AzTrials
AzTrials

Stage I Breast CancerPhase 3DEBRANCT04852887

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

A Phase 3 study testing Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) in people with Stage I Breast Cancer, run by NRG Oncology at 832 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Stage I Breast Cancer
What is being tested?
Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,670 participants
Where
832 sitesin 4 countries
Study dates
23 Jun 2021to Jul 2041
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information.
  • The patient must have an ECOG performance status of 0 or 1.
  • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.)
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
  • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
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  • By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm).
  • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
  • Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.
  • For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry/Step 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis.
  • The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection.
  • An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary "Low" category will meet this eligibility criteria and an Oncotype RS does not need to be performed.
  • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive.
  • The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
  • Patients may be premenopausal or postmenopausal at the time of pre-entry/Step 1. For study purposes, postmenopausal is defined as:
  • Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or
  • Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy.
  • The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days.
  • The patient must have recovered from surgery with the incision completely healed and no signs of infection.
  • Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.

Who cannot join

  • • Definitive clinical or radiologic evidence of metastatic disease.
  • pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
  • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
  • Patient had a mastectomy.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
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  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
  • Paget's disease of the nipple.
  • Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  • Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
  • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)
  • Treatment plan that includes regional nodal irradiation.
  • Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1.
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1.
  • Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention.
  • Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if:
  • the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND
  • the patient had not initiated endocrine therapy prior to core biopsy tissue collection.
  • This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1).
  • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
  • Prior breast or thoracic RT for any condition.
  • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.)
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
  • Use of any investigational product within 30 days prior to pre-entry/Step 1.

Trial locations and contacts

832 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Director Department of Regulatory Affairs contact

412-339-5300

langerj@nrgoncology.org

Norman Wolmark, MD contact

320 sites in 4 countries

United States300 sites, 254 recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-539-2273, info@hawaiicancercare.com

    Jami A. Fukui

    Recruiting

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-486-6000

    Jami A. Fukui

    Recruiting

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-487-7447

    Jami A. Fukui

    Recruiting

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

    Site Public Contact, 808-678-9000

    Jami A. Fukui

    Recruiting

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Jami A. Fukui

    Recruiting

  • Hendrick Medical Center

    Abilene, Texas, 79601

    Active, not recruiting

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

    Site Public Contact, 330-375-4221, cancerresearch@summahealth.org

    Desiree E. Doncals

    Recruiting

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

    Site Public Contact, 866-223-8100, CancerAnswer@ccf.org

    Ashok Ramalingam

    Recruiting

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

    Site Public Contact, 800-804-9376

    Hadley J. Sharp

    Recruiting

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

    Site Public Contact, 855-776-0015

    Dean A. Shumway

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    David Y. Lee

    Recruiting

  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

    Suspended

  • Northside Hospital-Alpharetta

    Alpharetta, Georgia, 30005

    Site Public Contact, 404-303-3355, clinical.trials@northside.com

    Amelia B. Zelnak

    Recruiting

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

    Site Public Contact, 407-303-2200

    Catherine S. Hwang

    Recruiting

  • Alton Memorial Hospital

    Alton, Illinois, 62002

    Active, not recruiting

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

    Site Public Contact, 801-855-4100, officeofresearch@imail.org

    Dustin Boothe

    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

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Aakash Batra

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Lori J. Pierce

    Recruiting

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Samantha A. Seaward

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Active, not recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Site Public Contact, 720-874-1881, 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

  • Mission Hospital

    Asheville, North Carolina, 28801

    Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com

    Andrew S. Kennedy

    Recruiting

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

    Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com

    Andrew S. Kennedy

    Recruiting

  • Mount Sinai Queens

    Astoria, New York, 11102

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Manjeet Chadha

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Jolinta Y. Lin

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Jolinta Y. Lin

    Recruiting

  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Site Public Contact, 404-425-7943, ORS@piedmont.org

    Adam W. Nowlan

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Jolinta Y. Lin

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Jolinta Y. Lin

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-303-3355, ClinicalTrials@northside.com

