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

Prospective Observational Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiotoxicity; Recurrent Breast Carcinoma; HER2/Neu Positive; Metastatic Malignant Neoplasm in the Brain; Stage IV Breast Cancer AJCC v6 and v7
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Patient Observation; Drug: Carvedilol

Detailed Description

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 the risk of cardiac dysfunction and/or predefined cardiac events in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy.

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

III. To compare the local and central reads of left ventricular ejection fraction (LVEF) and strain and assess if strain changes can predict drop in ejection fraction.

IV. Assess if strain can be used in the community as a marker of cardiotoxicity.

TERTIARY OBJECTIVES:

I. To evaluate the lle655Val and Alall70Pro single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of study-defined cardiac dysfunction and/or predefined cardiac events.

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

III. To evaluate the feasibility of local labs performing serial left ventricular strain in an 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.

• Study Type: Interventional
• Enrollment (Estimated): 491
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Aguadilla, Puerto Rico, 00603
    • Active, not recruiting
    • Advance Oncology Center
  • Arecibo, Puerto Rico, 00614
    • Active, not recruiting
    • Doctor's Cancer Center-Arecibo
  • Bayamón, Puerto Rico, 00959-5060
    • Active, not recruiting
    • Cancer Center-Metro Medical Center Bayamon
  • Bayamón, Puerto Rico, 00961
    • Active, not recruiting
    • Hematologia Oncologia San Pablo
  • Caguas, Puerto Rico, 00726
    • Active, not recruiting
    • HIMA San Pablo Oncologic Hospital
  • Manatí, Puerto Rico, 00674
    • Active, not recruiting
    • Doctors Cancer Center
  • Ponce, Puerto Rico, 00716
    • Active, not recruiting
    • Instituto Oncologia Moderna Ponce
  • San Juan, Puerto Rico, 00917
    • Active, not recruiting
    • San Juan Community Oncology Group
  • San Juan, Puerto Rico, 00920
    • Active, not recruiting
    • Primary Care Physician Group
  • San Juan, Puerto Rico, 00936
    • Active, not recruiting
    • San Juan City Hospital
  • Santa Isabel, Puerto Rico, 00757
    • Active, not recruiting
    • Centro de Hematologia y Oncologia del Sur
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • Active, not recruiting
    • King Faisal Specialist Hospital and Research Centre
• South Korea
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 410-769
      • Recruiting
      • National Cancer Center-Korea
      • Principal Investigator: Keun Seok Lee
      • Contact: Site Public Contact; Phone Number: 82-31-920-1934
• United States
  • Alaska
    • Anchorage, Alaska, United States, 98508
      • Suspended
      • Anchorage Associates in Radiation Medicine
    • Anchorage, Alaska, United States, 99508
      • Suspended
      • Alaska Breast Care and Surgery LLC
    • Anchorage, Alaska, United States, 99508
      • Suspended
      • Alaska Oncology and Hematology LLC
    • Anchorage, Alaska, United States, 99508
      • Suspended
      • Alaska Women's Cancer Care
    • Anchorage, Alaska, United States, 99508
      • Suspended
      • Anchorage Oncology Centre
    • Anchorage, Alaska, United States, 99508
      • Suspended
      • Katmai Oncology Group
    • Anchorage, Alaska, United States, 99508
      • Suspended
      • Providence Alaska Medical Center
    • Fairbanks, Alaska, United States, 99701
      • Suspended
      • Fairbanks Memorial Hospital
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Suspended
      • CHI Saint Vincent Cancer Center Hot Springs
  • California
    • Antioch, California, United States, 94531
      • Active, not recruiting
      • Kaiser Permanente-Deer Valley Medical Center
    • Burbank, California, United States, 91505
      • Suspended
      • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    • Chico, California, United States, 95926
      • Active, not recruiting
      • Enloe Medical Center
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Comprehensive Cancer Center
      • Contact: Site Public Contact; Phone Number: 800-826-4673; Email: becomingapatient@coh.org
      • Principal Investigator: Joanne E. Mortimer
    • Dublin, California, United States, 94568
      • Suspended
      • Epic Care-Dublin
    • Emeryville, California, United States, 94608
      • Suspended
      • Bay Area Breast Surgeons Inc
    • Emeryville, California, United States, 94608
      • Suspended
      • Epic Care Partners in Cancer Care
    • Fremont, California, United States, 94538
      • Active, not recruiting
      • Kaiser Permanente-Fremont
    • Fresno, California, United States, 93720
      • Active, not recruiting
      • Kaiser Permanente-Fresno
    • Fresno, California, United States, 93720
      • Active, not recruiting
      • Fresno Cancer Center
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Principal Investigator: Priya Jayachandran
      • Contact: Site Public Contact; Phone Number: 323-865-0451
    • Martinez, California, United States, 94553-3156
      • Recruiting
      • Contra Costa Regional Medical Center
      • Principal Investigator: Lisa Bailey
      • Contact: Site Public Contact; Phone Number: 925-957-5400
    • Mission Hills, California, United States, 91345
      • Recruiting
      • City of Hope Mission Hills
      • Contact: Site Public Contact; Phone Number: 800-826-4673; Email: becomingapatient@coh.org
      • Principal Investigator: Joanne E. Mortimer
    • Modesto, California, United States, 95356
      • Active, not recruiting
      • Kaiser Permanente-Modesto
    • Newport Beach, California, United States, 92660
      • Recruiting
      • City of Hope Newport Beach
      • Contact: Site Public Contact; Phone Number: 877-467-3411
      • Principal Investigator: Joanne E. Mortimer
    • Oakland, California, United States, 94609
      • Suspended
      • Bay Area Tumor Institute
    • Oakland, California, United States, 94609
      • Active, not recruiting
      • Alta Bates Summit Medical Center - Summit Campus
    • Oakland, California, United States, 94611
      • Active, not recruiting
      • Kaiser Permanente Oakland-Broadway
    • Oakland, California, United States, 94611
      • Active, not recruiting
      • Kaiser Permanente-Oakland
    • Rancho Cordova, California, United States, 95670
      • Active, not recruiting
      • Kaiser Permanente-Rancho Cordova Cancer Center
    • Redwood City, California, United States, 94063
      • Active, not recruiting
      • Kaiser Permanente-Redwood City
    • Richmond, California, United States, 94801
      • Active, not recruiting
      • Kaiser Permanente-Richmond
    • Rohnert Park, California, United States, 94928
      • Active, not recruiting
      • Rohnert Park Cancer Center
    • Roseville, California, United States, 95678
      • Active, not recruiting
      • The Permanente Medical Group-Roseville Radiation Oncology
    • Roseville, California, United States, 95661
      • Active, not recruiting
      • Kaiser Permanente-Roseville
    • Sacramento, California, United States, 95817
      • Active, not recruiting
      • University of California Davis Comprehensive Cancer Center
    • Sacramento, California, United States, 95823
      • Active, not recruiting
      • Kaiser Permanente-South Sacramento
    • Sacramento, California, United States, 95823
      • Active, not recruiting
      • South Sacramento Cancer Center
    • Sacramento, California, United States, 95825
      • Active, not recruiting
      • Kaiser Permanente - Sacramento
    • San Francisco, California, United States, 94115
      • Active, not recruiting
      • Kaiser Permanente-San Francisco
    • San Jose, California, United States, 95119
      • Active, not recruiting
      • Kaiser Permanente-Santa Teresa-San Jose
    • San Leandro, California, United States, 94577
      • Active, not recruiting
      • Kaiser Permanente San Leandro
    • San Rafael, California, United States, 94903
      • Active, not recruiting
      • Kaiser Permanente-San Rafael
    • San Rafael, California, United States, 94903
      • Active, not recruiting
      • Kaiser San Rafael-Gallinas
    • Santa Clara, California, United States, 95051
      • Active, not recruiting
      • Kaiser Permanente Medical Center - Santa Clara
    • Santa Rosa, California, United States, 95403
      • Active, not recruiting
      • Kaiser Permanente-Santa Rosa
    • South Pasadena, California, United States, 91030
      • Recruiting
      • City of Hope South Pasadena
      • Contact: Site Public Contact; Phone Number: 800-826-4673; Email: becomingapatient@coh.org
      • Principal Investigator: Joanne E. Mortimer
    • South San Francisco, California, United States, 94080
      • Active, not recruiting
      • Kaiser Permanente Cancer Treatment Center
    • South San Francisco, California, United States, 94080
      • Active, not recruiting
      • Kaiser Permanente-South San Francisco
    • Stockton, California, United States, 95210
      • Active, not recruiting
      • Kaiser Permanente-Stockton
    • Torrance, California, United States, 90503
      • Recruiting
      • City of Hope South Bay
      • Contact: Site Public Contact; Phone Number: 877-467-3411
      • Principal Investigator: Joanne E. Mortimer
    • Upland, California, United States, 91786
      • Recruiting
      • City of Hope Upland
      • Contact: Site Public Contact; Phone Number: 800-826-4673; Email: becomingapatient@coh.org
      • Principal Investigator: Joanne E. Mortimer
    • Vacaville, California, United States, 95688
      • Active, not recruiting
      • Kaiser Permanente Medical Center-Vacaville
    • Vallejo, California, United States, 94589
      • Active, not recruiting
      • Kaiser Permanente-Vallejo
    • Walnut Creek, California, United States, 94596
      • Active, not recruiting
      • Kaiser Permanente-Walnut Creek
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Suspended
      • Penrose-Saint Francis Healthcare
    • Colorado Springs, Colorado, United States, 80907
      • Suspended
      • Rocky Mountain Cancer Centers-Penrose
    • Denver, Colorado, United States, 80210
      • Suspended
      • Porter Adventist Hospital
    • Denver, Colorado, United States, 80218
      • Suspended
      • SCL Health Saint Joseph Hospital
    • Denver, Colorado, United States, 80205
      • Suspended
      • Kaiser Permanente-Franklin
    • Durango, Colorado, United States, 81301
