Zapping tumors with precision radiation may help control limited metastatic breast cancer

NCT ID NCT02364557

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looked at whether adding focused radiation (SBRT) or surgery to standard treatments like chemo or hormone therapy helps people with breast cancer that has spread to just one or two places. 129 participants were randomly assigned to get standard care alone or standard care plus radiation/surgery. The goal was to see if the extra treatments could delay the cancer from growing or improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Stereotactic body radiotherapy (SBRT) and/or surgical ablation
What this could lead to: If it works, this could show that treating each tumor directly with radiation or surgery helps people with limited metastatic breast cancer live longer or delay the cancer from growing.
What could go wrong: This is a relatively small, completed trial (129 participants) and results may not apply to everyone. Adding radiation or surgery also carries risks like damage to nearby organs or surgical complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

129 people

The number who actually took part.

Started

Dec 2014

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A patient cannot be considered eligible for this study unless all of the following conditions are met. * Pathologically confirmed metastatic breast cancer * Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis; * Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification * Number of allowable metastases: * =\< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites: * Peripheral lung * Osseous (bone) * Spine * Central lung * Abdominal-pelvic metastases (lymph node/adrenal gland) * Liver * Mediastinal/cervical lymph node * All known disease amenable to metastasis-directed therapy with either SBRT or resection * Note: Symptomatic bone metastasis are allowed if ablative therapy can be delivered * Note: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites * Note: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy * Maximum diameter of individual metastasis in any dimension =\< 5 cm * There are no restrictions on distance between the metastases * Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy \[surgery or SBRT\] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician) * The primary tumor site must be controlled prior to registration * For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration * The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration * The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference * Appropriate stage for study entry based on the following diagnostic workup: * History/physical examination within 60 days prior to registration * Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration * Zubrod performance status =\< 2 within 60 days prior to registration * Blood cell count (CBC)/differential obtained within 60 days prior to registration on study * Absolute neutrophil count (ANC) \>= 500 cells/mm\^3 * Platelets \>= 50,000 cells/mm\^3 * Hemoglobin \>= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable) * For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Exclusion Criteria: * Patients with any of the following conditions are NOT eligible for this study. * Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration; * Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported * Metastases with indistinct borders making targeting not feasible * Note: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required * Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals) * Metastases located within 3 cm of the previously irradiated structures: * Spinal cord previously irradiated to \> 40 Gy (delivered in =\< 3 Gy/fraction) * Brachial plexus previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction) * Small intestine, large intestine, or stomach previously irradiated to \> 45 Gy (delivered in =\< 3 Gy/fraction) * Brainstem previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction) * Whole lung previously irradiated with prior percent volume receiving greater than or equal to 20 Gy (V20Gy)\> 30% (delivered in =\< 3 Gy/fraction) * Primary tumor irradiated with SBRT * Metastasis irradiated with SBRT * Brain metastases * Exudative, bloody, or cytological proven malignant effusions * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible * Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a cluster of differentiation 4 (CD4) count \>= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm liver cancer Lymphatic Metastasis metastatic carcinoma in the bone metastatic malignant neoplasm metastatic malignant neoplasm in the lymph nodes metastatic malignant neoplasm in the spinal cord metastatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anatomic stage IV breast cancer ajcc V8 Anatomic stage IV breast cancer american joint committee on cancer (AJCC) V8 Metastatic breast carcinoma Metastatic malignant neoplasm in the bone Metastatic malignant neoplasm in the liver Metastatic malignant neoplasm in the lung Metastatic malignant neoplasm in the lymph nodes Metastatic malignant neoplasm in the spine Prognostic stage IV breast cancer ajcc V8

Contacts and locations

Locations

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States
Arizona Center for Cancer Care-Peoria

Peoria, Arizona, 85381, United States
Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada
Ascension Saint Vincent Anderson

Anderson, Indiana, 46016, United States
Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States
Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23226, United States
CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada
CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States
CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States
Christus Saint Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505, United States
Cleveland Clinic Akron General

Akron, Ohio, 44307, United States
Community Medical Center

Toms River, New Jersey, 08755, United States
Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States
Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Dickstein Cancer Treatment Center

White Plains, New York, 10601, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States
Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States
Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States
Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
John B Amos Cancer Center

Columbus, Georgia, 31904, United States
Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States
King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia
Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States
Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States
Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States
Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States
Lewis Hall Singletary Oncology Center

Thomasville, Georgia, 31792, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
London Regional Cancer Program

London, Ontario, N6A 4L6, Canada
Los Angeles General Medical Center

Los Angeles, California, 90033, United States
Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, 87102, United States
Lovelace Radiation Oncology

Albuquerque, New Mexico, 87109, United States
Lowell General Hospital

Lowell, Massachusetts, 01854, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States
MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, 04073, United States
MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530, United States
MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, 04005, United States
MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States
MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Hospital West

Pembroke Pines, Florida, 33028, United States
Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Hospital South

St Louis, Missouri, 63128, United States
Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, 48346, United States
Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, 48334, United States
Michigan Healthcare Professionals Troy

Troy, Michigan, 48098, United States
Midwestern Regional Medical Center

Zion, Illinois, 60099, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States
Naval Medical Center -San Diego

San Diego, California, 92134, United States
New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern University

Chicago, Illinois, 60611, United States
Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, 28462, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, 28401, United States
Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States
Ogden Regional Medical Center

Ogden, Utah, 84405, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Orlando Health Cancer Institute

Orlando, Florida, 32806, United States
Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, K1H 8L6, Canada
Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, 42303, United States
Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States
Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Rex Hematology Oncology Associates-Blue Ridge

Raleigh, North Carolina, 27607, United States
Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint Joseph's Medical Center

Stockton, California, 95204, United States
Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States
Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Self Regional Healthcare

Greenwood, South Carolina, 29646, United States
Southwest Illinois Health Services LLP

Swansea, Illinois, 62226, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
Sutter Medical Center Sacramento

Sacramento, California, 95816, United States
Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States
The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States
The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States
The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada
Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States
UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States
UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States
UNC Health Cancer Care Cary

Cary, North Carolina, 27518, United States
UNC Health Cancer Care Garner

Garner, North Carolina, 27529, United States
UNC Health Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States
UNC Health Cancer Care Wakefield

Raleigh, North Carolina, 27614, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States
UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
Virtua Memorial

Mount Holly, New Jersey, 08060, United States
Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wentworth-Douglass Hospital

Dover, New Hampshire, 03820, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States
Yonsei University Health System-Severance Hospital

Seoul, 120-752, South Korea

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