    Amelia B. Zelnak

    Recruiting

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Rachel A. Rabinovitch

    Recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Suspended

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Ellen L. Ziaja

    Recruiting

  • GenesisCare USA - Aventura FP

    Aventura, Florida, 33180

    Suspended

  • GenesisCare USA - Aventura

    Aventura, Florida, 33180

    Suspended

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 305-674-2625, yenrique@msmc.com

    Debra L. Linzer

    Recruiting

  • IU Health West Hospital

    Avon, Indiana, 46123

    Suspended

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

    Suspended

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Sarah A. Mcavoy

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Site Public Contact, 443-849-3706

    Kruti Patel

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Active, not recruiting

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

    Site Public Contact, 410-368-2910

    Richard S. Hudes

    Recruiting

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

    Site Public Contact, 443-777-7364

    Paul B. Fowler

    Recruiting

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

    Site Public Contact, 410-261-8151, Barbara.rector@medstar.net

    Paul B. Fowler

    Recruiting

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

    Site Public Contact, 330-375-4221, cancerresearch@summahealth.org

    Desiree E. Doncals

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Ellen L. Ziaja

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Lior Z. Braunstein

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Brianna M. Jones

    Recruiting

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Sandra FINK Templeton

    Recruiting

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Janice Lyons

    Recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Kamila Nowak Choi

    Recruiting

  • MedStar Health Bel Air Medical Campus

    Bel Air, Maryland, 21015

    Site Public Contact, David.j.perry2@medstar.net

    Paul B. Fowler

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Andrew O. Wahl

    Recruiting

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Aakash Batra

    Recruiting

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Site Public Contact, 360-788-8223, achapman1@peacehealth.org

    Dan S. Zuckerman

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

    Suspended

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Suspended

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Lourdes Hospital

    Binghamton, New York, 13905

    Site Public Contact, 607-798-5230

    Beka Aroshidze

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Active, not recruiting

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    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 L. Mikell

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Suspended

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

    Active, not recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Florida Cancer Specialists - Bradenton Cancer Center

    Bradenton, Florida, 34205

    Site Public Contact, 239-274-9930, clinicaltrials@flcancer.com

    Kunal Saigal

    Recruiting

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

    Site Public Contact, 800-987-3005

    Sarah J. Sinclair

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Lori J. Pierce

    Recruiting

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

    Site Public Contact, 646-754-4624, david.wallach@nyulangone.org

    Naamit K. Gerber

    Recruiting

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

    Suspended

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Simon D. Fung-Kee-Fung

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Puyao Li

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Puyao Li

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Ellen L. Ziaja

    Recruiting

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Suspended

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

    Site Public Contact, 315-472-7504

    Steven M. Duffy

    Recruiting

  • Sands Cancer Center

    Canandaigua, New York, 14424

    Site Public Contact, 585-396-6161

    Kimberly Gergelis

    Recruiting

  • Northside Hospital-Cherokee

    Canton, Georgia, 30115

    Site Public Contact, 404-303-3355, clinical.trials@northside.com

    Amelia B. Zelnak

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

    Site Public Contact, 888-293-4673

    Edward J. Walsh

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Jessica L. Wobb

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Site Public Contact, 618-457-5200, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Suspended

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org

    Matthew D. Wheatley

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • 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

    Recruiting

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

    Site Public Contact, 435-868-5680, officeofresearch@imail.org

    Dustin Boothe

    Recruiting

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

    Site Public Contact, 319-368-5514, Rachel.varner@unitypoint.org

    Candace R. Correa

    Recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Suspended

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    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