      • Suspended
      • Mercy Medical Center
    • Durango, Colorado, United States, 81301
      • Suspended
      • Southwest Oncology PC
    • Golden, Colorado, United States, 80401
      • Suspended
      • Mountain Blue Cancer Care Center
    • Lafayette, Colorado, United States, 80026
      • Suspended
      • Good Samaritan Medical Center
    • Lafayette, Colorado, United States, 80026
      • Suspended
      • Kaiser Permanente-Rock Creek
    • Lakewood, Colorado, United States, 80228
      • Suspended
      • Saint Anthony Hospital
    • Lakewood, Colorado, United States, 80228
      • Suspended
      • Rocky Mountain Cancer Centers-Lakewood
    • Littleton, Colorado, United States, 80122
      • Suspended
      • Littleton Adventist Hospital
    • Lone Tree, Colorado, United States, 80124
      • Suspended
      • Kaiser Permanente-Lone Tree
    • Longmont, Colorado, United States, 80501
      • Suspended
      • Longmont United Hospital
    • Longmont, Colorado, United States, 80501
      • Suspended
      • Rocky Mountain Cancer Centers-Longmont
    • Parker, Colorado, United States, 80138
      • Suspended
      • Rocky Mountain Cancer Centers-Parker
    • Parker, Colorado, United States, 80138
      • Suspended
      • Parker Adventist Hospital
    • Pueblo, Colorado, United States, 81004
      • Suspended
      • Saint Mary Corwin Medical Center
    • Pueblo, Colorado, United States, 81008
      • Suspended
      • Rocky Mountain Cancer Centers - Pueblo
    • Thornton, Colorado, United States, 80260
      • Suspended
      • Rocky Mountain Cancer Centers-Thornton
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Suspended
      • Middlesex Hospital
    • Stamford, Connecticut, United States, 06904
      • Active, not recruiting
      • Stamford Hospital/Bennett Cancer Center
  • Delaware
    • Dover, Delaware, United States, 19901
      • Recruiting
      • Bayhealth Hospital Kent Campus
      • Contact: Site Public Contact; Phone Number: 302-744-6755; Email: mary_ella_quillen@bayhealth.org
      • Principal Investigator: Iftekhar A. Khan
    • Frankford, Delaware, United States, 19945
      • Recruiting
      • Beebe South Coastal Health Campus
      • Contact: Site Public Contact; Phone Number: 302-291-6730; Email: research@beebehealthcare.org
      • Principal Investigator: Gregory A. Masters
    • Lewes, Delaware, United States, 19958
      • Suspended
      • Beebe Medical Center
    • Newark, Delaware, United States, 19713
      • Suspended
      • Delaware Clinical and Laboratory Physicians PA
    • Newark, Delaware, United States, 19718
      • Suspended
      • Christiana Care Health System-Christiana Hospital
    • Newark, Delaware, United States, 19713
      • Suspended
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Suspended
      • Medical Oncology Hematology Consultants PA
    • Rehoboth Beach, Delaware, United States, 19971
      • Recruiting
      • Beebe Health Campus
      • Contact: Site Public Contact; Phone Number: 302-291-6730; Email: research@beebehealthcare.org
      • Principal Investigator: Gregory A. Masters
    • Seaford, Delaware, United States, 19973
      • Suspended
      • TidalHealth Nanticoke / Allen Cancer Center
    • Wilmington, Delaware, United States, 19801
      • Suspended
      • Christiana Care Health System-Wilmington Hospital
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Active, not recruiting
      • Broward Health Medical Center
    • Miami Beach, Florida, United States, 33140
      • Active, not recruiting
      • Mount Sinai Medical Center
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Principal Investigator: Martine Extermann
      • Contact: Site Public Contact; Phone Number: 800-679-0775; Email: ClinicalTrials@moffitt.org
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic-Weston
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 954-659-5705; Email: CancerAnswer@ccf.org
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital/Winship Cancer Institute
      • Principal Investigator: Kevin M. Kalinsky
      • Contact: Site Public Contact; Phone Number: 404-778-1868
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Hospital
      • Principal Investigator: Amelia B. Zelnak
      • Contact: Site Public Contact; Phone Number: 404-303-3355; Email: ClinicalTrials@northside.com
    • Atlanta, Georgia, United States, 30342
      • Suspended
      • Emory Saint Joseph's Hospital
    • Atlanta, Georgia, United States, 30308
      • Suspended
      • Emory University Hospital Midtown
    • Columbus, Georgia, United States, 31904
      • Active, not recruiting
      • John B Amos Cancer Center
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • Northeast Georgia Medical Center-Gainesville
      • Contact: Site Public Contact; Phone Number: 770-219-8800; Email: cancerpatient.navigator@nghs.com
      • Principal Investigator: Charles H. Nash
    • Savannah, Georgia, United States, 31405
      • Recruiting
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Principal Investigator: Alison E. Spellman
      • Contact: Site Public Contact; Phone Number: 912-819-5704; Email: underberga@sjchs.org
    • Savannah, Georgia, United States, 31405
      • Suspended
      • Summit Cancer Care-Candler
    • Savannah, Georgia, United States, 31404
      • Suspended
      • Low Country Cancer Care
    • Thomasville, Georgia, United States, 31792
      • Recruiting
      • Lewis Hall Singletary Oncology Center
      • Contact: Site Public Contact; Phone Number: 888-823-5923; Email: ctsucontact@westat.com
      • Principal Investigator: Josh D. Simmons
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Suspended
      • Island Urology
    • Honolulu, Hawaii, United States, 96813
      • Suspended
      • Hawaii Cancer Care Inc - Waterfront Plaza
    • Honolulu, Hawaii, United States, 96813
      • Suspended
      • Queen's Cancer Cenrer - POB I
    • Honolulu, Hawaii, United States, 96813
      • Suspended
      • Queen's Medical Center
    • Honolulu, Hawaii, United States, 96813
      • Suspended
      • Straub Clinic and Hospital
    • Honolulu, Hawaii, United States, 96813
      • Suspended
      • University of Hawaii Cancer Center
    • Honolulu, Hawaii, United States, 96817
      • Suspended
      • Hawaii Cancer Care Inc-Liliha
    • Honolulu, Hawaii, United States, 96817
      • Suspended
      • Kuakini Medical Center
    • Honolulu, Hawaii, United States, 96817
      • Suspended
      • Queen's Cancer Center - Kuakini
    • Honolulu, Hawaii, United States, 96817
      • Suspended
      • The Cancer Center of Hawaii-Liliha
    • Honolulu, Hawaii, United States, 96826
      • Suspended
      • Kapiolani Medical Center for Women and Children
    • Honolulu, Hawaii, United States, 96819
      • Active, not recruiting
      • Kaiser Permanente Moanalua Medical Center
    • Lihue, Hawaii, United States, 96766
      • Suspended
      • Wilcox Memorial Hospital and Kauai Medical Clinic
    • ‘Aiea, Hawaii, United States, 96701
      • Suspended
      • Queen's Cancer Center - Pearlridge
    • ‘Aiea, Hawaii, United States, 96701
      • Suspended
      • The Cancer Center of Hawaii-Pali Momi
    • ‘Aiea, Hawaii, United States, 96701
      • Suspended
      • Pali Momi Medical Center
  • Idaho
    • Boise, Idaho, United States, 83706
      • Recruiting
      • Saint Alphonsus Cancer Care Center-Boise
      • Contact: Site Public Contact; Phone Number: 734-712-3671; Email: stephanie.couch@stjoeshealth.org
      • Principal Investigator: John M. Schallenkamp
    • Boise, Idaho, United States, 83712
      • Suspended
      • Saint Luke's Cancer Institute - Boise
    • Caldwell, Idaho, United States, 83605
      • Suspended
      • Saint Alphonsus Cancer Care Center-Caldwell
    • Coeur d'Alene, Idaho, United States, 83814
      • Suspended
      • Kootenai Health - Coeur d'Alene
    • Emmett, Idaho, United States, 83617
      • Suspended
      • Walter Knox Memorial Hospital
    • Fruitland, Idaho, United States, 83619
      • Suspended
      • Saint Luke's Cancer Institute - Fruitland
    • Meridian, Idaho, United States, 83642
      • Suspended
      • Idaho Urologic Institute-Meridian
    • Meridian, Idaho, United States, 83642
      • Suspended
      • Saint Luke's Cancer Institute - Meridian
    • Nampa, Idaho, United States, 83686
      • Suspended
      • Saint Luke's Cancer Institute - Nampa
    • Nampa, Idaho, United States, 83687
      • Recruiting
      • Saint Alphonsus Cancer Care Center-Nampa
      • Principal Investigator: John M. Schallenkamp
      • Contact: Site Public Contact; Phone Number: 406-969-6060; Email: mccinfo@mtcancer.org
    • Post Falls, Idaho, United States, 83854
      • Suspended
      • Kootenai Clinic Cancer Services - Post Falls
    • Sandpoint, Idaho, United States, 83864
      • Suspended
      • Kootenai Cancer Clinic
    • Twin Falls, Idaho, United States, 83301
      • Suspended
      • Saint Luke's Cancer Institute - Twin Falls
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Suspended
      • Rush - Copley Medical Center
    • Bloomington, Illinois, United States, 61704
      • Suspended
      • Illinois CancerCare-Bloomington
    • Canton, Illinois, United States, 61520
      • Suspended
      • Illinois CancerCare-Canton
    • Carbondale, Illinois, United States, 62902
      • Suspended
      • Memorial Hospital of Carbondale
    • Carterville, Illinois, United States, 62918
      • Suspended
      • SIH Cancer Institute
    • Carthage, Illinois, United States, 62321
      • Suspended
      • Illinois CancerCare-Carthage
    • Centralia, Illinois, United States, 62801
      • Suspended
      • Centralia Oncology Clinic
    • Chicago, Illinois, United States, 60612
      • Active, not recruiting
      • University of Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • John H Stroger Jr Hospital of Cook County
      • Contact: Site Public Contact; Phone Number: 312-864-5204
      • Principal Investigator: Thomas E. Lad
    • Danville, Illinois, United States, 61832
      • Suspended
      • Carle at The Riverfront
    • Decatur, Illinois, United States, 62526
      • Recruiting
      • Decatur Memorial Hospital
      • Principal Investigator: Bryan A. Faller
      • Contact: Site Public Contact; Phone Number: 217-876-4762; Email: morganthaler.jodi@mhsil.com
    • Decatur, Illinois, United States, 62526
      • Suspended
      • Cancer Care Specialists of Illinois - Decatur
    • Effingham, Illinois, United States, 62401
      • Suspended
      • Carle Physician Group-Effingham
    • Effingham, Illinois, United States, 62401
      • Suspended
      • Crossroads Cancer Center
