Last updated on September 2018

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer


Brief description of study

This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.

SECONDARY OBJECTIVES:

I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.

II. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events.

III. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population.

IV. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction.

V. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.

TERTIARY OBJECTIVES:

I. To evaluate the isoleucine (lle) 655 valine (Val) and and alanine (Ala)ll70 proline (Pro) single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of study-defined cardiac dysfunction.

II. To evaluate plasma neuregulin-1 at baseline and over study time as a predictive biomarker of study-defined cardiac dysfunction.

III. To evaluate the feasibility of performing serial left ventricular strain in a National Clinical Trials Network (NCTN) group setting, with the goal of 75% of patients contributing both a baseline and at least one follow-up strain measurement.

IV. To bank blood for future translational medicine studies such as brain natriuretic peptide (BNP), additional SNPs, and high sensitivity troponin.

OUTLINE: Patients are randomized to 1 of 2 arms. Patients taking beta blocker, ARB, or ACE inhibitor at registration are assigned to Arm III.

ARM I: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol orally (PO) twice daily (BID). Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks.

ARM III: Patients undergo observation for up to 108 weeks.

After completion of study, patients are followed up for up to 108 weeks.

Clinical Study Identifier: NCT03418961

Contact Investigators or Research Sites near you

Start Over

SWOG

Portland, OR United States
  Connect »

Alaska Women's Cancer Care

Anchorage, AK United States
  Connect »

Anchorage Oncology Centre

Anchorage, AK United States
  Connect »

Katmai Oncology Group

Anchorage, AK United States
  Connect »

Fairbanks Memorial Hospital

Fairbanks, AK United States
  Connect »

Enloe Medical Center

Chico, CA United States
  Connect »

Epic Care-Dublin

Dublin, CA United States
  Connect »

Bay Area Breast Surgeons Inc

Emeryville, CA United States
  Connect »

Kaiser Permanente-Fremont

Fremont, CA United States
  Connect »

Fresno Cancer Center

Fresno, CA United States
  Connect »

Kaiser Permanente-Fresno

Fresno, CA United States
  Connect »

Kaiser Permanente-Modesto

Modesto, CA United States
  Connect »

Bay Area Tumor Institute

Oakland, CA United States
  Connect »

Kaiser Permanente-Oakland

Oakland, CA United States
  Connect »

Kaiser Permanente-Redwood City

Redwood City, CA United States
  Connect »

Kaiser Permanente-Richmond

Richmond, CA United States
  Connect »

Rohnert Park Cancer Center

Rohnert Park, CA United States
  Connect »

Kaiser Permanente-Roseville

Roseville, CA United States
  Connect »

South Sacramento Cancer Center

Sacramento, CA United States
  Connect »

Kaiser Permanente - Sacramento

Sacramento, CA United States
  Connect »

Kaiser Permanente-San Francisco

San Francisco, CA United States
  Connect »

Kaiser Permanente San Leandro

San Leandro, CA United States
  Connect »

Kaiser Permanente-San Rafael

San Rafael, CA United States
  Connect »

Kaiser San Rafael-Gallinas

San Rafael, CA United States
  Connect »

Kaiser Permanente-Santa Rosa

Santa Rosa, CA United States
  Connect »

Kaiser Permanente Cancer Treatment Center

South San Francisco, CA United States
  Connect »

Kaiser Permanente-South San Francisco

South San Francisco, CA United States
  Connect »

Kaiser Permanente-Stockton

Stockton, CA United States
  Connect »

Kaiser Permanente-Vallejo

Vallejo, CA United States
  Connect »

Kaiser Permanente-Walnut Creek

Walnut Creek, CA United States
  Connect »

Penrose-Saint Francis Healthcare

Colorado Springs, CO United States
  Connect »

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, CO United States
  Connect »

Porter Adventist Hospital

Denver, CO United States
  Connect »

Mercy Medical Center

Durango, CO United States
  Connect »

Southwest Oncology PC

Durango, CO United States
  Connect »

Good Samaritan Medical Center

Lafayette, CO United States
  Connect »

Kaiser Permanente-Rock Creek

Lafayette, CO United States
  Connect »

Saint Anthony Hospital

Lakewood, CO United States
  Connect »