    Suspended

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Active, not recruiting

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Sherif F. Yacoub

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Harriet B. Eldredge-Hindy

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Hadley J. Sharp

    Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    William B. Warlick

    Recruiting

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

    Site Public Contact, 980-442-2000

    Hadley J. Sharp

    Recruiting

  • Levine Cancer Institute-SouthPark

    Charlotte, North Carolina, 28211

    Site Public Contact, 980-442-2000

    Hadley J. Sharp

    Recruiting

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

    Site Public Contact, 800-804-9376

    Hadley J. Sharp

    Recruiting

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

    Site Public Contact, 800-804-9376

    Hadley J. Sharp

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Eric D. Donnelly

    Recruiting

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

    Site Public Contact, 312-864-5204

    Deimante M. Tamkus

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Thomas Kim

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Steven J. Chmura

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Ellen L. Ziaja

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Teresa Meier

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Active, not recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

    Site Public Contact, 941-833-5700, rudi.ross@profoundresearch.io

    Frank A. Vicini

    Recruiting

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

    Site Public Contact, 888-716-9259

    Doris R. Brown

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Janice Lyons

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Site Public Contact, 216-778-7559, ababal@metrohealth.org

    Suzanne M. Russo

    Recruiting

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Saju A. Rajan

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Active, not recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Rachel A. Rabinovitch

    Recruiting

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

    Site Public Contact, 443-546-1300

    Sarah A. Mcavoy

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Gregory B. Biedermann

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Sasha J. Beyer

    Recruiting

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Sana Rehman

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Sana Rehman

    Recruiting

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Sana Rehman

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Lior Z. Braunstein

    Recruiting

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

    Active, not recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Hadley J. Sharp

    Recruiting

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Simona F. Shaitelman

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

    Site Public Contact, 877-547-1750, CancerClinicalTrials@bassett.org

    Timothy P. Korytko

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Cristiane Takita

    Recruiting

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

    Active, not recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Active, not recruiting

  • Northwest Cancer Center - Main Campus

    Crown Point, Indiana, 46307

    Site Public Contact, 219-310-2550

    Kalika P. Sarma

    Recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Steven J. Chmura

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Ellen L. Ziaja

    Recruiting

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

    Site Public Contact, 404-303-3355, clinicaltrials@northside.com

    Amelia B. Zelnak

    Recruiting

  • Houston Methodist Cypress Hospital

    Cypress, Texas, 77429

    Site Public Contact, 346-356-1413, irb@houstonmethodist.org

    Sandra FINK Templeton

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Kalika P. Sarma

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Heath B. Mackley

    Recruiting

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023-1291

    Site Public Contact, 610-237-4982

    Pramila R. Anne

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Jolinta Y. Lin

    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

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Cristiane Takita

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Eric D. Donnelly

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Sana Rehman

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Sana Rehman

    Recruiting

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Rachel A. Rabinovitch

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Suspended

  • Rose Medical Center

    Denver, Colorado, 80220

    Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org

    Andrew S. Kennedy

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Samir Narayan

    Recruiting

  • Dillon Health Center/Shaw Cancer Center

    Dillon, Colorado, 80435

    Site Public Contact, 970-470-7170

    Patricia H. Hardenbergh

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Cristiane Takita

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Ellen L. Ziaja

    Recruiting

  • Epic Care-Dublin

    Dublin, California, 94568

    Active, not recruiting

  • Kaiser Permanente Dublin

    Dublin, California, 94568

    Site Public Contact, 877-642-4691

    Samantha A. Seaward

    Recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Sana Rehman

    Recruiting

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

    Site Public Contact, 888-808-6762

    Pramila R. Anne

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Kalika P. Sarma

    Recruiting

  • The Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548

    Site Public Contact, 516-325-7514, Stephanie.Solito@chsli.org

    Rajasree Roy

    Recruiting

  • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

    East Norriton, Pennsylvania, 19401

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Rebecca M. Shulman

    Recruiting

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

    Site Public Contact, 315-472-7504

    Steven M. Duffy

    Recruiting

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

    Site Public Contact, 410-822-1000, Christina.weisenborn@umm.edu

    Sarah A. Mcavoy

    Recruiting

  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045

    Suspended

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

    Active, not recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Dan S. Zuckerman

