S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer
Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain
About this trial
This is an interventional supportive care trial for Cardiotoxicity
Eligibility Criteria
Inclusion Criteria:
- STEP 1 REGISTRATION
Patients must have metastatic breast cancer and be initiating within 7 days of step 1 registration or continuing trastuzumab?based HER-2 targeted therapy without concurrent anthracyclines in first or second 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
- Trastuzumab + chemotherapy or hormonal therapy
- Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab)
- Ado-trastuzumab (Kadcyla)
- 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:
- Previous anthracycline exposure, OR
1 or more of the following risk factors for heart disease:
- Left ventricular ejection fraction (LVEF) 50-54% by local echocardiography (ECHO) read
- Age >= 65
- Body mass index (BMI) >= 30 kg/m^2
- Current or prior anti-hypertensive therapy
- Diagnosis of coronary artery disease (CAD)
- Diabetes mellitus
- Atrial fibrillation/flutter
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 currently taking a beta blocker, ARB, or ACE inhibitor at the time of step 1 registration are eligible to register for the non-randomized observational cohort (Arm 3)
Patients must not be currently taking or planning to take during study treatment the following medications:
- B2 agonists
- Bosutinib
- Ceritinib
- Floctafenine
- Methacholine
- Pazopanib
- Rivastigmine
- Vincristine
- Silodosin
- 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% by 2-dimensional (D) echocardiogram 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; ECHO should not be submitted for central read until patient has been otherwise deemed eligible
- 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 have electrocardiogram with corrected QT (QTc) with correction within 28 days prior to registration
- Patients must have a systolic blood pressure >= 80 mm Hg within 14 days prior to registration
- Patients must not be dialysis dependent
- Patients must be able to swallow tablets
- Patients must not have uncontrolled asthma
- Patients must not co-enroll on other treatment trials
- 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
- 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 receiving confirmation from the ECHO Core Lab that the patient?s LVEF by echocardiogram was >= 50% by central review; patients must be registered within 5 calendar days of receiving the e-mail notification
- Site must verify that there is no known change in the step 1 eligibility since initial registration
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- CHI Saint Vincent Cancer Center Hot Springs
- Kaiser Permanente-Deer Valley Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Enloe Medical Center
- City of Hope Comprehensive Cancer CenterRecruiting
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- USC / Norris Comprehensive Cancer CenterRecruiting
- Contra Costa Regional Medical CenterRecruiting
- City of Hope Mission HillsRecruiting
- Kaiser Permanente-Modesto
- City of Hope Newport BeachRecruiting
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- City of Hope South PasadenaRecruiting
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- City of Hope South BayRecruiting
- City of Hope UplandRecruiting
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- SCL Health Saint Joseph Hospital
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center
- Good Samaritan Medical Center
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- Middlesex Hospital
- Stamford Hospital/Bennett Cancer Center
- Bayhealth Hospital Kent CampusRecruiting
- Beebe South Coastal Health CampusRecruiting
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health CampusRecruiting
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- Broward Health Medical Center
- Mount Sinai Medical Center
- Moffitt Cancer CenterRecruiting
- Cleveland Clinic-WestonRecruiting
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's Hospital
- Northside HospitalRecruiting
- John B Amos Cancer Center
- Northeast Georgia Medical Center-GainesvilleRecruiting
- Low Country Cancer Care
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Summit Cancer Care-Candler
- Lewis Hall Singletary Oncology CenterRecruiting
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- John H Stroger Jr Hospital of Cook CountyRecruiting
- University of Illinois
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical CenterRecruiting
- Good Samaritan Regional Health Center
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Franciscan Health IndianapolisRecruiting
- Franciscan Saint Elizabeth Health - Lafayette EastRecruiting
- Franciscan Health MooresvilleRecruiting
- Reid Health
- Union Hospital
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Iowa Lutheran Hospital
- Methodist West Hospital
- Mercy Medical Center-West LakesRecruiting
- Coffeyville Regional Medical Center
- Central Care Cancer Center - Garden City
- Saint Catherine Hospital
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health SystemRecruiting
- University of Kansas Cancer Center-WestRecruiting
- University of Kansas Cancer CenterRecruiting
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Olathe Health Cancer CenterRecruiting
- Menorah Medical Center
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Indian Creek CampusRecruiting
- Saint Luke's South Hospital
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital EastRecruiting
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North ClinicRecruiting
- Louisiana Hematology Oncology Associates LLCRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- Ochsner Health Center-Summa
- Our Lady of the Lake Physicians Group - Medical OncologyRecruiting
- Medical Center of Baton Rouge
- Louisiana Hematology Oncology AssociatesRecruiting
- Our Lady of the Lake Medical OncologyRecruiting
- Woman's HospitalRecruiting
- Ochsner Hematology Oncology North Shore - Covington (West Region)
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- UM Upper Chesapeake Medical CenterRecruiting
- Lahey Hospital and Medical CenterRecruiting
- Winchester HospitalRecruiting
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle Creek
- McLaren Cancer Institute-Bay CityRecruiting
- McLaren Cancer Institute-Bloomfield