    • Eureka, Illinois, United States, 61530
      • Suspended
      • Illinois CancerCare-Eureka
    • Galesburg, Illinois, United States, 61401
      • Suspended
      • Western Illinois Cancer Treatment Center
    • Galesburg, Illinois, United States, 61401
      • Suspended
      • Illinois CancerCare-Galesburg
    • Kewanee, Illinois, United States, 61443
      • Suspended
      • Illinois CancerCare-Kewanee Clinic
    • Macomb, Illinois, United States, 61455
      • Suspended
      • Illinois CancerCare-Macomb
    • Mattoon, Illinois, United States, 61938
      • Suspended
      • Carle Physician Group-Mattoon/Charleston
    • Maywood, Illinois, United States, 60153
      • Recruiting
      • Loyola University Medical Center
      • Principal Investigator: Shelly S. Lo
      • Contact: Site Public Contact; Phone Number: 708-226-4357
    • Mount Vernon, Illinois, United States, 62864
      • Suspended
      • Good Samaritan Regional Health Center
    • O'Fallon, Illinois, United States, 62269
      • Recruiting
      • Cancer Care Center of O'Fallon
      • Principal Investigator: Bryan A. Faller
      • Contact: Site Public Contact; Phone Number: 217-876-4762; Email: morganthaler.jodi@mhsil.com
    • Ottawa, Illinois, United States, 61350
      • Suspended
      • Illinois CancerCare-Ottawa Clinic
    • Pekin, Illinois, United States, 61554
      • Suspended
      • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
    • Pekin, Illinois, United States, 61554
      • Suspended
      • Illinois CancerCare-Pekin
    • Peoria, Illinois, United States, 61636
      • Suspended
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61615
      • Suspended
      • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
    • Peoria, Illinois, United States, 61637
      • Suspended
      • OSF Saint Francis Medical Center
    • Peoria, Illinois, United States, 61615
      • Suspended
      • Illinois CancerCare-Peoria
    • Peru, Illinois, United States, 61354
      • Suspended
      • Valley Radiation Oncology
    • Peru, Illinois, United States, 61354
      • Suspended
      • Illinois CancerCare-Peru
    • Princeton, Illinois, United States, 61356
      • Suspended
      • Illinois CancerCare-Princeton
    • Springfield, Illinois, United States, 62781
      • Suspended
      • Memorial Medical Center
    • Springfield, Illinois, United States, 62702
      • Suspended
      • Springfield Clinic
    • Springfield, Illinois, United States, 62702
      • Suspended
      • Southern Illinois University School of Medicine
    • Swansea, Illinois, United States, 62226
      • Suspended
      • Southwest Illinois Health Services LLP
    • Urbana, Illinois, United States, 61801
      • Suspended
      • The Carle Foundation Hospital
    • Urbana, Illinois, United States, 61801
      • Suspended
      • Carle Cancer Center
    • Yorkville, Illinois, United States, 60560
      • Suspended
      • Rush-Copley Healthcare Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Recruiting
      • Franciscan Health Indianapolis
      • Principal Investigator: Naveed A. Rana
      • Contact: Site Public Contact; Phone Number: 317-528-7060
    • Lafayette, Indiana, United States, 47905
      • Recruiting
      • Franciscan Saint Elizabeth Health - Lafayette East
      • Principal Investigator: Naveed A. Rana
      • Contact: Site Public Contact; Phone Number: 888-823-5923; Email: ctsucontact@westat.com
    • Mooresville, Indiana, United States, 46158
      • Recruiting
      • Franciscan Health Mooresville
      • Principal Investigator: Naveed A. Rana
      • Contact: Site Public Contact; Phone Number: 317-834-3603
    • Richmond, Indiana, United States, 47374
      • Active, not recruiting
      • Reid Health
    • Terre Haute, Indiana, United States, 47804
      • Suspended
      • Union Hospital
  • Iowa
    • Clive, Iowa, United States, 50325
      • Recruiting
      • Medical Oncology and Hematology Associates-West Des Moines
      • Contact: Site Public Contact; Phone Number: 515-241-3305
      • Principal Investigator: Richard L. Deming
    • Clive, Iowa, United States, 50325
      • Recruiting
      • Mercy Cancer Center-West Lakes
      • Principal Investigator: Richard L. Deming
      • Contact: Site Public Contact; Phone Number: 515-358-6613; Email: cancerresearch@mercydesmoines.org
    • Council Bluffs, Iowa, United States, 51503
      • Suspended
      • Alegent Health Mercy Hospital
    • Creston, Iowa, United States, 50801
      • Suspended
      • Greater Regional Medical Center
    • Des Moines, Iowa, United States, 50314
      • Recruiting
      • Mercy Medical Center - Des Moines
      • Principal Investigator: Richard L. Deming
      • Contact: Site Public Contact; Phone Number: 515-358-6613; Email: cancerresearch@mercydesmoines.org
    • Des Moines, Iowa, United States, 50314
      • Recruiting
      • Mission Cancer and Blood - Laurel
      • Contact: Site Public Contact; Phone Number: 515-241-3305
      • Principal Investigator: Richard L. Deming
    • Des Moines, Iowa, United States, 50314
      • Active, not recruiting
      • Broadlawns Medical Center
    • Des Moines, Iowa, United States, 50309
      • Active, not recruiting
      • Medical Oncology and Hematology Associates-Des Moines
    • Des Moines, Iowa, United States, 50309
      • Active, not recruiting
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50316
      • Active, not recruiting
      • Iowa Lutheran Hospital
    • West Des Moines, Iowa, United States, 50266
      • Recruiting
      • Mercy Medical Center-West Lakes
      • Principal Investigator: Richard L. Deming
      • Contact: Site Public Contact; Phone Number: 515-358-6613; Email: cancerresearch@mercydesmoines.org
    • West Des Moines, Iowa, United States, 50266-7700
      • Active, not recruiting
      • Methodist West Hospital
  • Kansas
    • Coffeyville, Kansas, United States, 67337
      • Suspended
      • Coffeyville Regional Medical Center
    • Garden City, Kansas, United States, 67846
      • Suspended
      • Central Care Cancer Center - Garden City
    • Garden City, Kansas, United States, 67846
      • Suspended
      • Saint Catherine Hospital
    • Great Bend, Kansas, United States, 67530
      • Suspended
      • Central Care Cancer Center - Great Bend
    • Hays, Kansas, United States, 67601
      • Recruiting
      • HaysMed University of Kansas Health System
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 785-623-5774
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Cancer Center
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Kansas City, Kansas, United States, 66112
      • Recruiting
      • University of Kansas Cancer Center-West
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Lenexa, Kansas, United States, 66219
      • Active, not recruiting
      • Kansas Institute of Medicine Cancer and Blood Center
    • Lenexa, Kansas, United States, 66219
      • Active, not recruiting
      • Minimally Invasive Surgery Hospital
    • Olathe, Kansas, United States, 66061
      • Recruiting
      • Olathe Health Cancer Center
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-355-8000; Email: Jeni.wakefield@olathehealth.org
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • University of Kansas Hospital-Indian Creek Campus
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Overland Park, Kansas, United States, 66210
      • Recruiting
      • University of Kansas Cancer Center-Overland Park
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Overland Park, Kansas, United States, 66209
      • Active, not recruiting
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66213
      • Active, not recruiting
      • Saint Luke's South Hospital
    • Pittsburg, Kansas, United States, 66762
      • Suspended
      • Ascension Via Christi - Pittsburg
    • Salina, Kansas, United States, 67401
      • Suspended
      • Salina Regional Health Center
    • Topeka, Kansas, United States, 66606
      • Recruiting
      • University of Kansas Health System Saint Francis Campus
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 785-295-8000
    • Westwood, Kansas, United States, 66205
      • Recruiting
      • University of Kansas Hospital-Westwood Cancer Center
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Suspended
      • Flaget Memorial Hospital
    • Corbin, Kentucky, United States, 40701
      • Suspended
      • Commonwealth Cancer Center-Corbin
    • Lexington, Kentucky, United States, 40504
      • Suspended
      • Saint Joseph Radiation Oncology Resource Center
    • Lexington, Kentucky, United States, 40509
      • Recruiting
      • Saint Joseph Hospital East
      • Principal Investigator: Shahzad Siddique
      • Contact: Site Public Contact; Phone Number: 859-629-7169; Email: ResearchInstituteInquiries@CommonSpirit.org
    • London, Kentucky, United States, 40741
      • Suspended
      • Saint Joseph London
    • Louisville, Kentucky, United States, 40202
      • Suspended
      • Jewish Hospital
    • Louisville, Kentucky, United States, 40215
      • Suspended
      • Saints Mary and Elizabeth Hospital
    • Louisville, Kentucky, United States, 40245
      • Suspended
      • UofL Health Medical Center Northeast
    • Shepherdsville, Kentucky, United States, 40165
      • Suspended
      • Jewish Hospital Medical Center South
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70805
      • Recruiting
      • LSU Health Baton Rouge-North Clinic
      • Contact: Site Public Contact; Phone Number: 225-765-7659; Email: research@ololrmc.com
      • Principal Investigator: Marshall P. Stagg
    • Baton Rouge, Louisiana, United States, 70809
      • Active, not recruiting
      • Ochsner Health Center-Summa
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Our Lady of the Lake Physicians Group - Medical Oncology
      • Contact: Site Public Contact; Phone Number: 225-765-7659; Email: research@ololrmc.com
      • Principal Investigator: Marshall P. Stagg
    • Baton Rouge, Louisiana, United States, 70816
      • Active, not recruiting
      • Medical Center of Baton Rouge
    • Baton Rouge, Louisiana, United States, 70817
      • Recruiting
      • Our Lady of the Lake Medical Oncology
      • Contact: Site Public Contact; Phone Number: 225-765-7659; Email: research@ololrmc.com
      • Principal Investigator: Marshall P. Stagg
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Louisiana Hematology Oncology Associates LLC
      • Contact: Site Public Contact; Phone Number: 225-215-1353; Email: clinicalresearch@marybird.com
      • Principal Investigator: Victor T. Lin
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Mary Bird Perkins Cancer Center
