Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
HERO
A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)
3 other identifiers
interventional
1,300
2 countries
418
Brief Summary
This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2023
Longer than P75 for phase_3
418 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
May 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2037
April 27, 2026
April 1, 2026
10.7 years
January 5, 2023
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence-free interval (RFI)
Time to recurrence event or censoring
From randomization to first recurrence event or censoring for the duration of the trial, at 10.5 years
Secondary Outcomes (7)
ipsilateral breast recurrence (IBR) for radiation omitting arm
From randomization to first recurrence event or censoring for the duration of the trial , measured at year 7
ipsilateral breast recurrence (IBR) by treatment arm
From randomization to first recurrence event or censoring for the duration of the trial at 10.5 years.
local regional recurrence (LRR) by treatment arm
From randomization to first recurrence event or censoring for the duration of the trial at 10.5 years.
disease-free survival (DFS) by treatment arm.
From the time of randomization for the duration of the trial at 10.5 years.
overall survival (OS) by treatment arm.
From the time of randomization for the duration of the trial at 10.5 years.
- +2 more secondary outcomes
Study Arms (2)
Standard of Care Adjuvant Breast Radiation
ACTIVE COMPARATORPatients continue to receive their current planned adjuvant breast radiation and systemic HER2-targeted therapies
Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
ACTIVE COMPARATORPatients continue to receive their current systemic HER2-targeted therapy without breast adjuvant radiation
Interventions
participants are randomized to continue their standard of care systemic HER2-targeted therapy without adjuvant breast radiotherapy
adjuvant breast radiotherapy per the current standard of care
Eligibility Criteria
You may qualify if:
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
- female and male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy.
- ≥ 40 years of age
- ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60
- Histologically or cytologically confirmed invasive breast carcinoma.
- tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
- Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0).
- The following staging criteria must be met according to AJCC 8th edition criteria:
- Adjuvant cohort : By pathologic evaluation, the patient's primary tumor must be \</= 2 cm and ipsilateral nodes must be pN0. Surgical lumpectomy margins must be negative for invasive cancer and ductal carcinoma in situ (no ink on tumor).
- Neoadjuvant cohort: Prior to neoadjuvant therapy, the patient's primary tumor must be \< 3 cm by imaging studies, with negative axillary nodes (cN0) based on axillary U/S, CT, PET or MRI. Physical examination is not sufficient documentation of cN0 status; • Must be ypT0N0 at surgery (lumpectomy); patients with residual non-invasive disease (DCIS) in the surgical specimen (ypTis), are NOT eligible.
- For the Adjuvant cohort, adjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy.
- For the Neoadjuvant cohort, neoadjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy.- ; Patients who did not receive chemotherapy in the neoadjuvant setting are not eligible, even if they achieved pCR with their preoperative treatment; nor would these patients become eligible by receiving chemotherapy after surgery.
- In patients assigned to radiation therapy, treatment should start ≤ 12 weeks from surgery on the Neoadjuvant cohort and ≤ 8 weeks from the completion of chemotherapy on the Adjuvant cohort. Patients should continue HER2-targeted therapy during assigned study treatment (radiation or observation).
- Bilateral mammogram or MRI within 52 weeks prior to randomization.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
You may not qualify if:
- Definitive clinical or radiologic evidence of metastatic disease.
- On the Adjuvant cohort, patients with a primary tumor \>2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor \> 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination.
- Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease.
- Patient planning for or status-post mastectomy.
- Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease.
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by \> 4 centimeters. If multifocal, all foci should be confined to a maximum tumor bed of 3 cm determined by pathological assessment.
- Paget's disease of the nipple.
- Synchronous (unilateral or bilateral) invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
- On the Adjuvant cohort, 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.
- Patients treated for a prior invasive breast malignancy are excluded. Contralateral DCIS ≥ 10 years prior to enrollment is permissible.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible unless discontinued prior to randomization.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
- Alliance for Clinical Trials in Oncologycollaborator
- Eastern Cooperative Oncology Groupcollaborator
- SWOG Cancer Research Networkcollaborator
Study Sites (418)
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538, United States
Fresno Cancer Center
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Memorial Medical Center
Modesto, California, 95355, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Ridley-Tree Cancer Center
Santa Barbara, California, 93105, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086, United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California, 91356, United States
City of Hope South Bay
Torrance, California, 90503, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
City of Hope Upland
Upland, California, 91786, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
John Fitzgerald Kennedy Medical Center
Atlantis, Florida, 33462, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Lee Memorial Health System
Fort Myers, Florida, 33901, United States
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905, United States
Sarasota Memorial Hospital-Venice
N. Venice, Florida, 34275, United States
Health Central
Ocoee, Florida, 34761, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
GenesisCare USA - Plantation
Plantation, Florida, 33324, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
Intercoastal Medical Group - Cattleridge II
Sarasota, Florida, 34232, United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, 34236, United States
First Physicians Group - Urology Robotic and Minimally Invasive Surgery
Sarasota, Florida, 34239, United States
First Physicians Group-Sarasota
Sarasota, Florida, 34239, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, 34243, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, 34275, United States
Florida Cancer Specialists - Venice Island
Venice, Florida, 34285, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Emory Decatur Hospital
Decatur, Georgia, 30033, United States
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Saint Mary's Hospital
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307, United States
Northwest Oncology LLC
Dyer, Indiana, 46311, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342, United States
Saint Mary Medical Center
Hobart, Indiana, 46342, United States
The Community Hospital
Munster, Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
UM Capital Region Medical Center
Largo, Maryland, 20774, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Michigan Healthcare Professionals Macomb
Macomb, Michigan, 48044, United States
Michigan Healthcare Professionals Madison Heights
Madison Heights, Michigan, 48071, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437, United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, 11740, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126, United States
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, 13126, United States
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606, United States
Highland Hospital
Rochester, New York, 14620, United States
Pluta Cancer Center
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Upstate Cancer Center at Verona
Verona, New York, 13478, United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Kent Hospital
Warwick, Rhode Island, 02886, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
MD Anderson League City
League City, Texas, 77573, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
Farmington Health Center
Farmington, Utah, 84025, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060, Puerto Rico
Doctors Cancer Center
Manati, 00674, Puerto Rico
San Juan Community Oncology Group
San Juan, 00917, Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
San Juan City Hospital
San Juan, 00936, Puerto Rico
Related Publications (1)
Braunstein LZ, Mitchell MP, Bandos H, Sikov WM, Khan AJ, Chen PY, Ganz PA, Jagsi R, White JR, Cecchini RS, Kang H, Puhalla SL, Bolton KL, Connolly EP, Stringer-Reasor EM, Gergelis KR, Julian TB, Mamounas EP, Wolmark N. NRG-BR008/HERO study: a Phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer. Future Oncol. 2025 Jul;21(16):2017-2025. doi: 10.1080/14796694.2025.2511586. Epub 2025 Jun 26.
PMID: 40574381DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Wolmark, MD
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2023
First Posted
January 30, 2023
Study Start
May 19, 2023
Primary Completion (Estimated)
February 1, 2034
Study Completion (Estimated)
February 1, 2037
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share