CardiotoxicityPhase 3NCT03418961
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
A Phase 3 study testing Carvedilol, Laboratory Biomarker Analysis and Patient Observation in people with Cardiotoxicity and HER2/Neu Positive, run by SWOG Cancer Research Network at 590 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Carvedilol, Laboratory Biomarker Analysis and Patient Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 590 sitesin 4 countries
- Study dates
- 1 Nov 2017to 15 Sep 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEP 1 REGISTRATION
- Patients must:
- Have metastatic breast cancer, AND
- Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND
- 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:
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- 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:
- Previous anthracycline exposure OR
- 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
Who cannot join
None listed.
Trial locations and contacts
590 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
313 sites in 4 countries
United States300 sites, 74 recruiting
- Suspended
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
- Suspended
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
- Suspended
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Recruiting
Cleveland Clinic Akron General
Akron, Ohio, 44307
Site Public Contact, 866-223-8100, CancerAnswer@ccf.org
Kathryn M. Leininger
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Jacklyn M. Nemunaitis
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al Baghdadi
- Suspended
Community Hospital of Anaconda
Anaconda, Montana, 59711
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Suspended
Katmai Oncology Group
Anchorage, Alaska, 99508
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al Baghdadi
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Erin F. Cobain
- Active, not recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
- Active, not recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
- Suspended
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Kevin M. Kalinsky
- Suspended
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Amelia B. Zelnak
- Suspended
MultiCare Auburn Medical Center
Auburn, Washington, 98001
- Suspended
Rush - Copley Medical Center
Aurora, Illinois, 60504
- Active, not recruiting
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, 98110
- Suspended
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
- Recruiting
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Site Public Contact, 314-251-7058
Jay W. Carlson
- Suspended
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Victor T. Lin
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Victor T. Lin
- Active, not recruiting
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809
- Recruiting
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana, 70809
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Active, not recruiting
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
- Recruiting
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70817
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Victor T. Lin
- Recruiting
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, 70817
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Woman's Hospital
Baton Rouge, Louisiana, 70817
Site Public Contact, 225-215-1353, Clinicalreserach@marybird.com
Victor T. Lin
- Suspended
Bronson Battle Creek
Battle Creek, Michigan, 49017
- Recruiting
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Bahar Moftakhar
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Site Public Contact, 443-643-3010
Ashkan Bahrani
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Charles W. Drescher
- Active, not recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
- Suspended
Saint Charles Health System
Bend, Oregon, 97701
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al Baghdadi
- Suspended
Billings Clinic Cancer Center
Billings, Montana, 59101
- Active, not recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
- Suspended
McLaren Cancer Institute-Bloomfield
Bloomfield, Michigan, 48302
- Suspended
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
- Suspended
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Suspended
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
- Suspended
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
- Active, not recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
- Suspended
Cox Cancer Center Branson
Branson, Missouri, 65616
- Suspended
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310
- Suspended
Harrison Medical Center
Bremerton, Washington, 98310
- Suspended
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
- Suspended
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Active, not recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Suspended
Highline Medical Center-Main Campus
Burien, Washington, 98166
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org
Andrew Piper-Vallillo
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Suspended
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
- Suspended
Illinois CancerCare-Canton
Canton, Illinois, 61520
- Suspended
Saint Joseph Mercy Canton
Canton, Michigan, 48188
- Suspended
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Sunitha Vemulapalli
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Suspended
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
- Suspended
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Suspended
SIH Cancer Institute
Carterville, Illinois, 62918
- Suspended
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
- Active, not recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Active, not recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
- Suspended
Centralia Oncology Clinic
Centralia, Illinois, 62801
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Suspended
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
- Recruiting
Geauga Hospital
Chardon, Ohio, 44024
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Bahar Moftakhar
- Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Suspended
Memorial Hospital
Chattanooga, Tennessee, 37404
- Suspended
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
- Suspended
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Thomas E. Lad
- Active, not recruiting
University of Illinois
Chicago, Illinois, 60612
- Active, not recruiting
Enloe Medical Center
Chico, California, 95926
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Site Public Contact, 513-585-0844
Gina G. Chung
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Mahmoud Charif
- Suspended
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Suspended
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Suspended
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
- Suspended
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
- Active, not recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
- Suspended
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Suspended
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
- Recruiting
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Bahar Moftakhar
- Recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Halle C. Moore
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Halle C. Moore
