARATOR

One 40 mg Atorvastatin tablet each morning by mouth for 24 months

Drug: Atorvastatin

Arm 2 - Placebo

PLACEBO COMPARATOR

One placebo tablet each morning by mouth for 24 months.

Drug: Atorvastatin; Drug: Placebo

Interventions

Atorvastatin DRUG

40 mg tablet taken by mouth each morning for 24 months.

Also known as: Lipitor

Arm 1 - Atorvastatin; Arm 2 - Placebo

Placebo DRUG

One placebo tablet taken each morning orally for 24 months.

Also known as: sugar pill

Arm 2 - Placebo

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (51)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48085, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Hope Women's Cancer Centers-Asheville

Asheville, North Carolina, 28816, United States

Location

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

Location

Novant Health Cancer Institute - Huntersville

Huntersville, North Carolina, 28078, United States

Location

Southern Oncology Specialists-Huntersville

Huntersville, North Carolina, 28078, United States

Location

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina, 27284, United States

Location

Novant Health Cancer Specialists-Matthews

Matthews, North Carolina, 28105, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, 43214, United States

Location

Doctors Hospital

Columbus, Ohio, 43228, United States

Location

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, 43015, United States

Location

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Centra Lynchburg Hematology-Oncology Clinic Inc

Lynchburg, Virginia, 24501, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Shenandoah Oncology PC

Winchester, Virginia, 22601, United States

Location

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

Location

Related Publications (3)

• Grizzard PJ, O'Connell NS, Rapp SR, Olson KC, Bellissimo MP, Hughes AN, Ladd AC, Weaver KE, Wagner LI, Ruddy KJ, Ky B, D'Agostino RB, Hundley WG. Preserved Cognitive Function After Statin Administration During Cancer Treatment With Doxorubicin: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538325. doi: 10.1001/jamanetworkopen.2025.38325.

  PMID: 41118164 DERIVED

• Sutton AL, O'Connell NS, Lucas AR, Olson KC, Reding KW, Sheppard VB, Ky B, Ruddy KJ, Weaver KE, Hundley WG. Socioeconomic status and left ventricular ejection fraction decline in breast cancer survivors following receipt of doxorubicin (PREVENT WF-98213). Cardiooncology. 2025 Feb 5;11(1):11. doi: 10.1186/s40959-025-00311-y.

  PMID: 39910652 DERIVED

• Hundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM Evid. 2022 Sep;1(9):10.1056/evidoa2200097. doi: 10.1056/evidoa2200097. Epub 2022 Aug 18.

  PMID: 36908314 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma

Interventions

Atorvastatin; Sugars

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Carbohydrates

Results Point of Contact

• Title: Lead Biostatistician
• Organization: Wake Forest NCI Community Oncology Research Program Research Base

NCORP@wakehealth.edu

336-716-0891

Study Officials

• Gregory Hundley, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 20, 2013
• Study Start: February 1, 2014
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: January 4, 2022
• Results First Posted: January 4, 2022

Record last verified: 2021-12

Locations

US (51)