Anatomic Stage IV Breast Cancer AJCC v8NCT03723928
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
A study testing Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment and Anxiety Questionnaire Administration in people with Anatomic Stage IV Breast Cancer AJCC v8 and Estrogen Receptor Positive, run by SWOG Cancer Research Network at 723 sites in 3 countries.
Trial summary
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative
- What is being tested?
- Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment and Anxiety Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 723 sitesin 3 countries
- Study dates
- 17 Sep 2018to 1 Dec 2036
- Phase
- Interventional
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 a diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +/- targeted therapy +/- chemotherapy).
- NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic
- Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease
- Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease:
- CEA (must be tested)
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- CA 15-3 or CA 27.29 (at least one of these must be tested)
- At least one of the tested STMs must have been >= 1.5 x the institutional upper limit of normal at this time.
- Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.
- Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician.
- Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion
- Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility.
- Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels
- Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response
- Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule
- Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments
- Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging
- Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions:
- Adequately treated basal (or squamous cell) skin cancer
- Any cancer from which the patient has been disease free for five years
- Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins
- Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy.
- Patients must have decision making capacity and be able to provide informed consent
- 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; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation.
- As a part of the Oncology Patient Enrollment Network (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 RANDOMIZATION
- Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease:
- CEA (must be tested)
- CA 15-3 or CA 27.29 (whichever was tested prior to Step 1)
- Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.
- At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by >= 10% at this time.
- Patients must not have known progression since registration to step 1
- Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization
- Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)
Who cannot join
None listed.
Trial locations and contacts
723 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
314 sites in 3 countries
United States300 sites, 252 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jeffrey L. Berenberg
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jeffrey L. Berenberg
- Recruiting
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-487-7447
Jeffrey L. Berenberg
- Recruiting
Straub Pearlridge Clinic
‘Aiea, Hawaii, 96701
Site Public Contact, 808-522-4333
Jeffrey L. Berenberg
- Recruiting
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
Site Public Contact, 808-678-9000
Jeffrey L. Berenberg
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Jeffrey L. Berenberg
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Hickman Cancer Center
Adrian, Michigan, 49221
Site Public Contact, 517-265-0116
Rex B. Mowat
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Ursa A. Brown-Glaberman
- Recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Site Public Contact, 505-559-6113, WBurman@phs.org
Ursa A. Brown-Glaberman
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Saint Anthony's Health
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Suspended
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Lara N. Durna
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 805-219-4673, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-489-9164
Jade Jones
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Jade Jones
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Jade Jones
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Jade Jones
- Suspended
MultiCare Auburn Medical Center
Auburn, Washington, 98001
- Recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Suspended
The Medical Center of Aurora
Aurora, Colorado, 80012
- Recruiting
Rush - Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Pratima Chalasani
- Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 305-674-2625, yenrique@msmc.com
Michael A. Schwartz
- Recruiting
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Lara N. Durna
- Recruiting
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Site Public Contact, 314-251-7058
Jay W. Carlson
- Recruiting
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Kaiser Permanente Bellevue Medical Center
Bellevue, Washington, 98004
Site Public Contact, protocols@swog.org
Eric Y. Chen
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Lara N. Durna
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Charles W. Drescher
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 800-523-3977, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Preston D. Steen
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Suspended
Saint Vincent Healthcare
Billings, Montana, 59101
- Suspended
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Preston D. Steen
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Site Public Contact, 912-819-5704, underberga@sjchs.org
John A. Pablo
- Recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
- Recruiting
McFarland Clinic - Boone
Boone, Iowa, 50036
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Boulder Community Hospital
Boulder, Colorado, 80301
Site Public Contact, 303-777-2663, jbloomfield@co-cancerresearch.org
Nicholas DiBella
- Recruiting
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310
Site Public Contact, 308-398-6518, clinicaltrials@sfmc-gi.org
Richard L. Deming
- Recruiting
Harrison Medical Center
Bremerton, Washington, 98310
Site Public Contact, 253-426-6882, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Charles W. Drescher
- 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
Corrine L. Zarwan
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
Site Public Contact, 708-216-9000
Shelly S. Lo
- Suspended