- Active, not recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
- Suspended
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Suspended
Billings Clinic-Cody
Cody, Wyoming, 82414
- Suspended
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
- Suspended
Coffeyville Regional Medical Center
Coffeyville, Kansas, 67337
- Suspended
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
- Suspended
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Suspended
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
- Active, not recruiting
John B Amos Cancer Center
Columbus, Georgia, 31904
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Sailendra Vasireddy
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Suspended
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Active, not recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
- Suspended
Greater Regional Medical Center
Creston, Iowa, 50801
- Active, not recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Vlad G. Zaha
- Suspended
Carle at The Riverfront
Danville, Illinois, 61832
- Suspended
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
- Active, not recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
- Active, not recruiting
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
- Active, not recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Suspended
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Kaiser Permanente-Franklin
Denver, Colorado, 80205
- Suspended
Porter Adventist Hospital
Denver, Colorado, 80210
- Suspended
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218
- Active, not recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
- Active, not recruiting
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
- Active, not recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Active, not recruiting
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
- Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Suspended
Ascension Saint John Hospital
Detroit, Michigan, 48236
- Recruiting
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901
Site Public Contact, 302-744-6755, mary_ella_quillen@bayhealth.org
Iftekhar A. Khan
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Joanne E. Mortimer
- Suspended
Epic Care-Dublin
Dublin, California, 94568
- Active, not recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
- Active, not recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
- Active, not recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
- Suspended
Mercy Medical Center
Durango, Colorado, 81301
- Suspended
Southwest Oncology PC
Durango, Colorado, 81301
- Suspended
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
- Suspended
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, 48054
- Suspended
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
- Suspended
Fairview Southdale Hospital
Edina, Minnesota, 55435
- Suspended
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
- Suspended
Carle Physician Group-Effingham
Effingham, Illinois, 62401
- Suspended
Crossroads Cancer Center
Effingham, Illinois, 62401
- Suspended
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035
- Suspended
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
- Suspended
Epic Care Partners in Cancer Care
Emeryville, California, 94608
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Suspended
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Suspended
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
- Suspended
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Suspended
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
- Active, not recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
- Active, not recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
- Active, not recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
- Active, not recruiting
Virginia Mason Federal Way Medical Center
Federal Way, Washington, 98002
- Suspended
Saint Francis Hospital
Federal Way, Washington, 98003
- Active, not recruiting
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Active, not recruiting
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939
Site Public Contact, 540-332-5960
Robert M. Kyler
- Suspended
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Suspended
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
- Suspended
Hurley Medical Center
Flint, Michigan, 48503
- Recruiting
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Recruiting
Singh and Arora Hematology Oncology PC
Flint, Michigan, 48532
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Active, not recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Vlad G. Zaha
- Recruiting
Beebe South Coastal Health Campus
Frankford, Delaware, 19945
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Active, not recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Active, not recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
- Active, not recruiting
Fresno Cancer Center
Fresno, California, 93720
- Active, not recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
- Suspended
Unity Hospital
Fridley, Minnesota, 55432
- Suspended
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
- Recruiting
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Site Public Contact, 770-219-8800, cancerpatient.navigator@nghs.com
Charles H. Nash
- Suspended
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Suspended
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
- Suspended
Saint Catherine Hospital
Garden City, Kansas, 67846
- Active, not recruiting
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor, Washington, 98332
- Suspended
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335
- Suspended
Mountain Blue Cancer Care Center
Golden, Colorado, 80401
- Active, not recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
- Active, not recruiting
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
- Suspended
CHI Health Saint Francis
Grand Island, Nebraska, 68803
- Recruiting
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Suspended
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
- Recruiting
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Great Falls Clinic
Great Falls, Montana, 59405
- Suspended
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301
- Active, not recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Active, not recruiting
Wayne Hospital
Greenville, Ohio, 45331
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Ki Y. Chung
- Suspended
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-241-6251
Ki Y. Chung
- Suspended
Self Regional Healthcare
Greenwood, South Carolina, 29646
- Suspended
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
- Suspended
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
- Suspended
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236
- Suspended
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
- Suspended
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236
- Recruiting
HaysMed University of Kansas Health System
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Anne P. O'Dea
- Suspended
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
- Suspended
Saint Peter's Community Hospital
Helena, Montana, 59601
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Monali K. Vasekar