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Henry Ford Cancer Institute-DownriverRecruiting
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- McLaren Cancer Institute-ClarkstonRecruiting
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute-FlintRecruiting
- Singh and Arora Hematology Oncology PCRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids Hospital
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- McLaren Cancer Institute-MacombRecruiting
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Ascension Providence Hospitals - Novi
- Henry Ford Medical Center-ColumbusRecruiting
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West Branch
- University of Michigan Health - West
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy HospitalRecruiting
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - Healtheast
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners Inc
- Monticello Cancer CenterRecruiting
- New Ulm Medical Center
- North Memorial Medical Health Center
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-Grenada
- University of Mississippi Medical CenterRecruiting
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Singing River Hospital
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical CenterRecruiting
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest CampusRecruiting
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical CentersRecruiting
- Saint Luke's Hospital of Kansas City
- Research Medical Center
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- Saint Luke's East - Lee's Summit
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Washington University School of Medicine
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South County
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Morristown Medical CenterRecruiting
- Newton Medical Center
- Robert Wood Johnson University Hospital Somerset
- Overlook HospitalRecruiting
- Holy Name HospitalRecruiting
- University of New Mexico Cancer CenterRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Nyack HospitalRecruiting
- Stony Brook University Medical Center
- Dickstein Cancer Treatment CenterRecruiting
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Cleveland Clinic Akron GeneralRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Indu and Raj Soin Medical Center
- Aultman Health FoundationRecruiting
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga HospitalRecruiting
- The Christ HospitalRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve UniversityRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Mercy Cancer Center-Elyria
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Cleveland Clinic Cancer Center IndependenceRecruiting
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- North Coast Cancer CareRecruiting
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- University Hospitals Sharon Health CenterRecruiting
- South Pointe HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- UHHS-Westlake Medical CenterRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente NorthwestRecruiting
- Oregon Health and Science UniversityRecruiting
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Bryn Mawr Hospital
- Christiana Care Health System-Concord Health Center
- Pocono Medical Center
- Lehigh Valley Hospital-Hazleton
- Penn State Milton S Hershey Medical CenterRecruiting
- Riddle Memorial Hospital
- Paoli Memorial Hospital
- Phoenixville Hospital
- Guthrie Medical Group PC-Robert Packer HospitalRecruiting
- Lankenau Medical Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Laurens
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - ButternutRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - EastsideRecruiting
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Baptist Memorial Hospital and Cancer Center-Collierville
- Pulmonary Medicine Center of Chattanooga-Hixson
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Baptist Memorial Hospital for Women
- Memorial GYN Plus
- Saint Joseph Regional Cancer Center
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- UT Southwestern/Simmons Cancer Center-Fort WorthRecruiting
- UMC Cancer Center / UMC Health System
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- University Hospital
- University of Texas Health Science Center at San Antonio
- Augusta Health Center for Cancer and Blood DisordersRecruiting
- Providence Regional Cancer System-Aberdeen
- MultiCare Auburn Medical Center
- Virginia Mason Bainbridge Island Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Virginia Mason Federal Way Medical Center
- Saint Francis Hospital
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and Oncology
- Northwest Cancer Clinic
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Virginia Mason Lynnwood Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Peninsula Cancer Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Valley Medical Center
- Virginia Mason Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- FHCC South Lake UnionRecruiting
- Kaiser Permanente Washington
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First HillRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Tacoma/Valley Radiation Oncology Centers-Jackson Hall
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- WVUH-Berkely Medical CenterRecruiting
- West Virginia University HealthcareRecruiting
- Camden Clark Medical CenterRecruiting
- Wheeling Hospital/Schiffler Cancer CenterRecruiting
- Duluth Clinic Ashland
- Bellin Memorial Hospital
- Mercyhealth Hospital and Cancer Center - Janesville
- Cancer Center of Western Wisconsin
- Billings Clinic-Cody
- Welch Cancer Center
- National Cancer Center-KoreaRecruiting
- Advance Oncology Center
- Doctor's Cancer Center-Arecibo
- Cancer Center-Metro Medical Center Bayamon
- Hematologia Oncologia San Pablo
- HIMA San Pablo Oncologic Hospital
- Doctors Cancer Center
- Instituto Oncologia Moderna Ponce
- San Juan Community Oncology Group
- Primary Care Physician Group
- San Juan City Hospital
- Centro de Hematologia y Oncologia del Sur
- King Faisal Specialist Hospital and Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Arm I (carvedilol)
Arm II (no intervention)
Arm III (observation)
Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol PO BID. Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity.
Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks.
Patients undergo observation for up to 108 weeks.