    Recruiting

  • Shaw Cancer Center

    Edwards, Colorado, 81632

    Site Public Contact, 970-569-7429

    Patricia H. Hardenbergh

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Kalika P. Sarma

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Ellen L. Ziaja

    Recruiting

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

    Site Public Contact, 630-758-5460, Jrohde@emhc.org

    Mansoina Baweja

    Recruiting

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

    Suspended

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

    Active, not recruiting

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

    Active, not recruiting

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

    Active, not recruiting

  • Swedish Medical Center

    Englewood, Colorado, 80113

    Suspended

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

    Active, not recruiting

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

    Site Public Contact, 717-721-4840

    Sherif F. Yacoub

    Recruiting

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

    Site Public Contact, 814-452-5000

    Mark G. Trombetta

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Active, not recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Active, not recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

    Site Public Contact, 941-833-5700, rudi.ross@profoundresearch.io

    Frank A. Vicini

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

    Site Public Contact, 248-551-7695

    Peter Y. Chen

    Recruiting

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam W. Nowlan

    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

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Samir Narayan

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Samir Narayan

    Recruiting

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Brian K. Yeh

    Recruiting

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

    Site Public Contact, 843-777-0770, dorie.sturgill@mcleodhealth.org

    Rajesh Bajaj

    Recruiting

  • Saint Agnes Hospital/Agnesian Cancer Center

    Fond du Lac, Wisconsin, 54935

    Suspended

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Ellen L. Ziaja

    Recruiting

  • Levine Cancer Institute - Rutherford

    Forest City, North Carolina, 28043

    Site Public Contact, 800-804-9376

    Hadley J. Sharp

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Rachel A. Rabinovitch

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Rachel A. Rabinovitch

    Recruiting

  • Regional Cancer Center-Lee Memorial Health System

    Fort Myers, Florida, 33905

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Leandro P. Moraes

    Recruiting

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

    Active, not recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Howard M. Gross

    Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Samantha A. Seaward

    Recruiting

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

    Site Public Contact, clinicalresearch@sutterhealth.org

    Kristie A. Bobolis

    Recruiting

  • Washington Hospital

    Fremont, California, 94538

    Site Public Contact, 510-745-6433

    Emi J. Yoshida

    Recruiting

  • Fresno Cancer Center

    Fresno, California, 93720

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Samantha A. Seaward

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Samantha A. Seaward

    Recruiting

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Samantha A. Seaward

    Recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Active, not recruiting

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

    Site Public Contact, 215-794-2700

    Rebecca M. Shulman

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010, cancer-center@ufl.edu

    Tithi Biswas

    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

    Suspended

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

    Site Public Contact, 409-772-1950, clinical.research@utmb.edu

    Mediha Ahmad

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Eric D. Donnelly

    Recruiting

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

    Site Public Contact, 843-545-5600, broe@tidelandshealth.org

    Harriet B. Eldredge-Hindy

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Ellen L. Ziaja

    Recruiting

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

    Site Public Contact, 877-441-7957

    Sherif F. Yacoub

    Recruiting

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

    Site Public Contact, 410-553-8100

    Sarah A. Mcavoy

    Recruiting

  • Crozer Regional Cancer Center at Brinton Lake

    Glen Mills, Pennsylvania, 19342

    Active, not recruiting

  • Glens Falls Hospital

    Glens Falls, New York, 12801

    Site Public Contact, 518-926-6700

    Puyao Li

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Eric D. Donnelly

    Recruiting

  • Lutheran Hospital - Cancer Centers of Colorado

    Golden, Colorado, 80401

    Site Public Contact, peaksresearch@imail.org

    Karng S. Log

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Ellen L. Ziaja

    Recruiting

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

    Site Public Contact, 701-780-6520

    Grant R. Seeger

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Eric D. Donnelly

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Rachel A. Rabinovitch

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_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, wi_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Ellen L. Ziaja