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshall Cancer Center
Cameron Park, California, 95682
Site Public Contact, 530-672-7050, cancerservices@marshallmedical.org
Richard J. Bold
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-651-5550
Bryan A. Faller
- Active, not recruiting
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Mercy Cancer Center �� Carmichael
Carmichael, California, 95608
Site Public Contact, protocols@swog.org
Shahzad Siddique
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Caro Cancer Center
Caro, Michigan, 48723
Site Public Contact, 989-907-8411, lori.srebinski@ascension.org
Christopher M. Reynolds
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
- Recruiting
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Suspended
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Saint Mary's Hospital
Centralia, Illinois, 62801
Site Public Contact, protocols@swog.org
Jay W. Carlson
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Suspended
Memorial Hospital
Chattanooga, Tennessee, 37404
- Recruiting
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
Site Public Contact, CancerCare@ChesapeakeRegional.com
Charles H. Shelton
- Recruiting
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Site Public Contact, 314-205-6936
Joseph Sokhn
- Recruiting
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org
Nicholas DiBella
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Demet Gokalp Yasar
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 513-853-1300, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Brian R. Murphy
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325
Site Public Contact, 864-241-6251
Ki Y. Chung
- 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
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Drew S. Dill
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
Site Public Contact, 573-882-7440
Christos Papageorgiou
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Drew S. Dill
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Site Public Contact, 614-566-4475, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-566-4475, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Site Public Contact, 614-488-2118, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Mount Carmel Health Center West
Columbus, Ohio, 43222
Site Public Contact, 614-234-5433, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Doctors Hospital
Columbus, Ohio, 43228
Site Public Contact, 614-566-3275, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Site Public Contact, 603-224-2556
Douglas J. Weckstein
- Recruiting
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Site Public Contact, 931-783-2714
Thomas J. Summers
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
Site Public Contact, 877-547-1750, CancerClinicalTrials@bassett.org
Eric Bravin
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Charles W. Drescher
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Site Public Contact, 402-717-1510, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Pratima Chalasani
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Suspended
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Recruiting
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Suspended
Miami Valley Hospital North
Dayton, Ohio, 45415
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Active, not recruiting
Broward Health North
Deerfield Beach, Florida, 33064
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 740-615-0227, sheree@columbusccop.org
Timothy D. Moore
- Suspended
Delaware Radiation Oncology
Delaware, Ohio, 43015
- Recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
Site Public Contact, 740-615-2403, sheree@columbusccop.org
Timothy D. Moore
- Suspended
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
- Suspended
Denver Health Medical Center
Denver, Colorado, 80204
- Recruiting
National Jewish Health-Main Campus
Denver, Colorado, 80206
Site Public Contact, 877-225-5654, glicht@co-cancerresearch.org
Robert S. Kantor
- Recruiting
The Women's Imaging Center
Denver, Colorado, 80209
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Porter Adventist Hospital
Denver, Colorado, 80210
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Suspended
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218
- Recruiting
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Suspended
Rose Medical Center
Denver, Colorado, 80220
- Suspended
Western Surgical Care
Denver, Colorado, 80220
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah S. Mougalian
- 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
- Recruiting
Ascension Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Christopher M. Reynolds
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Site Public Contact, 215-345-2378, lheacock@dh.org
Ana Maria Lopez
- Recruiting
Epic Care-Dublin
Dublin, California, 94568
Site Public Contact, 925-875-1677
Lisa Bailey
- Recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
Site Public Contact, 614-566-3275, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
Site Public Contact, 800-752-9119, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Southwest Oncology PC
Durango, Colorado, 81301
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-2066, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Great Lakes Cancer Management Specialists-Doctors Park
East China, Michigan, 48054
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Christopher M. Reynolds
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601
Site Public Contact, 410-822-1000, Christina.weisenborn@umm.edu
Adam J. Goldrich
- Recruiting
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Site Public Contact, 920-433-8889, ewd_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Demet Gokalp Yasar
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-3086, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Pratima Chalasani
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Active, not recruiting
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 08234
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905
Site Public Contact, 607-271-7000
Serge Dauphin
- Recruiting
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Site Public Contact, 510-835-9900
Lisa Bailey
- Recruiting
Epic Care Partners in Cancer Care
Emeryville, California, 94608
Site Public Contact, 510-629-6682
Lisa Bailey
- Recruiting
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Swedish Medical Center
Englewood, Colorado, 80113
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
Site Public Contact, ryan.weight@theskincancerinstitute.com
Nicholas DiBella
- Suspended
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Recruiting