Littleton Adventist Hospital

Littleton, CO United States
  Connect »

Kaiser Permanente-Lone Tree

Lone Tree, CO United States
  Connect »

Longmont United Hospital

Longmont, CO United States
  Connect »

Parker Adventist Hospital

Parker, CO United States
  Connect »

Middlesex Hospital

Middletown, CT United States
  Connect »

Beebe Medical Center

Lewes, DE United States
  Connect »

Beebe Health Campus

Rehoboth Beach, DE United States
  Connect »

Nanticoke Memorial Hospital

Seaford, DE United States
  Connect »

Broward Health Medical Center

Fort Lauderdale, FL United States
  Connect »

Summit Cancer Care-Candler

Savannah, GA United States
  Connect »

Pali Momi Medical Center

'Aiea, HI United States
  Connect »

Hawaii Oncology Inc-POB I

Honolulu, HI United States
  Connect »

Island Urology

Honolulu, HI United States
  Connect »

Queen's Medical Center

Honolulu, HI United States
  Connect »

Straub Clinic and Hospital

Honolulu, HI United States
  Connect »

Hawaii Oncology Inc-Kuakini

Honolulu, HI United States
  Connect »

Kuakini Medical Center

Honolulu, HI United States
  Connect »

Kootenai Medical Center

Coeur d'Alene, ID United States
  Connect »

Kootenai Cancer Center

Post Falls, ID United States
  Connect »

Kootenai Cancer Clinic

Sandpoint, ID United States
  Connect »

Illinois CancerCare-Bloomington

Bloomington, IL United States
  Connect »

Memorial Hospital of Carbondale

Carbondale, IL United States
  Connect »

SIH Cancer Institute

Carterville, IL United States
  Connect »

Illinois CancerCare-Carthage

Carthage, IL United States
  Connect »

Centralia Oncology Clinic

Centralia, IL United States
  Connect »

University of Illinois

Chicago, IL United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Decatur Memorial Hospital

Decatur, IL United States
  Connect »

Crossroads Cancer Center

Effingham, IL United States
  Connect »

Illinois CancerCare-Galesburg

Galesburg, IL United States
  Connect »

Illinois CancerCare-Princeton

Princeton, IL United States
  Connect »

Springfield Clinic

Springfield, IL United States
  Connect »

Memorial Medical Center

Springfield, IL United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Rush-Copley Healthcare Center

Yorkville, IL United States
  Connect »

Franciscan Health Indianapolis

Indianapolis, IN United States
  Connect »

Franciscan Health Mooresville

Mooresville, IN United States
  Connect »

Reid Health

Richmond, IN United States
  Connect »

Union Hospital

Terre Haute, IN United States
  Connect »

Alegent Health Mercy Hospital

Council Bluffs, IA United States
  Connect »

Iowa Methodist Medical Center

Des Moines, IA United States
  Connect »

Broadlawns Medical Center

Des Moines, IA United States
  Connect »

Iowa Lutheran Hospital

Des Moines, IA United States
  Connect »

Methodist West Hospital

West Des Moines, IA United States
  Connect »

Mercy Medical Center-West Lakes

West Des Moines, IA United States
  Connect »

Saint Catherine Hospital

Garden City, KS United States
  Connect »

Hays Medical Center

Hays, KS United States
  Connect »

Olathe Medical Center

Olathe, KS United States
  Connect »

Menorah Medical Center

Overland Park, KS United States
  Connect »

Saint Luke's South Hospital

Overland Park, KS United States
  Connect »

Via Christi Hospital-Pittsburg

Pittsburg, KS United States
  Connect »

Flaget Memorial Hospital

Bardstown, KY United States
  Connect »

Saint Joseph Hospital East

Lexington, KY United States
  Connect »

Saint Joseph London

London, KY United States
  Connect »

Jewish Hospital

Louisville, KY United States
  Connect »

Jewish Hospital Medical Center South

Shepherdsville, KY United States
  Connect »

Ochsner Health Center-Summa

Baton Rouge, LA United States
  Connect »

Medical Center of Baton Rouge

Baton Rouge, LA United States
  Connect »

Ochsner Medical Center Jefferson

New Orleans, LA United States
  Connect »

Winchester Hospital

Winchester, MA United States
  Connect »

