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Phase 3Recruiting

S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

Sponsored by SWOG Cancer Research Network

About this study

This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.

PRIMARY OBJECTIVES: I. To estimate the 2-year cumulative incidence of cardiac dysfunction and/or predefined cardiac events in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy and beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor. II. To develop a model including clinical factors and potential biomarkers to predict risk of cardiac dysfunction and/or predefined cardiac events in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy and beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces …

Where this study is enrolling (144)

  • City of Hope Comprehensive Cancer Center

    Duarte, California

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  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California

    Call 323-865-0451

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  • Contra Costa Regional Medical Center

    Martinez, California

    Call 925-957-5400

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  • City of Hope Mission Hills

    Mission Hills, California

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  • City of Hope Newport Beach

    Newport Beach, California

    Call 877-467-3411

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Show all 144 locations

  • City of Hope South Pasadena

    South Pasadena, California

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  • City of Hope South Bay

    Torrance, California

    Call 877-467-3411

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  • City of Hope Upland

    Upland, California

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  • Beebe Health Campus

    Rehoboth Beach, Delaware

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  • Bayhealth Hospital Kent Campus

    Dover, Delaware

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  • Beebe South Coastal Health Campus

    Frankford, Delaware

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  • Moffitt Cancer Center

    Tampa, Florida

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  • Cleveland Clinic-Weston

    Weston, Florida

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  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia

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  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia

    I'm interested

  • Northside Hospital

    Atlanta, Georgia

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  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia

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  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia

    I'm interested

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho

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  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho

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  • Decatur Memorial Hospital

    Decatur, Illinois

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  • Loyola University Medical Center

    Maywood, Illinois

    Call 708-226-4357

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  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois

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  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois

    Call (312) 864-0200

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  • Franciscan Saint Elizabeth Health - Lafayette East

    Lafayette, Indiana

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  • Franciscan Health Indianapolis

    Indianapolis, Indiana

    Call 317-528-7060

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  • Franciscan Health Mooresville

    Mooresville, Indiana

    Call 317-834-3603

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  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa

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  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa

    Call 515-241-3305

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  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa

    Call 515-241-3305

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  • Mercy Medical Center - Des Moines

    Des Moines, Iowa

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  • Mercy Cancer Center-West Lakes

    Clive, Iowa

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  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas

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  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas

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  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas

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  • HaysMed University of Kansas Health System

    Hays, Kansas

    Call 785-623-5774

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  • University of Kansas Cancer Center-West

    Kansas City, Kansas

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  • University of Kansas Cancer Center

    Kansas City, Kansas

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  • Olathe Health Cancer Center

    Olathe, Kansas

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  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas

    Call 785-295-8000

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  • Saint Joseph Hospital East

    Lexington, Kentucky

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  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana

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  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana

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  • Woman's Hospital

    Baton Rouge, Louisiana

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  • Our Lady of the Lake Medical Oncology

    Baton Rouge, Louisiana

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  • Louisiana Hematology Oncology Associates

    Baton Rouge, Louisiana

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  • Our Lady of the Lake Physicians Group - Medical Oncology

    Baton Rouge, Louisiana

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  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana

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  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland

    Call 443-643-3010

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  • Winchester Hospital

    Winchester, Massachusetts

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  • Lahey Hospital and Medical Center

    Burlington, Massachusetts

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  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan

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  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan

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  • Ascension Providence Hospitals - Southfield

    Southfield, Michigan

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  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan

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  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan

    Call 800-865-1125

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  • McLaren Cancer Institute-Bay City

    Bay City, Michigan

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  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan

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  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan

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  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan

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  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan

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  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan

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  • Henry Ford Hospital

    Detroit, Michigan

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  • McLaren Cancer Institute-Flint

    Flint, Michigan

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  • Singh and Arora Hematology Oncology PC

    Flint, Michigan

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  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan

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  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan

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  • Henry Ford Medical Center-Columbus

    Novi, Michigan

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  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan

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  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan

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  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota

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  • Hennepin County Medical Center

    Minneapolis, Minnesota

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  • Regions Hospital

    Saint Paul, Minnesota

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  • United Hospital

    Saint Paul, Minnesota

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  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota

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  • Monticello Cancer Center

    Monticello, Minnesota

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  • Mercy Hospital

    Coon Rapids, Minnesota

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  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota

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  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota

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  • University of Mississippi Medical Center

    Jackson, Mississippi

    Call 601-815-6700

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  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi

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  • Mercy Hospital Springfield

    Springfield, Missouri

    Call 417-269-4520

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  • Truman Medical Centers

    Kansas City, Missouri

    Call 816-404-4375

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  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri

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  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri

    Call 314-251-7058

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  • Saint Francis Medical Center

    Cape Girardeau, Missouri

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  • Capital Region Southwest Campus

    Jefferson City, Missouri

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  • University of Kansas Cancer Center - North

    Kansas City, Missouri

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  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri

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  • CoxHealth South Hospital

    Springfield, Missouri

    Call 417-269-4520

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  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri

    Call 314-353-1870

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  • Mercy Hospital South

    St Louis, Missouri

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  • Missouri Baptist Medical Center