      • Contact: Site Public Contact; Phone Number: 225-215-1353; Email: clinicalresearch@marybird.com
      • Principal Investigator: Victor T. Lin
    • Baton Rouge, Louisiana, United States, 70817
      • Recruiting
      • Louisiana Hematology Oncology Associates
      • Contact: Site Public Contact; Phone Number: 225-215-1353; Email: clinicalresearch@marybird.com
      • Principal Investigator: Victor T. Lin
    • Baton Rouge, Louisiana, United States, 70817
      • Recruiting
      • Woman's Hospital
      • Contact: Site Public Contact; Phone Number: 225-215-1353; Email: Clinicalreserach@marybird.com
      • Principal Investigator: Victor T. Lin
    • Covington, Louisiana, United States, 70433
      • Active, not recruiting
      • Ochsner Hematology Oncology North Shore - Covington (West Region)
    • New Orleans, Louisiana, United States, 70121
      • Active, not recruiting
      • Ochsner Medical Center Jefferson
    • Shreveport, Louisiana, United States, 71103
      • Active, not recruiting
      • LSU Health Sciences Center at Shreveport
  • Maryland
    • Bel Air, Maryland, United States, 21014
      • Recruiting
      • UM Upper Chesapeake Medical Center
      • Contact: Site Public Contact; Phone Number: 443-643-3010
      • Principal Investigator: Ashkan Bahrani
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Lahey Hospital and Medical Center
      • Contact: Site Public Contact; Phone Number: 781-744-3421; Email: lhmc-cancer-clinical-trials@lahey.org
      • Principal Investigator: Andrew Piper-Vallillo
    • Winchester, Massachusetts, United States, 01890
      • Recruiting
      • Winchester Hospital
      • Contact: Site Public Contact; Email: protocols@swog.org
      • Principal Investigator: Andrew Piper-Vallillo
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Recruiting
      • Saint Joseph Mercy Hospital
      • Contact: Site Public Contact; Phone Number: 734-712-7251; Email: MCRCwebsitecontactform@stjoeshealth.org
      • Principal Investigator: Tareq Al baghdadi
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Comprehensive Cancer Center
      • Principal Investigator: Erin F. Cobain
      • Contact: Site Public Contact; Phone Number: 800-865-1125
    • Battle Creek, Michigan, United States, 49017
      • Suspended
      • Bronson Battle Creek
    • Bay City, Michigan, United States, 48706
      • Recruiting
      • McLaren Cancer Institute-Bay City
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Bloomfield, Michigan, United States, 48302
      • Suspended
      • McLaren Cancer Institute-Bloomfield
    • Brighton, Michigan, United States, 48114
      • Suspended
      • Saint Joseph Mercy Brighton
    • Brighton, Michigan, United States, 48114
      • Suspended
      • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    • Brownstown, Michigan, United States, 48183
      • Recruiting
      • Henry Ford Cancer Institute-Downriver
      • Contact: Site Public Contact; Phone Number: 313-916-3721; Email: CTOResearch@hfhs.org
      • Principal Investigator: Haythem Y. Ali
    • Canton, Michigan, United States, 48188
      • Suspended
      • Saint Joseph Mercy Canton
    • Canton, Michigan, United States, 48188
      • Suspended
      • Trinity Health IHA Medical Group Hematology Oncology - Canton
    • Caro, Michigan, United States, 48723
      • Suspended
      • Caro Cancer Center
    • Chelsea, Michigan, United States, 48118
      • Suspended
      • Saint Joseph Mercy Chelsea
    • Chelsea, Michigan, United States, 48118
      • Suspended
      • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
    • Clarkston, Michigan, United States, 48346
      • Suspended
      • Hematology Oncology Consultants-Clarkston
    • Clarkston, Michigan, United States, 48346
      • Suspended
      • Newland Medical Associates-Clarkston
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • McLaren Cancer Institute-Clarkston
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Clinton Township, Michigan, United States, 48038
      • Recruiting
      • Henry Ford Macomb Hospital-Clinton Township
      • Contact: Site Public Contact; Phone Number: 313-916-3721; Email: CTOResearch@hfhs.org
      • Principal Investigator: Haythem Y. Ali
    • Dearborn, Michigan, United States, 48126
      • Recruiting
      • Henry Ford Medical Center-Fairlane
      • Contact: Site Public Contact; Phone Number: 313-916-3721; Email: CTOResearch@hfhs.org
      • Principal Investigator: Haythem Y. Ali
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University/Karmanos Cancer Institute
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Contact: Site Public Contact; Phone Number: 313-916-3721; Email: CTOResearch@hfhs.org
      • Principal Investigator: Haythem Y. Ali
    • Detroit, Michigan, United States, 48236
      • Suspended
      • Ascension Saint John Hospital
    • East China Township, Michigan, United States, 48054
      • Suspended
      • Great Lakes Cancer Management Specialists-Doctors Park
    • Flint, Michigan, United States, 48532
      • Recruiting
      • McLaren Cancer Institute-Flint
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Flint, Michigan, United States, 48532
      • Recruiting
      • Singh and Arora Hematology Oncology PC
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Flint, Michigan, United States, 48503
      • Suspended
      • Hurley Medical Center
    • Flint, Michigan, United States, 48503
      • Suspended
      • Genesee Cancer and Blood Disease Treatment Center
    • Flint, Michigan, United States, 48503
      • Suspended
      • Genesee Hematology Oncology PC
    • Flint, Michigan, United States, 48503
      • Suspended
      • Genesys Hurley Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Spectrum Health at Butterworth Campus
      • Contact: Site Public Contact; Phone Number: 616-391-1230; Email: crcwm-regulatory@crcwm.org
      • Principal Investigator: Kathleen J. Yost
    • Grand Rapids, Michigan, United States, 49503
      • Suspended
      • Trinity Health Grand Rapids Hospital
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Suspended
      • Michigan Breast Specialists-Grosse Pointe Woods
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Suspended
      • Academic Hematology Oncology Specialists
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Suspended
      • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
    • Jackson, Michigan, United States, 49201
      • Suspended
      • Allegiance Health
    • Kalamazoo, Michigan, United States, 49048
      • Suspended
      • Borgess Medical Center
    • Kalamazoo, Michigan, United States, 49007
      • Suspended
      • West Michigan Cancer Center
    • Kalamazoo, Michigan, United States, 49007
      • Suspended
      • Bronson Methodist Hospital
    • Lansing, Michigan, United States, 48912
      • Suspended
      • Sparrow Hospital
    • Lansing, Michigan, United States, 48910
      • Recruiting
      • Karmanos Cancer Institute at McLaren Greater Lansing
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Lapeer, Michigan, United States, 48446
      • Recruiting
      • McLaren Cancer Institute-Lapeer Region
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Livonia, Michigan, United States, 48154
      • Suspended
      • Hope Cancer Clinic
    • Livonia, Michigan, United States, 48154
      • Suspended
      • Trinity Health Saint Mary Mercy Livonia Hospital
    • Macomb, Michigan, United States, 48044
      • Suspended
      • Michigan Breast Specialists-Macomb Township
    • Macomb, Michigan, United States, 48044
      • Suspended
      • Great Lakes Cancer Management Specialists-Macomb Medical Campus
    • Marlette, Michigan, United States, 48453
      • Suspended
      • Saint Mary's Oncology/Hematology Associates of Marlette
    • Mount Clemens, Michigan, United States, 48043
      • Recruiting
      • McLaren Cancer Institute-Macomb
      • Principal Investigator: Hadeel Assad
      • Contact: Site Public Contact; Phone Number: 313-576-9790; Email: ctoadmin@karmanos.org
    • Muskegon, Michigan, United States, 49444
      • Suspended
      • Trinity Health Muskegon Hospital
    • Niles, Michigan, United States, 49120
      • Suspended
      • Lakeland Hospital Niles
    • Novi, Michigan, United States, 48377
      • Recruiting
      • Henry Ford Medical Center-Columbus
      • Contact: Site Public Contact; Phone Number: 313-916-3721; Email: CTOResearch@hfhs.org
      • Principal Investigator: Haythem Y. Ali
    • Novi, Michigan, United States, 48374
      • Suspended
      • Ascension Providence Hospitals - Novi
    • Pontiac, Michigan, United States, 48341
      • Suspended
      • 21st Century Oncology-Pontiac
    • Pontiac, Michigan, United States, 48341
      • Suspended
      • Hope Cancer Center
    • Pontiac, Michigan, United States, 48341
      • Suspended
      • Newland Medical Associates-Pontiac
    • Pontiac, Michigan, United States, 48341
      • Suspended
      • Saint Joseph Mercy Oakland
    • Reed City, Michigan, United States, 49677
      • Suspended
      • Spectrum Health Reed City Hospital
    • Rochester Hills, Michigan, United States, 48309
      • Suspended
      • Great Lakes Cancer Management Specialists-Rochester Hills
    • Saginaw, Michigan, United States, 48601
      • Suspended
      • Ascension Saint Mary's Hospital
    • Saginaw, Michigan, United States, 48604
      • Suspended
      • Oncology Hematology Associates of Saginaw Valley PC
    • Saint Joseph, Michigan, United States, 49085
      • Suspended
      • Lakeland Medical Center Saint Joseph
    • Saint Joseph, Michigan, United States, 49085
      • Suspended
      • Marie Yeager Cancer Center
    • Southfield, Michigan, United States, 48075
      • Recruiting
      • Ascension Providence Hospitals - Southfield
      • Contact: Site Public Contact; Phone Number: 248-849-5332; Email: karen.fife@ascension.org
      • Principal Investigator: Cynthia M. Vakhariya
    • Sterling Heights, Michigan, United States, 48312
      • Suspended
      • Bhadresh Nayak MD PC-Sterling Heights
    • Tawas City, Michigan, United States, 48764
      • Suspended
      • Ascension Saint Joseph Hospital
    • Traverse City, Michigan, United States, 49684
      • Suspended
      • Munson Medical Center
    • Warren, Michigan, United States, 48088
      • Suspended
      • Advanced Breast Care Center PLLC
    • Warren, Michigan, United States, 48093
      • Suspended
      • Macomb Hematology Oncology PC
    • Warren, Michigan, United States, 48093
      • Suspended
      • Michigan Breast Specialists-Warren
    • Warren, Michigan, United States, 48093
      • Suspended