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Brianna M. Jones

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Frank A. Vicini

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

    Site Public Contact, 503-413-2150

    Andrew Y. Kee

    Recruiting

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39502

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Augusto C. Ochoa

    Recruiting

  • Smilow Cancer Hospital-Hamden Care Center

    Hamden, Connecticut, 06518

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Lior Z. Braunstein

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Christin A. Knowlton

    Recruiting

Other trials in United States

Japan12 sites, 12 recruiting

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

    Site Public Contact, 81 78-929-1151

    Koji Matsumoto

    Recruiting

  • Gunma University Hospital

    Gunma, Maebashi, 371-8511

    Site Public Contact, 81-27-220-7626

    Sasagu Kurozumi

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Site Public Contact, 82-424-6042

    Hideo Shigematsu

    Recruiting

  • The Cancer Institute Hospital Of JFCR

    Koto-ku, Tokyo, 135-8550

    Site Public Contact, gog-jpn@insti.kitasato-u.ac.jp

    Takehiko Sakai

    Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    Site Public Contact, 81-75-751-3111

    Norikazu Masuda

    Recruiting

  • Shikoku Cancer Center

    Matsuyama, 791-0280

    Site Public Contact, 089-999-1172

    Daisuke Takabatake

    Recruiting

  • Nagoya University Hospital

    Nagoya, 466-0065

    Site Public Contact, 81 52-741-2111

    Yuko Takano

    Recruiting

  • Kindai University

    Osaka, 589 8511

    Site Public Contact, 072-366-0221

    Yoshifumi Komoike

    Recruiting

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

    Site Public Contact, 81-49-276-2028

    Akihiro Fujimoto

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Site Public Contact, hassi@med.hokudai.ac.jp

    Masato Takahashi

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104 0045

    Site Public Contact, 81-3-3542-2511, www-admin@ncc.go.jp

    Shin Takayama

    Recruiting

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

    Site Public Contact, (081) 089-964-5111

    Yoshiaki Kamei

    Recruiting

Other trials in Japan

Canada7 sites, 7 recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Site Public Contact, 613-549-6666, cc-clinicaltrials@kgh.kari.net

    Timothy Owen

    Recruiting

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Site Public Contact, 514-890-8000 ext. 12725, info.cr.chum@ssss.gouv.qc.ca

    Jean-Marc Bourque

    Recruiting

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

    Site Public Contact, rechclinique@crchuq.ulaval.ca

    Valerie Theberge

    Recruiting

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

    Site Public Contact, 306-766-2213

    Derek Suderman

    Recruiting

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

    Site Public Contact, 506-648-6890

    Farah Naz

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Site Public Contact, 306-655-2914

    Ali A. El-Gayed

    Recruiting

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Site Public Contact, 416-480-5000

