RECRUITING

Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)

Quick Facts

Study Start:2023-03-13

Study Completion:2037-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05705401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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: * 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.	* 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. * Prior ipsilateral breast or thoracic RT for any condition (contralateral RT for DCIS ≥ 10 years prior to randomization is permitted). * Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active systemic lupus erythematosus, or scleroderma. * Clinicians should consider whether any conditions would make this protocol unreasonably hazardous for the patient. * Pregnancy or lactation at the time of randomization or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for patients of childbearing potential must be performed within 14 days prior to randomization.) * Use of any investigational product within 30 days prior to randomization.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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:
* 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.

* 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.
* Prior ipsilateral breast or thoracic RT for any condition (contralateral RT for DCIS ≥ 10 years prior to randomization is permitted).
* Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active systemic lupus erythematosus, or scleroderma.
* Clinicians should consider whether any conditions would make this protocol unreasonably hazardous for the patient.
* Pregnancy or lactation at the time of randomization or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for patients of childbearing potential must be performed within 14 days prior to randomization.)
* Use of any investigational product within 30 days prior to randomization.

Contacts and Locations

Study Contact

Director, Department of Regulatory Affairs

CONTACT

412-339-5300

langerj@nrgoncology.org

Norman Wolmark, MD

CONTACT

Principal Investigator

Norman Wolmark, MD

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

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

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

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 Healthpark

Venice, Florida, 34292

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 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

The Cancer Center of Hawaii-Pali Momi

'Aiea, Hawaii, 96701

United States

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813

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

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

Mission Cancer and Blood - Ankeny

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

Mission Cancer and Blood - West Des Moines

Clive, Iowa, 50325

United States

Greater Regional Medical Center

Creston, Iowa, 50801

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

Mission Cancer and Blood - Laurel

Des Moines, Iowa, 50314

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

Olathe Health Cancer Center

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

Greater Baltimore Medical Center

Baltimore, Maryland, 21204

United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014

United States

University of Maryland Shore Medical Center at Easton

Easton, Maryland, 21601

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

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

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

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805

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

United Hospital

Saint Paul, Minnesota, 55102

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

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

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

Cancer Partners of Nebraska - Pine Lake

Lincoln, Nebraska, 68516

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

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

Montefiore Medical Center-Einstein Campus

Bronx, New York, 10461

United States

Montefiore Medical Center-Weiler Hospital

Bronx, New York, 10461

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

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

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

SUNY Upstate Medical Center-Community Campus

Syracuse, New York, 13215

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

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

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

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

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

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

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

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

Collaborators and Investigators

Sponsor: NRG Oncology

Norman Wolmark, MD, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13

Study Completion Date2037-02-01

Study Record Updates

Study Start Date2023-03-13

Study Completion Date2037-02-01

Terms related to this study

Additional Relevant MeSH Terms

HER2-positive Breast Cancer