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, ewd_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Charles W. Drescher
- Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
Site Public Contact, 907-458-3043, Veronica.Stevenson@foundationhealth.org
Nicholas DiBella
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah S. Mougalian
- Recruiting
Sanford South University Medical Center
Fargo, North Dakota, 58103
Site Public Contact, 701-234-6161
Preston D. Steen
- Recruiting
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
Site Public Contact, 605-312-3320
Preston D. Steen
- Recruiting
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Site Public Contact, 800-437-4010
Preston D. Steen
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Preston D. Steen
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Preston D. Steen
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Suspended
Saint Francis Hospital
Federal Way, Washington, 98003
- Recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Orion Cancer Care
Findlay, Ohio, 45840
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Kaiser Permanente-Fontana
Fontana, California, 92335
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Lara N. Durna
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, 954-267-7748
Christopher M. Reynolds
- Active, not recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Suspended
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Unity Hospital
Fridley, Minnesota, 55432
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Site Public Contact, 309-344-2831
Bryan A. Faller
- Suspended
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
- Recruiting
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054
Site Public Contact, 704-834-2810, tammy.cozad@caromonthealth.org
Luiz O. Pita De Oliveira
- Suspended
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah S. Mougalian
- Suspended
Mountain Blue Cancer Care Center
Golden, Colorado, 80401
- Recruiting
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401
Site Public Contact, 303-777-2663, glicht@co-cancerresearch.org
Robert S. Kantor
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Active, not recruiting
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
- Active, not recruiting
Altru Cancer Center
Grand Forks, North Dakota, 58201
- Suspended
CHI Health Saint Francis
Grand Island, Nebraska, 68803
- Suspended
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
- Recruiting
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
North Colorado Medical Center
Greeley, Colorado, 80631
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, ewd_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, ewd_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Wayne Hospital
Greenville, Ohio, 45331
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- 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
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah S. Mougalian
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Drew S. Dill
- Recruiting
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Christopher M. Reynolds
- Recruiting
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Christopher M. Reynolds
- Suspended
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236
- Recruiting
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
Site Public Contact, 877-779-7585, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Zangmeister Center Grove City
Grove City, Ohio, 43123
Site Public Contact, 614-488-2745, sheree@columbusccop.org
Timothy D. Moore
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah S. Mougalian
- Recruiting
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Augusto C. Ochoa
- Active, not recruiting
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17101
- Active, not recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Sarah S. Mougalian
- Active, not recruiting
Nebraska Cancer Specialists/Oncology Hematology West PC - Hastings
Hastings, Nebraska, 68901
- Recruiting
HaysMed University of Kansas Health System
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Gary C. Doolittle
- Recruiting
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 570-459-2901, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Suspended
Saint Peter's Community Hospital
Helena, Montana, 59601
- Recruiting
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
- Recruiting
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
GenesisCare USA - Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
Site Public Contact, 912-819-5704, underberga@sjchs.org
John A. Pablo
- Suspended
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, 37343
- Recruiting
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491
Site Public Contact, 708-216-9000
Shelly S. Lo
- Recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Site Public Contact, 808-524-6115, i.webster@hawaiicancercare.com
Jeffrey L. Berenberg
- Suspended
Island Urology
Honolulu, Hawaii, 96813
- Recruiting
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Site Public Contact, 808-532-0315
Jeffrey L. Berenberg
- Recruiting
Queen's Medical Center
Honolulu, Hawaii, 96813
Site Public Contact, 808-545-8548
Jeffrey L. Berenberg
- Recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
Site Public Contact, 808-522-4333
Jeffrey L. Berenberg
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Site Public Contact, 808-586-2979
Jeffrey L. Berenberg
- Suspended
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
Puerto Rico13 sites, 6 recruiting
- Suspended
Advance Oncology Center
Aguadilla, 00603
- Suspended
Doctor's Cancer Center-Arecibo
Arecibo, 00614
- Recruiting
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060
Site Public Contact, 787-395-7085
Luis J. Santos Reyes
- Suspended
Hematologia Oncologia San Pablo
Bayamón, 00961
- Suspended
HIMA San Pablo Oncologic Hospital
Caguas, 00726
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
Luis J. Santos Reyes
- Suspended
Instituto Oncologia Moderna Ponce
Ponce, 00716
- Recruiting
San Juan Community Oncology Group
San Juan, 00917
Site Public Contact, 787-274-3387
Luis J. Santos Reyes
- Suspended
Primary Care Physician Group
San Juan, 00920
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Luis J. Santos Reyes
- Recruiting
PROncology
San Juan, 00927
Site Public Contact, 787-919-7919, info@PRoncology.com
Luis J. Santos Reyes
- Recruiting
San Juan City Hospital
San Juan, 00936
Site Public Contact, 787-763-1296
Luis J. Santos Reyes
- Suspended
Centro de Hematologia y Oncologia del Sur
Santa Isabel, 00757
About this study
Official title: Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.