    Eileen Rakovitch

    Recruiting

Other trials in Canada

Hong Kong1 site

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

    Suspended

Other trials in Hong Kong

About this study

Official title: A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer

This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

Read the detailed description

Breast conservation therapy for early stage breast cancer has been an important achievement of oncology practice in the last half century and breast radiotherapy (RT) has been essential in its development. Several seminal randomized clinical trials conducted in the 1980's era demonstrated that breast radiotherapy following lumpectomy yielded overall survival outcomes equivalent to mastectomy for treatment of early stage invasive breast cancer leading to the National Institute of Health (NIH) Consensus Conference statement in 1991 supporting breast conservation treatment.This established lumpectomy with RT as an alternative to mastectomy and subsequently the rate of breast conservation for eligible breast cancer patients rose steadily. Shortly thereafter, investigators recognized that the toxicity, patient burden, and geographic barriers associated with the protracted treatment course for breast RT was a potential barrier to breast conservation utilization. Numerous phase III clinical trials were conducted randomizing women post lumpectomy to RT vs. observation aimed at identifying which cases did not derive a significant RT benefit. No such subsets of breast cancer patients were consistently identified, thereby solidifying the standard that breast conservation required both lumpectomy and RT. Two meta-analyses by the Early Breast Cancer Trialists Collaborative Group (EBCTCG) in 2005 and 2011 further reinforced the value of breast RT post lumpectomy by examining the relationship of local recurrence and breast cancer mortality relative to the use of breast RT post lumpectomy. In each analysis, it found for axillary node negative breast cancer patients undergoing breast conservation a small but consistent increase in breast cancer mortality when breast radiotherapy was omitted. As a result, breast RT after lumpectomy has become an established paradigm for breast conservation for early stage breast cancer and is recommended by the NCCN 2018 guidelines (as it has for nearly two decades) that are commonly used today by clinicians and health systems alike. The landscape of early stage breast cancer has changed dramatically over the past three decades since the establishment of breast conservation. Widespread screening with mammography has led to the diagnosis of smaller and earlier stage disease. All breast cancers are now routinely characterized by their hormone sensitivity based on the presence of estrogen and progesterone receptors on tumor cells within the biopsy or surgical specimen and presence of HER2 (human epidermal growth factor receptor 2) which has provided an additional means of stratifying breast cancer into distinct prognostic groups. Small, node negative invasive breast cancer that is hormone sensitive (HS) and HER2-negative has a lower overall recurrence rate (local, regional, and distant) than breast cancers characterized by more adverse clinical pathologic features. However, other than in a smaller subset of women greater than 70 years old, clinical trials in this HS population still demonstrated unacceptable local recurrence risks long term after lumpectomy alone emphasizing that clinical and pathologic features are insufficient for consistently identifying when RT can safely be omitted.

Being tested
Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Other

    Post lumpectomy radiation therapy will be external beam radiation to either the whole breast + boost, partial breast irradiation, or Accelerated Partial Breast Irradiation that must begin within 12 weeks of the last breast cancer surgery(including re-excision of margins).

    Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s). Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator.

  • Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)Drug

    Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s).

Study groups in NCT04852887
Study groupRoleWhat they receive
Arm 1: Breast Radiation Therapy + Endocrine TherapyActive comparatorRadiation therapy to the breast and hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily
Receives: Other: Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Arm 2: No Breast Radiation Therapy + Endocrine TherapyActive comparatorNo radiation therapy, only hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily
Receives: Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to invasive or noninvasive IBTR.

    Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)

    Measured: 5 years

Secondary outcomes (5)

  1. Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures.

    Time from randomization to any breast procedure after the initial surgery or last follow-up (expressed as % with intact index breast)

    Measured: Through study completion, an average of 15 years.

  2. Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence.

    Time from randomization to any invasive IBTR or last follow-up (expressed as percentage of invasive IBTR-free

    Measured: 5 years

  3. Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event.

    Time from randomization to any breast cancer recurrence at a local, regional or distant site or last follow-up (expressed as percentage of recurrence-free)

    Measured: 5 years

  4. Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer).

    Time from randomization to any cancer occurring at a distant site or last follow-up (expressed as percentage of distant disease-free)

    Measured: 5 years

  5. Time from randomization to any death.

    Time from randomization to any death or last follow-up (expressed as percent surviving)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start23 Jun 2021
  3. Primary completion8 Apr 2031 (estimated)
  4. Study completionJul 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,670 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04852887
Sponsor's protocol ID
NRG-BR007
Other IDs
5U10CA180868-07, NCI-2021-00222
Acronym
DEBRA
Status last verified
Apr 2026
First submitted
16 Apr 2021
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ho AY, Bellon JR. Overcoming Resistance - Omission of Radiotherapy for Low-Risk Breast Cancer. N Engl J Med. 2023 Feb 16;388(7):652-653. doi: 10.1056/NEJMe2216133. No abstract available.

    PubMed 36791166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) in people with Stage I Breast Cancer, run by NRG Oncology at 832 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 832 sites in United States, Japan, Canada, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Director Department of Regulatory Affairs (412-339-5300, langerj@nrgoncology.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to invasive or noninvasive IBTR. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04852887, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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