Recruiting
Phase 3

Carvedilol

Sponsor:

SWOG Cancer Research Network

Code:

NCT03418961

Conditions

Cardiotoxicity

HER2/Neu Positive

Metastatic Malignant Neoplasm in the Brain

Recurrent Breast Carcinoma

Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carvedilol

Laboratory Biomarker Analysis

Patient Observation

Study Details

Brief 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. 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.

Conditions

Cardiotoxicity

HER2/Neu Positive

Metastatic Malignant Neoplasm in the Brain

Recurrent Breast Carcinoma

Stage IV Breast Cancer AJCC v6 and v7

Study ID

NCT03418961

Start date

Nov 1, 2017

Status verified date

Oct, 2025

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 1 REGISTRATION

Patients must:

1. Have metastatic breast cancer, AND
2. Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND
3. Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration.

Examples of eligible HER-2 targeted therapy:

  • Trastuzumab or a trastuzumab biosimilar
  • Trastuzumab + chemotherapy or hormonal therapy
  • Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)
  • Ado-trastuzumab (Kadcyla®)
  • Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.

  • Patients must be at increased risk for cardiotoxicity defined by at least one of the following:

1. Previous anthracycline exposure OR
2. 1 or more of the following risk factors for heart disease:

  • LVEF 50-54% by local ECHO read\*
  • Age ≥ 65
  • BMI ≥ 30 kg/m2
  • Current or prior anti-hypertensive therapy
  • Diagnosis of coronary artery disease (CAD)
  • Diagnosis of diabetes mellitus
  • Diagnosis of atrial fibrillation/flutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.
  • Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in order to be randomized (Arms 1 and 2).

Patients enrolling in the observational cohort (Arm 3) must be currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration.

  • Patients must have a Zubrod Performance status of 0-2
  • Patients must have a complete physical examination and medical history within 28 days prior to registration
  • Patients must have LVEF >= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab.

If a 3D echocardiogram is performed at baseline, sites must ensure that standard 2D images, including 40chamber and 2-chamber views, are also obtained and submitted at subsequent timepoints.

All follow-up echocardiograms (every 12 weeks) must be performed using 2D imaging to allow for standardized assessments. Follow-up scans must be completed at a site that can provide 2D images per protocol requirements. The echocardiograms cannot be submitted for central read until after Step 1 registration is complete.

  • Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:

  • Serum bilirubin < 3.0 x institutional upper limit of normal (IULN)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) < 5.0 x IULN
  • Patients must not be dialysis dependent
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must be willing to submit blood specimens
  • Sites must seek additional patient consent for the future use of specimens
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations.
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • STEP 2 REGISTRATION (Randomization)
  • Patients must not be registered to step 2 until confirming via RAVE EDC that the patient's LVEF by echocardiogram was >= 50% by central review. Patients must be registered within 21 calendar days of submission of the ECHO study/
  • Site must verify that there is no known change in the step 1 eligibility since initial registration

Study Design

Enrollment

491 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (carvedilol)

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

active comparator: Arm II (no intervention)

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

active comparator: Arm III (observation)

Patients undergo observation for up to 108 weeks.

Interventions

Carvedilol

Given PO

Laboratory Biomarker Analysis

Correlative studies

Patient Observation

Undergo observation

Primary outcome measure

  • Time to the first identification of cardiac dysfunction [ Time Frame: Up to 108 weeks ]

Central Contacts and Locations

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Joanne E. Mortimer

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Priya Jayachandran

Contra Costa Regional Medical Center

Recruiting

Martinez, California, United States, 94553-3156

Contacts

Site Public Contact

925-957-5400

Principal Investigator:

Lisa Bailey

City of Hope Mission Hills

Recruiting

Mission Hills, California, United States, 91345

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Joanne E. Mortimer

City of Hope Newport Beach

Recruiting

Newport Beach, California, United States, 92660

Contacts

Site Public Contact

877-467-3411

Principal Investigator:

Joanne E. Mortimer

City of Hope South Pasadena

Recruiting

South Pasadena, California, United States, 91030

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Joanne E. Mortimer

City of Hope South Bay

Recruiting

Torrance, California, United States, 90503

Contacts

Site Public Contact

877-467-3411

Principal Investigator:

Joanne E. Mortimer

City of Hope Upland

Recruiting

Upland, California, United States, 91786

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Joanne E. Mortimer

Bayhealth Hospital Kent Campus

Recruiting

Dover, Delaware, United States, 19901

Contacts

Site Public Contact

302-744-6755mary_ella_quillen@bayhealth.org

Principal Investigator:

Iftekhar A. Khan

Beebe South Coastal Health Campus

Recruiting

Frankford, Delaware, United States, 19945

Contacts

Site Public Contact

302-291-6730research@beebehealthcare.org

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Site Public Contact

302-291-6730research@beebehealthcare.org

Principal Investigator:

Gregory A. Masters

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Public Contact

800-679-0775ClinicalTrials@moffitt.org

Principal Investigator:

Martine Extermann

Cleveland Clinic-Weston

Recruiting

Weston, Florida, United States, 33331

Contacts

Site Public Contact

954-659-5705CancerAnswer@ccf.org

Principal Investigator:

Halle C. Moore

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Kevin M. Kalinsky

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-303-3355ClinicalTrials@northside.com

Principal Investigator:

Amelia B. Zelnak

Northeast Georgia Medical Center-Gainesville

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Site Public Contact

770-219-8800cancerpatient.navigator@nghs.com

Principal Investigator:

Charles H. Nash

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Site Public Contact

912-819-5704underberga@sjchs.org

Principal Investigator:

Alison E. Spellman

Lewis Hall Singletary Oncology Center

Recruiting

Thomasville, Georgia, United States, 31792

Contacts

Site Public Contact

888-823-5923ctsucontact@westat.com

Principal Investigator:

Josh D. Simmons

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Site Public Contact

734-712-3671stephanie.couch@stjoeshealth.org

Principal Investigator:

John M. Schallenkamp

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

John H Stroger Jr Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-864-5204

Principal Investigator:

Thomas E. Lad

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Shelly S. Lo

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Franciscan Health Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Site Public Contact

317-528-7060

Principal Investigator:

Naveed A. Rana

Franciscan Saint Elizabeth Health - Lafayette East

Recruiting

Lafayette, Indiana, United States, 47905

Contacts

Site Public Contact

888-823-5923ctsucontact@westat.com

Principal Investigator:

Naveed A. Rana

Franciscan Health Mooresville

Recruiting

Mooresville, Indiana, United States, 46158

Contacts

Site Public Contact

317-834-3603

Principal Investigator:

Naveed A. Rana

Medical Oncology and Hematology Associates-West Des Moines

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

Mercy Cancer Center-West Lakes

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-358-6613cancerresearch@mercydesmoines.org

Principal Investigator:

Richard L. Deming

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-358-6613cancerresearch@mercydesmoines.org

Principal Investigator:

Richard L. Deming

Mission Cancer and Blood - Laurel

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

Mercy Medical Center-West Lakes

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-358-6613cancerresearch@mercydesmoines.org

Principal Investigator:

Richard L. Deming

HaysMed University of Kansas Health System

Recruiting

Hays, Kansas, United States, 67601

Contacts

Site Public Contact

785-623-5774

Principal Investigator:

Anne P. O'Dea

University of Kansas Cancer Center-West

Recruiting

Kansas City, Kansas, United States, 66112

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

Olathe Health Cancer Center

Recruiting

Olathe, Kansas, United States, 66061

Contacts

Site Public Contact

913-355-8000Jeni.wakefield@olathehealth.org

Principal Investigator:

Anne P. O'Dea

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000

Principal Investigator:

Anne P. O'Dea

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

Saint Joseph Hospital East

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Site Public Contact

859-629-7169ResearchInstituteInquiries@CommonSpirit.org

Principal Investigator:

Shahzad Siddique

LSU Health Baton Rouge-North Clinic

Recruiting

Baton Rouge, Louisiana, United States, 70805

Contacts

Site Public Contact

225-765-7659research@ololrmc.com

Principal Investigator:

Marshall P. Stagg

Louisiana Hematology Oncology Associates LLC

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Victor T. Lin

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Victor T. Lin

Our Lady of the Lake Physicians Group - Medical Oncology

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Site Public Contact

225-765-7659research@ololrmc.com

Principal Investigator:

Marshall P. Stagg

Louisiana Hematology Oncology Associates

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Victor T. Lin

Our Lady of the Lake Medical Oncology

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Site Public Contact

225-765-7659research@ololrmc.com

Principal Investigator:

Marshall P. Stagg

Woman's Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Site Public Contact

225-215-1353Clinicalreserach@marybird.com

Principal Investigator:

Victor T. Lin

UM Upper Chesapeake Medical Center

Recruiting

Bel Air, Maryland, United States, 21014

Contacts

Site Public Contact

443-643-3010

Principal Investigator:

Ashkan Bahrani

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Site Public Contact

781-744-3421lhmc-cancer-clinical-trials@lahey.org

Principal Investigator:

Andrew Piper-Vallillo

Winchester Hospital

Recruiting

Winchester, Massachusetts, United States, 01890

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Andrew Piper-Vallillo

Saint Joseph Mercy Hospital

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al Baghdadi

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Erin F. Cobain

McLaren Cancer Institute-Bay City

Recruiting

Bay City, Michigan, United States, 48706

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

Henry Ford Cancer Institute-Downriver

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

McLaren Cancer Institute-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Henry Ford Medical Center-Fairlane

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

McLaren Cancer Institute-Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

Singh and Arora Hematology Oncology PC

Recruiting

Flint, Michigan, United States, 48532

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

Spectrum Health at Butterworth Campus

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen J. Yost

Karmanos Cancer Institute at McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

McLaren Cancer Institute-Lapeer Region

Recruiting

Lapeer, Michigan, United States, 48446

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

McLaren Cancer Institute-Macomb

Recruiting

Mount Clemens, Michigan, United States, 48043

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Hadeel Assad

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Ascension Providence Hospitals - Southfield

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Site Public Contact

248-849-5332karen.fife@ascension.org

Principal Investigator:

Cynthia M. Vakhariya

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al Baghdadi

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Recruiting

Columbus, Mississippi, United States, 39705

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Sailendra Vasireddy

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

Barbara S. Craft

Saint Louis Cancer and Breast Institute-Ballwin

Recruiting

Ballwin, Missouri, United States, 63011

Contacts

Site Public Contact

314-251-7058

Principal Investigator:

Jay W. Carlson

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Capital Region Southwest Campus

Recruiting

Jefferson City, Missouri, United States, 65109

Contacts

Site Public Contact

573-632-4814swooden@mail.crmc.org

Principal Investigator:

Bryan A. Faller

Truman Medical Centers

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-404-4375

Principal Investigator:

Anne P. O'Dea

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

University of Kansas Cancer Center at North Kansas City Hospital

Recruiting

North Kansas City, Missouri, United States, 64116

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Anne P. O'Dea

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

CoxHealth South Hospital

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Saint Louis Cancer and Breast Institute-South City

Recruiting

St Louis, Missouri, United States, 63109

Contacts

Site Public Contact

314-353-1870

Principal Investigator:

Jay W. Carlson

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

janet.lesko@mercy.net

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Benefis Healthcare- Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Site Public Contact

973-971-5900

Principal Investigator:

Bonni L. Guerin

Overlook Hospital

Recruiting

Summit, New Jersey, United States, 07902

Contacts

Site Public Contact

908-522-2043

Principal Investigator:

Bonni L. Guerin

Holy Name Hospital

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Site Public Contact

201-833-6312

Principal Investigator:

Yadyra Rivera

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87102

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Jacklyn M. Nemunaitis

Nyack Hospital

Recruiting

Nyack, New York, United States, 10960

Contacts

Site Public Contact

845-348-8507

Principal Investigator:

Sung Ho B. Lee

Dickstein Cancer Treatment Center

Recruiting

White Plains, New York, United States, 10601

Contacts

Site Public Contact

914-849-7582mcortese@wphospital.org

Principal Investigator:

Dan Costin

Cleveland Clinic Akron General

Recruiting

Akron, Ohio, United States, 44307

Contacts

Site Public Contact

866-223-8100CancerAnswer@ccf.org

Principal Investigator:

Kathryn M. Leininger

UHHS-Chagrin Highlands Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Bahar Moftakhar

Aultman Health Foundation

Recruiting

Canton, Ohio, United States, 44710

Contacts

Site Public Contact

330-363-7274ClinicalReserachDept@aultman.com

Principal Investigator:

Sunitha Vemulapalli

Geauga Hospital

Recruiting

Chardon, Ohio, United States, 44024

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Bahar Moftakhar

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Site Public Contact

513-585-0844

Principal Investigator:

Gina G. Chung

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Mahmoud Charif

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Bahar Moftakhar

Cleveland Clinic Cancer Center/Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

Cleveland Clinic Cancer Center Independence

Recruiting

Independence, Ohio, United States, 44131

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

Cleveland Clinic Cancer Center Mansfield

Recruiting

Mansfield, Ohio, United States, 44906

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

Hillcrest Hospital Cancer Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

North Coast Cancer Care

Recruiting

Sandusky, Ohio, United States, 44870

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

Cleveland Clinic Cancer Center Strongsville

Recruiting

Strongsville, Ohio, United States, 44136

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

University Hospitals Sharon Health Center

Recruiting

Wadsworth, Ohio, United States, 44281

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Bahar Moftakhar

South Pointe Hospital

Recruiting

Warrensville Heights, Ohio, United States, 44122

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Mahmoud Charif

UH Seidman Cancer Center at Saint John Medical Center

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Bahar Moftakhar

UHHS-Westlake Medical Center

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Bahar Moftakhar

Cleveland Clinic Wooster Family Health and Surgery Center

Recruiting

Wooster, Ohio, United States, 44691

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Halle C. Moore

Kaiser Permanente Northwest

Recruiting

Portland, Oregon, United States, 97227

Contacts

Site Public Contact

503-335-2400information@kpchr.org

Principal Investigator:

Abdul Hai Mansoor

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Alexandra d. Zimmer

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Tareq Al Baghdadi

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Tareq Al Baghdadi

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Monali K. Vasekar

Guthrie Medical Group PC-Robert Packer Hospital

Recruiting

Sayre, Pennsylvania, United States, 18840

Contacts

Site Public Contact

800-836-0388

Principal Investigator:

Joyson Poulose

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-241-6251

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-241-6251

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Site Public Contact

864-241-6251

Principal Investigator:

Ki Y. Chung

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Sailendra Vasireddy

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Vlad G. Zaha

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Vlad G. Zaha

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Public Contact

972-669-7044Suzanne.cole@utsouthwestern.edu

Principal Investigator:

Vlad G. Zaha

Augusta Health Center for Cancer and Blood Disorders

Recruiting

Fishersville, Virginia, United States, 22939

Contacts

Site Public Contact

540-332-5960

Principal Investigator:

Robert M. Kyler

PeaceHealth Saint Joseph Medical Center

Recruiting

Bellingham, Washington, United States, 98225

Contacts

Site Public Contact

360-788-8223

Principal Investigator:

Charles W. Drescher

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Site Public Contact

206-215-3086PCRC-NCORP@Swedish.org

Principal Investigator:

Charles W. Drescher

FHCC South Lake Union

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Rachel L. Yung

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Site Public Contact

206-215-3086PCRC-NCORP@Swedish.org

Principal Investigator:

Charles W. Drescher

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Rachel L. Yung

WVUH-Berkely Medical Center

Recruiting

Martinsburg, West Virginia, United States, 25401

Contacts

Site Public Contact

304-293-7374cancertrialsinfo@hsc.wvu.edu

Principal Investigator:

Danish Safi

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Site Public Contact

304-293-7374cancertrialsinfo@hsc.wvu.edu

Principal Investigator:

Danish Safi

Camden Clark Medical Center

Recruiting

Parkersburg, West Virginia, United States, 26101

Contacts

Site Public Contact

304-293-7374cancertrialsinfo@hsc.wvu.edu

Principal Investigator:

Danish Safi

Wheeling Hospital/Schiffler Cancer Center

Recruiting

Wheeling, West Virginia, United States, 26003

Contacts

Site Public Contact

304-243-6442

Principal Investigator:

Danish Safi

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2025-10-08.