      • Great Lakes Cancer Management Specialists-Macomb Professional Building
    • Warren, Michigan, United States, 48093
      • Suspended
      • Saint John Macomb-Oakland Hospital
    • West Bloomfield, Michigan, United States, 48322
      • Recruiting
      • Henry Ford West Bloomfield Hospital
      • Contact: Site Public Contact; Phone Number: 313-916-3721; Email: CTOResearch@hfhs.org
      • Principal Investigator: Haythem Y. Ali
    • West Branch, Michigan, United States, 48661
      • Suspended
      • Saint Mary's Oncology/Hematology Associates of West Branch
    • Wyoming, Michigan, United States, 49519
      • Suspended
      • University of Michigan Health - West
    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
      • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Contact: Site Public Contact; Phone Number: 734-712-7251; Email: MCRCwebsitecontactform@stjoeshealth.org
      • Principal Investigator: Tareq Al baghdadi
    • Ypsilanti, Michigan, United States, 48106
      • Suspended
      • Huron Gastroenterology PC
  • Minnesota
    • Bemidji, Minnesota, United States, 56601
      • Active, not recruiting
      • Sanford Joe Lueken Cancer Center
    • Brainerd, Minnesota, United States, 56401
      • Active, not recruiting
      • Essentia Health Saint Joseph's Medical Center
    • Burnsville, Minnesota, United States, 55337
      • Suspended
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Recruiting
      • Mercy Hospital
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Duluth, Minnesota, United States, 55805
      • Active, not recruiting
      • Essentia Health Cancer Center
    • Duluth, Minnesota, United States, 55805
      • Active, not recruiting
      • Essentia Health Saint Mary's Medical Center
    • Duluth, Minnesota, United States, 55805
      • Active, not recruiting
      • Miller-Dwan Hospital
    • Edina, Minnesota, United States, 55435
      • Suspended
      • Fairview Southdale Hospital
    • Fergus Falls, Minnesota, United States, 56537
      • Active, not recruiting
      • Lake Region Healthcare Corporation-Cancer Care
    • Fridley, Minnesota, United States, 55432
      • Suspended
      • Unity Hospital
    • Hibbing, Minnesota, United States, 55746
      • Active, not recruiting
      • Essentia Health Hibbing Clinic
    • Maple Grove, Minnesota, United States, 55369
      • Suspended
      • Fairview Clinics and Surgery Center Maple Grove
    • Maplewood, Minnesota, United States, 55109
      • Recruiting
      • Minnesota Oncology Hematology PA-Maplewood
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Maplewood, Minnesota, United States, 55109
      • Suspended
      • Saint John's Hospital - Healtheast
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Abbott-Northwestern Hospital
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin County Medical Center
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Minneapolis, Minnesota, United States, 55454
      • Suspended
      • Health Partners Inc
    • Monticello, Minnesota, United States, 55362
      • Recruiting
      • Monticello Cancer Center
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • New Ulm, Minnesota, United States, 56073
      • Suspended
      • New Ulm Medical Center
    • Robbinsdale, Minnesota, United States, 55422
      • Suspended
      • North Memorial Medical Health Center
    • Saint Louis Park, Minnesota, United States, 55416
      • Recruiting
      • Park Nicollet Clinic - Saint Louis Park
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Saint Paul, Minnesota, United States, 55101
      • Recruiting
      • Regions Hospital
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Saint Paul, Minnesota, United States, 55102
      • Recruiting
      • United Hospital
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Shakopee, Minnesota, United States, 55379
      • Suspended
      • Saint Francis Regional Medical Center
    • Stillwater, Minnesota, United States, 55082
      • Suspended
      • Lakeview Hospital
    • Virginia, Minnesota, United States, 55792
      • Active, not recruiting
      • Essentia Health Virginia Clinic
    • Waconia, Minnesota, United States, 55387
      • Suspended
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Suspended
      • Rice Memorial Hospital
    • Woodbury, Minnesota, United States, 55125
      • Recruiting
      • Minnesota Oncology Hematology PA-Woodbury
      • Contact: Site Public Contact; Phone Number: 952-993-1517; Email: mmcorc@healthpartners.com
      • Principal Investigator: David M. King
    • Wyoming, Minnesota, United States, 55092
      • Suspended
      • Fairview Lakes Medical Center
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Recruiting
      • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Principal Investigator: Sailendra Vasireddy
      • Contact: Site Public Contact; Phone Number: 901-226-1366; Email: BCCclintrials@bmhcc.org
    • Grenada, Mississippi, United States, 38901
      • Suspended
      • Baptist Cancer Center-Grenada
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Principal Investigator: Barbara S. Craft
      • Contact: Site Public Contact; Phone Number: 601-815-6700
    • New Albany, Mississippi, United States, 38652
      • Suspended
      • Baptist Memorial Hospital and Cancer Center-Union County
    • Oxford, Mississippi, United States, 38655
      • Suspended
      • Baptist Memorial Hospital and Cancer Center-Oxford
    • Pascagoula, Mississippi, United States, 39581
      • Active, not recruiting
      • Singing River Hospital
    • Southhaven, Mississippi, United States, 38671
      • Suspended
      • Baptist Memorial Hospital and Cancer Center-Desoto
  • Missouri
    • Ballwin, Missouri, United States, 63011
      • Recruiting
      • Saint Louis Cancer and Breast Institute-Ballwin
      • Principal Investigator: Jay W. Carlson
      • Contact: Site Public Contact; Phone Number: 314-251-7058
    • Bolivar, Missouri, United States, 65613
      • Suspended
      • Central Care Cancer Center - Bolivar
    • Bonne Terre, Missouri, United States, 63628
      • Suspended
      • Parkland Health Center-Bonne Terre
    • Branson, Missouri, United States, 65616
      • Suspended
      • Cox Cancer Center Branson
    • Cape Girardeau, Missouri, United States, 63703
      • Recruiting
      • Saint Francis Medical Center
      • Principal Investigator: Bryan A. Faller
      • Contact: Site Public Contact; Phone Number: 573-334-2230; Email: sfmc@sfmc.net
    • Cape Girardeau, Missouri, United States, 63703
      • Suspended
      • Southeast Cancer Center
    • City of Saint Peters, Missouri, United States, 63376
      • Active, not recruiting
      • Siteman Cancer Center at Saint Peters Hospital
    • Creve Coeur, Missouri, United States, 63141
      • Active, not recruiting
      • Siteman Cancer Center at West County Hospital
    • Independence, Missouri, United States, 64057
      • Active, not recruiting
      • Centerpoint Medical Center LLC
    • Jefferson City, Missouri, United States, 65109
      • Recruiting
      • Capital Region Southwest Campus
      • Principal Investigator: Bryan A. Faller
      • Contact: Site Public Contact; Phone Number: 573-632-4814; Email: swooden@mail.crmc.org
    • Joplin, Missouri, United States, 64804
      • Suspended
      • Freeman Health System
    • Joplin, Missouri, United States, 64804
      • Suspended
      • Mercy Hospital Joplin
    • Kansas City, Missouri, United States, 64111
      • Active, not recruiting
      • Saint Luke's Hospital of Kansas City
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Truman Medical Centers
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 816-404-4375
    • Kansas City, Missouri, United States, 64154
      • Recruiting
      • University of Kansas Cancer Center - North
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Kansas City, Missouri, United States, 64132
      • Active, not recruiting
      • Research Medical Center
    • Lee's Summit, Missouri, United States, 64064
      • Recruiting
      • University of Kansas Cancer Center - Lee's Summit
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Lee's Summit, Missouri, United States, 64086
      • Active, not recruiting
      • Saint Luke's East - Lee's Summit
    • North Kansas City, Missouri, United States, 64116
      • Recruiting
      • University of Kansas Cancer Center at North Kansas City Hospital
      • Principal Investigator: Anne P. O'Dea
      • Contact: Site Public Contact; Phone Number: 913-588-3671; Email: KUCC_Navigation@kumc.edu
    • Rolla, Missouri, United States, 65401
      • Suspended
      • Delbert Day Cancer Institute at PCRMC
    • Rolla, Missouri, United States, 65401
      • Suspended
      • Mercy Clinic-Rolla-Cancer and Hematology
    • Saint Joseph, Missouri, United States, 64506
      • Suspended
      • Heartland Regional Medical Center
    • Sainte Genevieve, Missouri, United States, 63670
      • Suspended
      • Sainte Genevieve County Memorial Hospital
    • Springfield, Missouri, United States, 65804
      • Recruiting
      • Mercy Hospital Springfield
      • Principal Investigator: Jay W. Carlson
      • Contact: Site Public Contact; Phone Number: 417-269-4520
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • CoxHealth South Hospital
      • Principal Investigator: Jay W. Carlson
      • Contact: Site Public Contact; Phone Number: 417-269-4520
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63128
      • Recruiting
      • Mercy Hospital South
      • Principal Investigator: Jay W. Carlson
      • Contact: Site Public Contact; Email: janet.lesko@mercy.net
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Mercy Hospital Saint Louis
      • Principal Investigator: Jay W. Carlson
      • Contact: Site Public Contact; Phone Number: 314-251-7066
    • St Louis, Missouri, United States, 63131
      • Recruiting
      • Missouri Baptist Medical Center
      • Principal Investigator: Bryan A. Faller
      • Contact: Site Public Contact; Phone Number: 314-996-5569
    • St Louis, Missouri, United States, 63129
      • Active, not recruiting
      • Siteman Cancer Center-South County
    • St Louis, Missouri, United States, 63136
      • Active, not recruiting
      • Siteman Cancer Center at Christian Hospital
    • St Louis, Missouri, United States, 63109
      • Recruiting
      • Saint Louis Cancer and Breast Institute-South City
      • Principal Investigator: Jay W. Carlson
      • Contact: Site Public Contact; Phone Number: 314-353-1870
    • Sullivan, Missouri, United States, 63080
      • Suspended
      • Missouri Baptist Sullivan Hospital
    • Sunset Hills, Missouri, United States, 63127