Saint Joseph Mercy Hospital

Ann Arbor, MI United States
  Connect »

Bronson Battle Creek

Battle Creek, MI United States
  Connect »

Saint Joseph Mercy Brighton

Brighton, MI United States
  Connect »

Saint Joseph Mercy Canton

Canton, MI United States
  Connect »

Caro Cancer Center

Caro, MI United States
  Connect »

Saint Joseph Mercy Chelsea

Chelsea, MI United States
  Connect »

Henry Ford Hospital

Detroit, MI United States
  Connect »

Hurley Medical Center

Flint, MI United States
  Connect »

Mercy Health Saint Mary's

Grand Rapids, MI United States
  Connect »

Lymphoma Clinic of Michigan

Grosse Pointe Woods, MI United States
  Connect »

Allegiance Health

Jackson, MI United States
  Connect »

Bronson Methodist Hospital

Kalamazoo, MI United States
  Connect »

West Michigan Cancer Center

Kalamazoo, MI United States
  Connect »

Borgess Medical Center

Kalamazoo, MI United States
  Connect »

McLaren-Greater Lansing

Lansing, MI United States
  Connect »

Sparrow Hospital

Lansing, MI United States
  Connect »

Hope Cancer Clinic

Livonia, MI United States
  Connect »

Saint Mary Mercy Hospital

Livonia, MI United States
  Connect »

McLaren Cancer Institute-Macomb

Mount Clemens, MI United States
  Connect »

Mercy Health Mercy Campus

Muskegon, MI United States
  Connect »

Lakeland Hospital Niles

Niles, MI United States
  Connect »

Assarian Cancer Center

Novi, MI United States
  Connect »

Hope Cancer Center

Pontiac, MI United States
  Connect »

Saint Joseph Mercy Oakland

Pontiac, MI United States
  Connect »

Saint Mary's of Michigan

Saginaw, MI United States
  Connect »

Marie Yeager Cancer Center

Saint Joseph, MI United States
  Connect »

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, MI United States
  Connect »

Munson Medical Center

Traverse City, MI United States
  Connect »

Henry Ford West Bloomfield Hospital

West Bloomfield, MI United States
  Connect »

Metro Health Hospital

Wyoming, MI United States
  Connect »

Huron Gastroenterology PC

Ypsilanti, MI United States
  Connect »

Fairview Ridges Hospital

Burnsville, MN United States
  Connect »

Mercy Hospital

Coon Rapids, MN United States
  Connect »

Miller-Dwan Hospital

Duluth, MN United States
  Connect »

Unity Hospital

Fridley, MN United States
  Connect »

Abbott-Northwestern Hospital

Minneapolis, MN United States
  Connect »

Hennepin County Medical Center

Minneapolis, MN United States
  Connect »

Health Partners Inc

Minneapolis, MN United States
  Connect »

New Ulm Medical Center

New Ulm, MN United States
  Connect »

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, MN United States
  Connect »

Regions Hospital

Saint Paul, MN United States
  Connect »

United Hospital

Saint Paul, MN United States
  Connect »

Lakeview Hospital

Stillwater, MN United States
  Connect »

Ridgeview Medical Center

Waconia, MN United States
  Connect »

Rice Memorial Hospital

Willmar, MN United States
  Connect »

Singing River Hospital

Pascagoula, MS United States
  Connect »

Cox Cancer Center Branson

Branson, MO United States
  Connect »

Saint Francis Medical Center

Cape Girardeau, MO United States
  Connect »

Southeast Cancer Center

Cape Girardeau, MO United States
  Connect »

Centerpoint Medical Center LLC

Independence, MO United States
  Connect »

Capital Region Southwest Campus

Jefferson City, MO United States
  Connect »

Freeman Health System

Joplin, MO United States
  Connect »

Mercy Hospital Joplin

Joplin, MO United States
  Connect »

Truman Medical Center

Kansas City, MO United States
  Connect »

Research Medical Center

Kansas City, MO United States
  Connect »

Saint Luke's East - Lee's Summit

Lee's Summit, MO United States
  Connect »

Heartland Regional Medical Center

Saint Joseph, MO United States
  Connect »

Missouri Baptist Medical Center

Saint Louis, MO United States
  Connect »