SECONDARY OBJECTIVES:
- To compare cumulative direct healthcare costs through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population.
II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population.
TERTIARY OBJECTIVES:
- To assess modality and frequency of disease monitoring testing in the usual care cohort.
II. To assess the association of PROs and patient preferences for disease monitoring testing.
III. To evaluate predictors of physician preferences for disease monitoring testing.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.
ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive, Prognostic Stage IV Breast Cancer AJCC v8, Elevated CA15-3 or CEA or CA27-29
- Being tested
- Usual care disease monitoring, Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment, Anxiety Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care disease monitoringOther
Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).
Serum Tumor Marker directed disease monitoringOther
Also called STMDDM
Serum tumor markers every 4-8 weeks without imaging
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Anxiety Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | Active comparator | Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression. Receives: Other: Usual care disease monitoring; Other: Quality-of-Life Assessment; Other: Anxiety Questionnaire Administration |
| Arm II (serum tumor directed disease monitoring) | Experimental | Patients undergo disease specific serum tumor marker evaluation (CEA and either CA 15-3 or CA 27.29, whichever were tested at Step 1 Registration and Step 2 Registration) every 4-8 weeks (starting from randomization) without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression. Receives: Other: Serum Tumor Marker directed disease monitoring; Other: Quality-of-Life Assessment; Other: Anxiety Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care
The assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care will be based on multivariable Cox regression, adjusting for intervention assignment (intention-to-treat) and the stratification factor (bone only versus visceral disease). If at the time of final analysis the study shows notably fewer events than anticipated, extended follow-up will be examined for its potential to allow examination of the primary endpoint with full power.
Measured: Up to 312 weeks after randomization
Secondary outcomes (3)
Cumulative direct healthcare costs (in the United States) of patients monitored with STMDDM versus usual care
The comparison of direct healthcare costs (in the US) by arm will be based on a multivariable linear regression, adjusting for patient and tumor characteristics.
Measured: Up to 48 weeks after randomization
Assessment of anxiety of patients monitored with STMDDM compared to patients monitored with usual care
Patient anxiety will be measured at baseline and at 12, 24, 36, 48, and 102 after randomization using the State-Trait Anxiety inventory Scale (STAI-S). Differences in anxiety by arm will be evaluated using a mixed-effects model for repeated measures controlling for the baseline score and stratification factor as covariates. No direction of effect will be assumed, implying two-sided testing.
Measured: Up to 102 weeks after randomization
Assessment of quality of life of patients monitored with STMDDM versus patients monitored with usual care
Patient quality of life (QOL) will be measured at baseline and at weeks 12, 24, 36, 48, and 102 after randomization using the PROMIS-29. Differences in QOL by arm will be evaluated using a mixed-effects model for repeated measures, controlling for the baseline score and stratification factor as covariates. No direction of effect will be assumed, implying two-sided testing.
Measured: Up to 102 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start17 Sep 2018
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 739 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Melissa Accordino, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723928
- Sponsor's protocol ID
- S1703
- Other IDs
- NCI-2018-00090, S1703, SWOG-S1703, S1703, UG1CA189974
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2018
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No