      • Suspended
      • Missouri Baptist Outpatient Center-Sunset Hills
    • Washington, Missouri, United States, 63090
      • Suspended
      • Mercy Hospital Washington
  • Montana
    • Anaconda, Montana, United States, 59711
      • Suspended
      • Community Hospital of Anaconda
    • Billings, Montana, United States, 59101
      • Suspended
      • Billings Clinic Cancer Center
    • Bozeman, Montana, United States, 59715
      • Suspended
      • Bozeman Deaconess Hospital
    • Great Falls, Montana, United States, 59405
      • Recruiting
      • Benefis Healthcare- Sletten Cancer Institute
      • Principal Investigator: John M. Schallenkamp
      • Contact: Site Public Contact; Phone Number: 406-969-6060; Email: mccinfo@mtcancer.org
    • Great Falls, Montana, United States, 59405
      • Suspended
      • Great Falls Clinic
    • Helena, Montana, United States, 59601
      • Suspended
      • Saint Peter's Community Hospital
    • Kalispell, Montana, United States, 59901
      • Suspended
      • Kalispell Regional Medical Center
    • Missoula, Montana, United States, 59802
      • Suspended
      • Saint Patrick Hospital - Community Hospital
    • Missoula, Montana, United States, 59804
      • Suspended
      • Community Medical Hospital
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Suspended
      • CHI Health Saint Francis
    • Kearney, Nebraska, United States, 68847
      • Suspended
      • CHI Health Good Samaritan
    • Kearney, Nebraska, United States, 68845
      • Suspended
      • Heartland Hematology and Oncology
    • Lincoln, Nebraska, United States, 68510
      • Suspended
      • Saint Elizabeth Regional Medical Center
    • Omaha, Nebraska, United States, 68122
      • Suspended
      • Alegent Health Immanuel Medical Center
    • Omaha, Nebraska, United States, 68124
      • Suspended
      • Alegent Health Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68130
      • Suspended
      • Alegent Health Lakeside Hospital
    • Omaha, Nebraska, United States, 68131
      • Suspended
      • Creighton University Medical Center
    • Omaha, Nebraska, United States, 68122
      • Suspended
      • Hematology and Oncology Consultants PC
    • Papillion, Nebraska, United States, 68046
      • Suspended
      • Midlands Community Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Morristown Medical Center
      • Principal Investigator: Bonni L. Guerin
      • Contact: Site Public Contact; Phone Number: 973-971-5900
    • Newton, New Jersey, United States, 07860
      • Suspended
      • Newton Medical Center
    • Somerville, New Jersey, United States, 08876
      • Active, not recruiting
      • Robert Wood Johnson University Hospital Somerset
    • Summit, New Jersey, United States, 07902
      • Recruiting
      • Overlook Hospital
      • Principal Investigator: Bonni L. Guerin
      • Contact: Site Public Contact; Phone Number: 908-522-2043
    • Teaneck, New Jersey, United States, 07666
      • Recruiting
      • Holy Name Hospital
      • Contact: Site Public Contact; Phone Number: 201-833-6312
      • Principal Investigator: Yadyra Rivera
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • University of New Mexico Cancer Center
      • Principal Investigator: Jacklyn M. Nemunaitis
      • Contact: Site Public Contact; Phone Number: 505-925-0348; Email: HSC-ClinicalTrialInfo@salud.unm.edu
  • New York
    • New York, New York, United States, 10032
      • Active, not recruiting
      • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    • Nyack, New York, United States, 10960
      • Recruiting
      • Nyack Hospital
      • Contact: Site Public Contact; Phone Number: 845-348-8507
      • Principal Investigator: Sung Ho B. Lee
    • Stony Brook, New York, United States, 11794
      • Active, not recruiting
      • Stony Brook University Medical Center
    • White Plains, New York, United States, 10601
      • Recruiting
      • Dickstein Cancer Treatment Center
      • Contact: Site Public Contact; Phone Number: 914-849-7582; Email: mcortese@wphospital.org
      • Principal Investigator: Dan Costin
  • North Carolina
    • Clinton, North Carolina, United States, 28328
      • Active, not recruiting
      • Southeastern Medical Oncology Center-Clinton
    • Goldsboro, North Carolina, United States, 27534
      • Active, not recruiting
      • Wayne Memorial Hospital
    • Goldsboro, North Carolina, United States, 27534
      • Active, not recruiting
      • Southeastern Medical Oncology Center-Goldsboro
    • Jacksonville, North Carolina, United States, 28546
      • Active, not recruiting
      • Onslow Memorial Hospital
    • Jacksonville, North Carolina, United States, 28546
      • Active, not recruiting
      • Southeastern Medical Oncology Center-Jacksonville
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Active, not recruiting
      • Sanford Bismarck Medical Center
    • Fargo, North Dakota, United States, 58103
      • Active, not recruiting
      • Essentia Health Cancer Center-South University Clinic
    • Fargo, North Dakota, United States, 58122
      • Active, not recruiting
      • Sanford Broadway Medical Center
    • Fargo, North Dakota, United States, 58122
      • Active, not recruiting
      • Sanford Roger Maris Cancer Center
  • Ohio
    • Akron, Ohio, United States, 44307
      • Recruiting
      • Cleveland Clinic Akron General
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: CancerAnswer@ccf.org
      • Principal Investigator: Kathryn M. Leininger
    • Beachwood, Ohio, United States, 44122
      • Recruiting
      • UHHS-Chagrin Highlands Medical Center
      • Principal Investigator: Bahar Moftakhar
      • Contact: Site Public Contact; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
    • Beavercreek, Ohio, United States, 45431
      • Active, not recruiting
      • Indu and Raj Soin Medical Center
    • Canton, Ohio, United States, 44710
      • Recruiting
      • Aultman Health Foundation
      • Contact: Site Public Contact; Phone Number: 330-363-7274; Email: ClinicalReserachDept@aultman.com
      • Principal Investigator: Sunitha Vemulapalli
    • Centerville, Ohio, United States, 45459
      • Active, not recruiting
      • Miami Valley Hospital South
    • Centerville, Ohio, United States, 45459
      • Active, not recruiting
      • Dayton Physicians LLC-Miami Valley South
    • Chardon, Ohio, United States, 44024
      • Recruiting
      • Geauga Hospital
      • Principal Investigator: Bahar Moftakhar
      • Contact: Site Public Contact; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Cancer Center-UC Medical Center
      • Principal Investigator: Mahmoud Charif
      • Contact: Site Public Contact; Phone Number: 513-584-7698; Email: cancer@uchealth.com
    • Cincinnati, Ohio, United States, 45220
      • Suspended
      • Good Samaritan Hospital - Cincinnati
    • Cincinnati, Ohio, United States, 45242
      • Suspended
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45247
      • Suspended
      • TriHealth Cancer Institute-Westside
    • Cincinnati, Ohio, United States, 45255
      • Suspended
      • TriHealth Cancer Institute-Anderson
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital
      • Contact: Site Public Contact; Phone Number: 513-585-0844
      • Principal Investigator: Gina G. Chung
    • Cincinnati, Ohio, United States, 45236
      • Active, not recruiting
      • Oncology Hematology Care Inc-Kenwood
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western Reserve University
      • Principal Investigator: Bahar Moftakhar
      • Contact: Site Public Contact; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
    • Cleveland, Ohio, United States, 44111
      • Recruiting
      • Cleveland Clinic Cancer Center/Fairview Hospital
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Dayton, Ohio, United States, 45406
      • Suspended
      • Good Samaritan Hospital - Dayton
    • Dayton, Ohio, United States, 45409
      • Active, not recruiting
      • Miami Valley Hospital
    • Dayton, Ohio, United States, 45415
      • Active, not recruiting
      • Miami Valley Hospital North
    • Dayton, Ohio, United States, 45415
      • Active, not recruiting
      • Dayton Physician LLC-Miami Valley Hospital North
    • Elyria, Ohio, United States, 44035
      • Suspended
      • Mercy Cancer Center-Elyria
    • Findlay, Ohio, United States, 45840
      • Active, not recruiting
      • Armes Family Cancer Center
    • Findlay, Ohio, United States, 45840
      • Active, not recruiting
      • Blanchard Valley Hospital
    • Findlay, Ohio, United States, 45840
      • Active, not recruiting
      • Orion Cancer Care
    • Franklin, Ohio, United States, 45005-1066
      • Active, not recruiting
      • Atrium Medical Center-Middletown Regional Hospital
    • Franklin, Ohio, United States, 45005
      • Active, not recruiting
      • Dayton Physicians LLC-Atrium
    • Greenville, Ohio, United States, 45331
      • Active, not recruiting
      • Dayton Physicians LLC-Wayne
    • Greenville, Ohio, United States, 45331
      • Active, not recruiting
      • Wayne Hospital
    • Independence, Ohio, United States, 44131
      • Recruiting
      • Cleveland Clinic Cancer Center Independence
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Kettering, Ohio, United States, 45409
      • Active, not recruiting
      • Greater Dayton Cancer Center
    • Kettering, Ohio, United States, 45420
      • Active, not recruiting
      • First Dayton Cancer Care
    • Kettering, Ohio, United States, 45429
      • Active, not recruiting
      • Kettering Medical Center
    • Mansfield, Ohio, United States, 44906
      • Recruiting
      • Cleveland Clinic Cancer Center Mansfield
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Hillcrest Hospital Cancer Center
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Mentor, Ohio, United States, 44060
      • Suspended
      • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Middleburg Heights, Ohio, United States, 44130
      • Suspended
      • UH Seidman Cancer Center at Southwest General Hospital
    • Sandusky, Ohio, United States, 44870
      • Recruiting
      • North Coast Cancer Care
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Springfield, Ohio, United States, 45504
      • Active, not recruiting
      • Springfield Regional Cancer Center
    • Springfield, Ohio, United States, 45505
      • Active, not recruiting
      • Springfield Regional Medical Center
    • Strongsville, Ohio, United States, 44136
      • Recruiting
      • Cleveland Clinic Cancer Center Strongsville