    St Louis, Missouri

    Call 314-996-5569

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  • Mercy Hospital Saint Louis

    St Louis, Missouri

    Call 314-251-7066

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  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana

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  • Overlook Hospital

    Summit, New Jersey

    Call 908-522-2043

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  • Morristown Medical Center

    Morristown, New Jersey

    Call 973-971-5900

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  • Holy Name Hospital

    Teaneck, New Jersey

    Call 201-833-6312

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  • University of New Mexico Cancer Center

    Albuquerque, New Mexico

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  • Nyack Hospital

    Nyack, New York

    Call 845-348-8507

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  • Dickstein Cancer Treatment Center

    White Plains, New York

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  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio

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  • Aultman Health Foundation

    Canton, Ohio

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  • Geauga Hospital

    Chardon, Ohio

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  • The Christ Hospital

    Cincinnati, Ohio

    Call 513-585-0844

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  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio

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  • Case Western Reserve University

    Cleveland, Ohio

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  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio

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  • Cleveland Clinic Foundation

    Cleveland, Ohio

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  • North Coast Cancer Care

    Sandusky, Ohio

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  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio

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  • University Hospitals Sharon Health Center

    Wadsworth, Ohio

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  • South Pointe Hospital

    Warrensville Heights, Ohio

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  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio

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  • UH Seidman Cancer Center at Saint John Medical Center

    Westlake, Ohio

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  • UHHS-Westlake Medical Center

    Westlake, Ohio

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  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio

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  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio

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  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio

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  • Cleveland Clinic Akron General

    Akron, Ohio

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  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio

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  • Kaiser Permanente Northwest

    Portland, Oregon

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  • Oregon Health and Science University

    Portland, Oregon

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  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania

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  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania

    Call 800-836-0388

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  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania

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  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania

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  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina

    Call 864-241-6251

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  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina

    Call 864-241-6251

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  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina

    Call 864-241-6251

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  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee

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  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas

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  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas

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  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas

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  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia

    Call 540-332-5960

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  • Swedish Medical Center-First Hill

    Seattle, Washington

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  • University of Washington Medical Center - Montlake

    Seattle, Washington

    Call 800-804-8824

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  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington

    Call 360-788-8223

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  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington

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  • FHCC South Lake Union

    Seattle, Washington

    Call 800-804-8824

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  • West Virginia University Healthcare

    Morgantown, West Virginia

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  • Camden Clark Medical Center

    Parkersburg, West Virginia

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  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia

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  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia

    Call 304-243-6442

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Who can participate

Inclusion criteria

  • ✓STEP 1 REGISTRATION
  • ✓Patients must:
  • ✓1. Have metastatic breast cancer, AND
  • ✓2. Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND
  • ✓3. Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration.
  • ✓Examples of eligible HER-2 targeted therapy:
  • ✓Trastuzumab or a trastuzumab biosimilar
  • ✓Trastuzumab + chemotherapy or hormonal therapy
  • ✓Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)
  • ✓Ado-trastuzumab (Kadcyla®)
  • ✓Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.
  • ✓Patients must be at increased risk for cardiotoxicity defined by at least one of the following:
  • ✓1. Previous anthracycline exposure OR
  • ✓2. 1 or more of the following risk factors for heart disease:
  • ✓LVEF 50-54% by local ECHO read\*
  • ✓Age ≥ 65
  • ✓BMI ≥ 30 kg/m2
  • ✓Current or prior anti-hypertensive therapy
  • ✓Diagnosis of coronary artery disease (CAD)
  • ✓Diagnosis of diabetes mellitus
  • ✓Diagnosis of atrial fibrillation/flutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.
  • ✓Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in order to be randomized (Arms 1 and 2).
  • ✓Patients enrolling in the observational cohort (Arm 3) must be currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration.
  • ✓Patients must have a Zubrod Performance status of 0-2
  • ✓Patients must have a complete physical examination and medical history within 28 days prior to registration
  • ✓Patients must have LVEF \>= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab.
  • ✓If a 3D echocardiogram is performed at baseline, sites must ensure that standard 2D images, including 40chamber and 2-chamber views, are also obtained and submitted at subsequent timepoints.
  • ✓All follow-up echocardiograms (every 12 weeks) must be performed using 2D imaging to allow for standardized assessments. Follow-up scans must be completed at a site that can provide 2D images per protocol requirements. The echocardiograms cannot be submitted for central read until after Step 1 registration is complete.
  • ✓Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:
  • ✓Serum bilirubin \< 3.0 x institutional upper limit of normal (IULN)
  • ✓Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) \< 5.0 x IULN
  • ✓Patients must not be dialysis dependent
  • ✓No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • ✓Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • ✓Patients must be willing to submit blood specimens
  • ✓Sites must seek additional patient consent for the future use of specimens
  • ✓Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • ✓For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations.
  • ✓As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • ✓STEP 2 REGISTRATION (Randomization)
  • ✓Patients must not be registered to step 2 until confirming via RAVE EDC that the patient's LVEF by echocardiogram was \>= 50% by central review. Patients must be registered within 21 calendar days of submission of the ECHO study/
  • ✓Site must verify that there is no known change in the step 1 eligibility since initial registration

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.