- Active, not recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
- Suspended
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, 37343
- Suspended
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
- Suspended
Island Urology
Honolulu, Hawaii, 96813
- Suspended
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
- Suspended
Queen's Medical Center
Honolulu, Hawaii, 96813
- Suspended
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
- Suspended
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
- Suspended
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
- Suspended
Kuakini Medical Center
Honolulu, Hawaii, 96817
- Suspended
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
- Suspended
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
- Active, not recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
- Suspended
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
- Suspended
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
- Active, not recruiting
Centerpoint Medical Center LLC
Independence, Missouri, 64057
- Recruiting
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Halle C. Moore
- Recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Site Public Contact, 317-528-7060
Naveed A. Rana
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Suspended
Allegiance Health
Jackson, Michigan, 49201
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
Barbara S. Craft
- Active, not recruiting
Onslow Memorial Hospital
Jacksonville, North Carolina, 28546
- Active, not recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
- Active, not recruiting
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548
- Recruiting
Capital Region Southwest Campus
Jefferson City, Missouri, 65109
Site Public Contact, 573-632-4814, swooden@mail.crmc.org
Bryan A. Faller
- Suspended
Freeman Health System
Joplin, Missouri, 64804
- Suspended
Mercy Hospital Joplin
Joplin, Missouri, 64804
- Suspended
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
- Suspended
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
- Suspended
Borgess Medical Center
Kalamazoo, Michigan, 49048
- Suspended
Kalispell Regional Medical Center
Kalispell, Montana, 59901
- Recruiting
University of Kansas Cancer Center-West
Kansas City, Kansas, 66112
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Anne P. O'Dea
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Anne P. O'Dea
- Recruiting
Truman Medical Centers
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Anne P. O'Dea
- Active, not recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
- Active, not recruiting
Research Medical Center
Kansas City, Missouri, 64132
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Anne P. O'Dea
- Suspended
Heartland Hematology and Oncology
Kearney, Nebraska, 68845
- Suspended
CHI Health Good Samaritan
Kearney, Nebraska, 68847
- Suspended
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
- Active, not recruiting
Northwest Cancer Clinic
Kennewick, Washington, 99336
- Active, not recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Active, not recruiting
First Dayton Cancer Care
Kettering, Ohio, 45420
- Active, not recruiting
Kettering Medical Center
Kettering, Ohio, 45429
- Suspended
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
- Suspended
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
- Suspended
Good Samaritan Medical Center
Lafayette, Colorado, 80026
- Suspended
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
- Recruiting
Franciscan Saint Elizabeth Health - Lafayette East
Lafayette, Indiana, 47905
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Naveed A. Rana
- Suspended
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
- Suspended
Saint Anthony Hospital
Lakewood, Colorado, 80228
- Suspended
Saint Clare Hospital
Lakewood, Washington, 98499
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Suspended
Sparrow Hospital
Lansing, Michigan, 48912
- Recruiting
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Hadeel Assad
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Anne P. O'Dea
- Active, not recruiting
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086
- Active, not recruiting
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, 66219
- Active, not recruiting
Minimally Invasive Surgery Hospital
Lenexa, Kansas, 66219
- Suspended
Beebe Medical Center
Lewes, Delaware, 19958
- Suspended
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
- Recruiting
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Suspended
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
- Suspended
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
- Suspended
Littleton Adventist Hospital
Littleton, Colorado, 80122
- Suspended
Hope Cancer Clinic
Livonia, Michigan, 48154
Puerto Rico11 sites
- Active, not recruiting
Advance Oncology Center
Aguadilla, 00603
- Active, not recruiting
Doctor's Cancer Center-Arecibo
Arecibo, 00614
- Active, not recruiting
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060
- Active, not recruiting
Hematologia Oncologia San Pablo
Bayamón, 00961
- Active, not recruiting
HIMA San Pablo Oncologic Hospital
Caguas, 00726
- Active, not recruiting
Doctors Cancer Center
Manati, 00674
- Active, not recruiting
Instituto Oncologia Moderna Ponce
Ponce, 00716
- Active, not recruiting
San Juan Community Oncology Group
San Juan, 00917
- Active, not recruiting
Primary Care Physician Group
San Juan, 00920
- Active, not recruiting
San Juan City Hospital
San Juan, 00936
- Active, not recruiting
Centro de Hematologia y Oncologia del Sur
Santa Isabel, 00757
Saudi Arabia1 site
- Active, not recruiting
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, 410-769
Site Public Contact, 82-31-920-1934
Keun Seok Lee
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
- Being tested
- Carvedilol, Laboratory Biomarker Analysis, Patient Observation
- Medical subject headings
- Cardiotoxicity, Brain Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Coreg
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Patient ObservationOther
Also called Active Surveillance, deferred therapy, expectant management, observation
Undergo observation
| Study group | Role | What they receive |
|---|---|---|
| Arm I (carvedilol) | Experimental | 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. Receives: Drug: Carvedilol; Other: Laboratory Biomarker Analysis |
| Arm II (no intervention) | Active comparator | Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks. Receives: Other: Laboratory Biomarker Analysis |
| Arm III (observation) | Active comparator | Patients undergo observation for up to 108 weeks. Receives: Other: Laboratory Biomarker Analysis; Other: Patient Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 108 weeks
Secondary outcomes (5)
Incidence of adverse events associated with beta blocker treatment
Adverse events associated with beta blocker treatment will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Nov 2017
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 491 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Justin Floyd, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418961
- Sponsor's protocol ID
- S1501
- Other IDs
- UG1CA189974, NCI-2016-01047, S1501, SWOG-S1501
- Status last verified
- Oct 2025
- First submitted
- 2 Jan 2018
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 40029972