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • Troy, Ohio, United States, 45373
      • Active, not recruiting
      • Upper Valley Medical Center
    • Troy, Ohio, United States, 45373
      • Active, not recruiting
      • Dayton Physicians LLC - Troy
    • Wadsworth, Ohio, United States, 44281
      • Recruiting
      • University Hospitals Sharon Health Center
      • Principal Investigator: Bahar Moftakhar
      • Contact: Site Public Contact; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
    • Warrensville Heights, Ohio, United States, 44122
      • Recruiting
      • South Pointe Hospital
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
    • West Chester, Ohio, United States, 45069
      • Recruiting
      • University of Cincinnati Cancer Center-West Chester
      • Principal Investigator: Mahmoud Charif
      • Contact: Site Public Contact; Phone Number: 513-584-7698; Email: cancer@uchealth.com
    • Westlake, Ohio, United States, 44145
      • Recruiting
      • UH Seidman Cancer Center at Saint John Medical Center
      • Principal Investigator: Bahar Moftakhar
      • Contact: Site Public Contact; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
    • Westlake, Ohio, United States, 44145
      • Recruiting
      • UHHS-Westlake Medical Center
      • Principal Investigator: Bahar Moftakhar
      • Contact: Site Public Contact; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
    • Wooster, Ohio, United States, 44691
      • Recruiting
      • Cleveland Clinic Wooster Family Health and Surgery Center
      • Principal Investigator: Halle C. Moore
      • Contact: Site Public Contact; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Suspended
      • Mercy Hospital Oklahoma City
    • Oklahoma City, Oklahoma, United States, 73104
      • Active, not recruiting
      • University of Oklahoma Health Sciences Center
    • Tulsa, Oklahoma, United States, 74146
      • Active, not recruiting
      • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Oregon
    • Baker City, Oregon, United States, 97814
      • Suspended
      • Saint Alphonsus Medical Center-Baker City
    • Bend, Oregon, United States, 97701
      • Suspended
      • Saint Charles Health System
    • Clackamas, Oregon, United States, 97015
      • Suspended
      • Clackamas Radiation Oncology Center
    • Clackamas, Oregon, United States, 97015
      • Suspended
      • Providence Cancer Institute Clackamas Clinic
    • Coos Bay, Oregon, United States, 97420
      • Suspended
      • Bay Area Hospital
    • Newberg, Oregon, United States, 97132
      • Suspended
      • Providence Newberg Medical Center
    • Ontario, Oregon, United States, 97914
      • Suspended
      • Saint Alphonsus Medical Center-Ontario
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
      • Principal Investigator: Alexandra d. Zimmer
      • Contact: Site Public Contact; Phone Number: 503-494-1080; Email: trials@ohsu.edu
    • Portland, Oregon, United States, 97227
      • Recruiting
      • Kaiser Permanente Northwest
      • Contact: Site Public Contact; Phone Number: 503-335-2400; Email: information@kpchr.org
      • Principal Investigator: Abdul Hai Mansoor
    • Portland, Oregon, United States, 97213
      • Suspended
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Suspended
      • Providence Saint Vincent Medical Center
    • Redmond, Oregon, United States, 97756
      • Suspended
      • Saint Charles Health System-Redmond
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Recruiting
      • Lehigh Valley Hospital-Cedar Crest
      • Contact: Site Public Contact; Phone Number: 610-402-9543; Email: Morgan_M.Horton@lvhn.org
      • Principal Investigator: Tareq Al baghdadi
    • Bethlehem, Pennsylvania, United States, 18017
      • Recruiting
      • Lehigh Valley Hospital - Muhlenberg
      • Contact: Site Public Contact; Phone Number: 610-402-9543; Email: Morgan_M.Horton@lvhn.org
      • Principal Investigator: Tareq Al baghdadi
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Active, not recruiting
      • Bryn Mawr Hospital
    • Chadds Ford, Pennsylvania, United States, 19317
      • Suspended
      • Christiana Care Health System-Concord Health Center
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Suspended
      • Pocono Medical Center
    • Hazleton, Pennsylvania, United States, 18201
      • Suspended
      • Lehigh Valley Hospital-Hazleton
    • Hershey, Pennsylvania, United States, 17033-0850
      • Recruiting
      • Penn State Milton S Hershey Medical Center
      • Principal Investigator: Monali K. Vasekar
      • Contact: Site Public Contact; Phone Number: 717-531-3779; Email: CTO@hmc.psu.edu
    • Media, Pennsylvania, United States, 19063
      • Active, not recruiting
      • Riddle Memorial Hospital
    • Paoli, Pennsylvania, United States, 19301
      • Active, not recruiting
      • Paoli Memorial Hospital
    • Phoenixville, Pennsylvania, United States, 19460
      • Suspended
      • Phoenixville Hospital
    • Sayre, Pennsylvania, United States, 18840
      • Recruiting
      • Guthrie Medical Group PC-Robert Packer Hospital
      • Contact: Site Public Contact; Phone Number: 800-836-0388
      • Principal Investigator: Joyson Poulose
    • Wynnewood, Pennsylvania, United States, 19096
      • Active, not recruiting
      • Lankenau Medical Center
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Suspended
      • Prisma Health Cancer Institute - Spartanburg
    • Charleston, South Carolina, United States, 29425
      • Active, not recruiting
      • Medical University of South Carolina
    • Clinton, South Carolina, United States, 29325
      • Suspended
      • Prisma Health Cancer Institute - Laurens
    • Easley, South Carolina, United States, 29640
      • Suspended
      • Prisma Health Cancer Institute - Easley
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Cancer Institute - Faris
      • Contact: Site Public Contact; Phone Number: 864-241-6251
      • Principal Investigator: Ki Y. Chung
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Cancer Institute - Butternut
      • Contact: Site Public Contact; Phone Number: 864-241-6251
      • Principal Investigator: Ki Y. Chung
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health Cancer Institute - Eastside
      • Contact: Site Public Contact; Phone Number: 864-241-6251
      • Principal Investigator: Ki Y. Chung
    • Greenville, South Carolina, United States, 29605
      • Suspended
      • Prisma Health Greenville Memorial Hospital
    • Greenwood, South Carolina, United States, 29646
      • Suspended
      • Self Regional Healthcare
    • Greer, South Carolina, United States, 29650
      • Suspended
      • Prisma Health Cancer Institute - Greer
    • Seneca, South Carolina, United States, 29672
      • Suspended
      • Prisma Health Cancer Institute - Seneca
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Active, not recruiting
      • Sanford Cancer Center Oncology Clinic
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Active, not recruiting
      • Sanford USD Medical Center - Sioux Falls
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Suspended
      • Memorial Hospital
    • Collierville, Tennessee, United States, 38017
      • Suspended
      • Baptist Memorial Hospital and Cancer Center-Collierville
    • Hixson, Tennessee, United States, 37343
      • Suspended
      • Pulmonary Medicine Center of Chattanooga-Hixson
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Baptist Memorial Hospital and Cancer Center-Memphis
      • Principal Investigator: Sailendra Vasireddy
      • Contact: Site Public Contact; Phone Number: 901-226-1366; Email: BCCclintrials@bmhcc.org
    • Memphis, Tennessee, United States, 38120
      • Suspended
      • Baptist Memorial Hospital for Women
    • Ooltewah, Tennessee, United States, 37363
      • Suspended
      • Memorial GYN Plus
  • Texas
    • Bryan, Texas, United States, 77802
      • Suspended
      • Saint Joseph Regional Cancer Center
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern/Simmons Cancer Center-Dallas
      • Contact: Site Public Contact; Phone Number: 214-648-7097; Email: canceranswerline@UTSouthwestern.edu
      • Principal Investigator: Vlad G. Zaha
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Contact: Site Public Contact; Phone Number: 214-648-7097; Email: canceranswerline@UTSouthwestern.edu
      • Principal Investigator: Vlad G. Zaha
    • Lubbock, Texas, United States, 79415
      • Active, not recruiting
      • UMC Cancer Center / UMC Health System
    • Richardson, Texas, United States, 75080
      • Recruiting
      • UT Southwestern Clinical Center at Richardson/Plano
      • Contact: Site Public Contact; Phone Number: 972-669-7044; Email: Suzanne.cole@utsouthwestern.edu
      • Principal Investigator: Vlad G. Zaha
    • San Antonio, Texas, United States, 78229
      • Active, not recruiting
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78229
      • Active, not recruiting
      • University Hospital
  • Virginia
    • Fishersville, Virginia, United States, 22939
      • Recruiting
      • Augusta Health Center for Cancer and Blood Disorders
      • Contact: Site Public Contact; Phone Number: 540-332-5960
      • Principal Investigator: Robert M. Kyler
  • Washington
    • Aberdeen, Washington, United States, 98520
      • Suspended
      • Providence Regional Cancer System-Aberdeen
    • Auburn, Washington, United States, 98001
      • Suspended
      • MultiCare Auburn Medical Center
    • Bainbridge Island, Washington, United States, 98110
      • Active, not recruiting
      • Virginia Mason Bainbridge Island Medical Center
    • Bellevue, Washington, United States, 98004
      • Suspended
      • Overlake Medical Center
    • Bellingham, Washington, United States, 98225
      • Recruiting
      • PeaceHealth Saint Joseph Medical Center
      • Contact: Site Public Contact; Phone Number: 360-788-8223
      • Principal Investigator: Charles W. Drescher
    • Bremerton, Washington, United States, 98310
      • Suspended
      • Harrison Medical Center
    • Bremerton, Washington, United States, 98310
      • Suspended
      • Harrison HealthPartners Hematology and Oncology-Bremerton
    • Burien, Washington, United States, 98166
      • Suspended
      • Highline Medical Center-Main Campus
    • Centralia, Washington, United States, 98531
      • Suspended
      • Providence Regional Cancer System-Centralia
    • Edmonds, Washington, United States, 98026
      • Suspended
      • Swedish Cancer Institute-Edmonds
    • Enumclaw, Washington, United States, 98022
      • Suspended
      • Saint Elizabeth Hospital