Mercy Hospital Saint Louis

Saint Louis, MO United States
  Connect »

Mercy Hospital Springfield

Springfield, MO United States
  Connect »

CoxHealth South Hospital

Springfield, MO United States
  Connect »

Mercy Hospital Washington

Washington, MO United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

Great Falls Clinic

Great Falls, MT United States
  Connect »

Community Medical Hospital

Missoula, MT United States
  Connect »

CHI Health Saint Francis

Grand Island, NE United States
  Connect »

CHI Health Good Samaritan

Kearney, NE United States
  Connect »

Midlands Community Hospital

Papillion, NE United States
  Connect »

Morristown Medical Center

Morristown, NJ United States
  Connect »

Newton Memorial Hospital

Newton, NJ United States
  Connect »

Overlook Hospital

Summit, NJ United States
  Connect »

Nyack Hospital

Nyack, NY United States
  Connect »

Wayne Memorial Hospital

Goldsboro, NC United States
  Connect »

Onslow Memorial Hospital

Jacksonville, NC United States
  Connect »

Indu and Raj Soin Medical Center

Beavercreek, OH United States
  Connect »

Aultman Health Foundation

Canton, OH United States
  Connect »

Miami Valley Hospital South

Centerville, OH United States
  Connect »

Geauga Hospital

Chardon, OH United States
  Connect »

Bethesda North Hospital

Cincinnati, OH United States
  Connect »

Miami Valley Hospital

Dayton, OH United States
  Connect »

Armes Family Cancer Center

Findlay, OH United States
  Connect »

Blanchard Valley Hospital

Findlay, OH United States
  Connect »

Orion Cancer Care

Findlay, OH United States
  Connect »

Dayton Physicians LLC-Atrium

Franklin, OH United States
  Connect »

Dayton Physicians LLC-Wayne

Greenville, OH United States
  Connect »

Wayne Hospital

Greenville, OH United States
  Connect »

Greater Dayton Cancer Center

Kettering, OH United States
  Connect »

First Dayton Cancer Care

Kettering, OH United States
  Connect »

Kettering Medical Center

Kettering, OH United States
  Connect »

UHHS-Westlake Medical Center

Westlake, OH United States
  Connect »

Mercy Hospital Oklahoma City

Oklahoma City, OK United States
  Connect »

Bay Area Hospital

Coos Bay, OR United States
  Connect »

Kaiser Permanente Northwest

Portland, OR United States
  Connect »

Bryn Mawr Hospital

Bryn Mawr, PA United States
  Connect »

Pocono Medical Center

East Stroudsburg, PA United States
  Connect »

Riddle Memorial Hospital

Media, PA United States
  Connect »

Paoli Memorial Hospital

Paoli, PA United States
  Connect »

Phoenixville Hospital

Phoenixville, PA United States
  Connect »

Lankenau Medical Center

Wynnewood, PA United States
  Connect »

Greenville Memorial Hospital

Greenville, SC United States
  Connect »

Self Regional Healthcare

Greenwood, SC United States
  Connect »

Memorial Hospital

Chattanooga, TN United States
  Connect »

Memorial GYN Plus

Ooltewah, TN United States
  Connect »

University Hospital

San Antonio, TX United States
  Connect »

Harrison Medical Center

Bremerton, WA United States
  Connect »

Saint Elizabeth Hospital

Enumclaw, WA United States
  Connect »

Saint Francis Hospital

Federal Way, WA United States
  Connect »

Northwest Cancer Clinic

Kennewick, WA United States
  Connect »

Saint Clare Hospital

Lakewood, WA United States
  Connect »

Jefferson Healthcare

Port Townsend, WA United States
  Connect »

Peninsula Cancer Center

Poulsbo, WA United States
  Connect »

Valley Medical Center

Renton, WA United States
  Connect »

Duluth Clinic Ashland

Ashland, WI United States
  Connect »

Bellin Memorial Hospital

Green Bay, WI United States
  Connect »

Mercy Health System

Janesville, WI United States
  Connect »

Cancer Center of Western Wisconsin

New Richmond, WI United States
  Connect »

Billings Clinic-Cody

Cody, WY United States
  Connect »

Welch Cancer Center

Sheridan, WY United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.