    • Everett, Washington, United States, 98201
      • Suspended
      • Providence Regional Cancer Partnership
    • Federal Way, Washington, United States, 98003
      • Suspended
      • Saint Francis Hospital
    • Federal Way, Washington, United States, 98002
      • Active, not recruiting
      • Virginia Mason Federal Way Medical Center
    • Gig Harbor, Washington, United States, 98335
      • Suspended
      • MultiCare Gig Harbor Medical Park
    • Gig Harbor, Washington, United States, 98332
      • Active, not recruiting
      • Tacoma/Valley Radiation Oncology Centers-Gig Harbor
    • Issaquah, Washington, United States, 98029
      • Recruiting
      • Swedish Cancer Institute-Issaquah
      • Contact: Site Public Contact; Phone Number: 206-215-3086; Email: PCRC-NCORP@Swedish.org
      • Principal Investigator: Charles W. Drescher
    • Kennewick, Washington, United States, 99336
      • Suspended
      • Kadlec Clinic Hematology and Oncology
    • Kennewick, Washington, United States, 99336
      • Active, not recruiting
      • Northwest Cancer Clinic
    • Lacey, Washington, United States, 98503
      • Suspended
      • Providence Regional Cancer System-Lacey
    • Lakewood, Washington, United States, 98499
      • Suspended
      • Saint Clare Hospital
    • Longview, Washington, United States, 98632
      • Suspended
      • PeaceHealth Saint John Medical Center
    • Lynnwood, Washington, United States, 98036
      • Active, not recruiting
      • Virginia Mason Lynnwood Medical Center
    • Port Townsend, Washington, United States, 98368
      • Suspended
      • Jefferson Healthcare
    • Poulsbo, Washington, United States, 98370
      • Active, not recruiting
      • Harrison HealthPartners Hematology and Oncology-Poulsbo
    • Poulsbo, Washington, United States, 98370
      • Active, not recruiting
      • Peninsula Cancer Center
    • Puyallup, Washington, United States, 98372
      • Active, not recruiting
      • MultiCare Good Samaritan Hospital
    • Puyallup, Washington, United States, 98372
      • Active, not recruiting
      • Tacoma/Valley Radiation Oncology Centers-Puyallup
    • Renton, Washington, United States, 98055
      • Suspended
      • Valley Medical Center
    • Seattle, Washington, United States, 98104
      • Suspended
      • Pacific Gynecology Specialists
    • Seattle, Washington, United States, 98107
      • Suspended
      • Swedish Medical Center-Ballard Campus
    • Seattle, Washington, United States, 98122-5711
      • Suspended
      • Swedish Medical Center-Cherry Hill
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Medical Center-First Hill
      • Contact: Site Public Contact; Phone Number: 206-215-3086; Email: PCRC-NCORP@Swedish.org
      • Principal Investigator: Charles W. Drescher
    • Seattle, Washington, United States, 98109
      • Recruiting
      • FHCC South Lake Union
      • Principal Investigator: Rachel L. Yung
      • Contact: Site Public Contact; Phone Number: 800-804-8824
    • Seattle, Washington, United States, 98112
      • Active, not recruiting
      • Kaiser Permanente Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center - Montlake
      • Principal Investigator: Rachel L. Yung
      • Contact: Site Public Contact; Phone Number: 800-804-8824
    • Seattle, Washington, United States, 98101
      • Active, not recruiting
      • Virginia Mason Medical Center
    • Sedro-Woolley, Washington, United States, 98284
      • Suspended
      • PeaceHealth United General Medical Center
    • Shelton, Washington, United States, 98584
      • Suspended
      • Providence Regional Cancer System-Shelton
    • Spokane, Washington, United States, 99204
      • Suspended
      • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
    • Spokane, Washington, United States, 99218
      • Suspended
      • MultiCare Deaconess Cancer and Blood Specialty Center - North
    • Spokane Valley, Washington, United States, 99216
      • Suspended
      • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
    • Tacoma, Washington, United States, 98405
      • Suspended
      • Franciscan Research Center-Northwest Medical Plaza
    • Tacoma, Washington, United States, 98405
      • Suspended
      • Northwest Medical Specialties PLLC
    • Tacoma, Washington, United States, 98405
      • Suspended
      • MultiCare Tacoma General Hospital
    • Tacoma, Washington, United States, 97405
      • Active, not recruiting
      • Tacoma/Valley Radiation Oncology Centers-Jackson Hall
    • Tacoma, Washington, United States, 98405
      • Active, not recruiting
      • Tacoma/Valley Radiation Oncology Centers-Saint Joe's
    • Vancouver, Washington, United States, 98664
      • Suspended
      • PeaceHealth Southwest Medical Center
    • Walla Walla, Washington, United States, 99362
      • Suspended
      • Providence Saint Mary Regional Cancer Center
    • Yakima, Washington, United States, 98902
      • Suspended
      • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Yelm, Washington, United States, 98597
      • Suspended
      • Providence Regional Cancer System-Yelm
  • West Virginia
    • Martinsburg, West Virginia, United States, 25401
      • Recruiting
      • WVUH-Berkely Medical Center
      • Contact: Site Public Contact; Phone Number: 304-293-7374; Email: cancertrialsinfo@hsc.wvu.edu
      • Principal Investigator: Danish Safi
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Healthcare
      • Contact: Site Public Contact; Phone Number: 304-293-7374; Email: cancertrialsinfo@hsc.wvu.edu
      • Principal Investigator: Danish Safi
    • Parkersburg, West Virginia, United States, 26101
      • Recruiting
      • Camden Clark Medical Center
      • Contact: Site Public Contact; Phone Number: 304-293-7374; Email: cancertrialsinfo@hsc.wvu.edu
      • Principal Investigator: Danish Safi
    • Wheeling, West Virginia, United States, 26003
      • Recruiting
      • Wheeling Hospital/Schiffler Cancer Center
      • Contact: Site Public Contact; Phone Number: 304-243-6442
      • Principal Investigator: Danish Safi
  • Wisconsin
    • Ashland, Wisconsin, United States, 54806
      • Active, not recruiting
      • Duluth Clinic Ashland
    • Green Bay, Wisconsin, United States, 54301
      • Suspended
      • Bellin Memorial Hospital
    • Janesville, Wisconsin, United States, 53548
      • Active, not recruiting
      • Mercyhealth Hospital and Cancer Center - Janesville
    • New Richmond, Wisconsin, United States, 54017
      • Suspended
      • Cancer Center of Western Wisconsin
  • Wyoming
    • Cody, Wyoming, United States, 82414
      • Suspended
      • Billings Clinic-Cody
    • Sheridan, Wyoming, United States, 82801
      • Suspended
      • Welch Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (carvedilol); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Carvedilol; Given PO; Other Names: Coreg
Active Comparator: Arm II (no intervention); Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks.	Other: Laboratory Biomarker Analysis; Correlative studies
Active Comparator: Arm III (observation); Patients undergo observation for up to 108 weeks.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Patient Observation; Undergo observation; Other Names: observation; Active Surveillance; deferred therapy; expectant management; Watchful Waiting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first identification of cardiac dysfunction	Real-time, blinded, central echocardiography (ECHO) read as a decrease in the left ventricular ejection fraction (LVEF) of >= 10 percentage points from baseline to a value of < 50% OR decrease of LVEF by >= 5 percentage points from baseline to LVEF < 50% in those baselines having a baseline LVEF of 50-54%. The distributions of time to cardiac dysfunction will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray's test will also be applied	Up to 108 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events associated with beta blocker treatment	Adverse events associated with beta blocker treatment will be assessed.	Up to 108 weeks
Rate of first interruption of trastuzumab	The distributions of time to interruption of trastuzumab-based therapy will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray?s test will also be applied to the primary endpoint to assess whether the results are sensitive to different model assumptions.	Up to 108 weeks
Rate of death	Will compare rate of death from competing causes between treatment arms via Cox regression to evaluate whether those rates impact the primary analysis comparison.	Up to 108 weeks
Time to first occurrence of cardiac event	any of the following treating physician documented events requiring hospitalization or medical treatment, and subsequent temporary or permanent discontinuation of trastuzumab- based HER-2 targeted therapy: arrhythmia, unstable angina, non-ST segment elevated myocardial infarction, myocardial infarction, or congestive heart failure.	Up to 108 weeks
Drug adherence	Patients on the active arm will be asked to record study drug consumption on a monthly intake calendar. Amount of study drug taken among patients randomized to the active arm and study drug adoption among patients randomized to the no intervention arm (i.e., contamination) will be recorded by study site staff on a case report form at each follow-up visit to assess the sensitivity of the primary treatment effect to observed conditions.	Up to 108 weeks

Collaborators and Investigators

• Sponsor: SWOG Cancer Research Network
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Justin Floyd, SWOG Cancer Research Network

Publications and helpful links

General Publications

• Sommers J, Dizon DS, Lewis MA, Stone E, Andreoli R, Henderson V. Assessing Health Information Seeking Behaviors Among Targeted Social Media Users Using an Infotainment Video About a Cancer Clinical Trial: Population-Based Descriptive Study. JMIR Cancer. 2025 Mar 3;11:e56098. doi: 10.2196/56098.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Heart Diseases; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Brain Neoplasms; Cardiotoxicity; Health Services Administration; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Methods; Quality of Health Care; Amines; Indoles; Alcohols; Propanolamines; Amino Alcohols; Propanols; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Heterocyclic Compounds, 3-Ring; Carbazoles; Carvedilol; Observation; Watchful Waiting
• Other Study ID Numbers: S1501 (Other Identifier: SWOG); UG1CA189974 (U.S. NIH Grant/Contract); NCI-2016-01047 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); SWOG-S1501 (Other Identifier: DCP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No