Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

December 24, 2014

Primary Completion Date

December 20, 2021

Study Completion Date

September 4, 2025

Conditions
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8Metastatic Breast CarcinomaMetastatic Malignant Neoplasm in the BoneMetastatic Malignant Neoplasm in the LiverMetastatic Malignant Neoplasm in the LungMetastatic Malignant Neoplasm in the Lymph NodesMetastatic Malignant Neoplasm in the SpinePrognostic Stage IV Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8
Interventions
RADIATION

Stereotactic Body Radiotherapy

"Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry.~* For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy.~* For a single liver metastases, patients receive a single fraction of 30 Gy.~* For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy.~* For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy.~* For spinal metastases, patients receive 1 fraction of 20 Gy.~* For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy.~* For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy."

PROCEDURE

Surgery

All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.

Trial Locations (165)

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10601

Dickstein Cancer Treatment Center, White Plains

11211

King Faisal Specialist Hospital and Research Centre, Riyadh

14642

University of Rochester, Rochester

15212

Allegheny General Hospital, Pittsburgh

15232

UPMC-Shadyside Hospital, Pittsburgh

17109

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg

18840

Guthrie Medical Group PC-Robert Packer Hospital, Sayre

19104

University of Pennsylvania/Abramson Cancer Center, Philadelphia

19611

Reading Hospital, West Reading

19713

Helen F Graham Cancer Center, Newark

21014

UM Upper Chesapeake Medical Center, Bel Air

21044

Central Maryland Radiation Oncology in Howard County, Columbia

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21204

Greater Baltimore Medical Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

23226

Bon Secours Saint Mary's Hospital, Richmond

25701

Edwards Comprehensive Cancer Center, Huntington

26506

West Virginia University Healthcare, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

27518

Rex Hematology Oncology Associates-Cary, Cary

27529

Rex Hematology Oncology Associates-Garner, Garner

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27607

Rex Hematology Oncology Associates-Blue Ridge, Raleigh

UNC Rex Healthcare, Raleigh

27614

UNC Rex Cancer Center of Wakefield, Raleigh

27710

Duke University Medical Center, Durham

28401

Novant Health Cancer Institute Radiation Oncology - Wilmington, Wilmington

Novant Health New Hanover Regional Medical Center, Wilmington

28462

Novant Cancer Institute Radiation Oncology - Supply, Supply

29303

Spartanburg Medical Center, Spartanburg

29646

Self Regional Healthcare, Greenwood

29651

Gibbs Cancer Center-Pelham, Greer

30265

CTCA at Southeastern Regional Medical Center, Newnan

30308

Emory University Hospital Midtown, Atlanta

30309

Piedmont Hospital, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

31792

Lewis Hall Singletary Oncology Center, Thomasville

31904

John B Amos Cancer Center, Columbus

32610

University of Florida Health Science Center - Gainesville, Gainesville

32806

Orlando Health Cancer Institute, Orlando

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33028

Memorial Hospital West, Pembroke Pines

33176

Miami Cancer Institute, Miami

35233

University of Alabama at Birmingham Cancer Center, Birmingham

42303

Owensboro Health Mitchell Memorial Cancer Center, Owensboro

43210

Ohio State University Comprehensive Cancer Center, Columbus

43560

ProMedica Flower Hospital, Sylvania

44106

Case Western Reserve University, Cleveland

44307

Cleveland Clinic Akron General, Akron

46016

Ascension Saint Vincent Anderson, Anderson

46601

Memorial Hospital of South Bend, South Bend

46805

Parkview Hospital Randallia, Fort Wayne

46845

Parkview Regional Medical Center, Fort Wayne

47303

IU Health Ball Memorial Hospital, Muncie

48038

Henry Ford Macomb Hospital-Clinton Township, Clinton Township

48073

William Beaumont Hospital-Royal Oak, Royal Oak

48098

GenesisCare USA - Troy, Troy

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48183

Henry Ford Cancer Institute-Downriver, Brownstown

48202

Henry Ford Hospital, Detroit

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48334

Michigan Healthcare Professionals Farmington, Farmington Hills

48341

Saint Joseph Mercy Oakland, Pontiac

48346

Michigan Healthcare Professionals Clarkston, Clarkston

49007

West Michigan Cancer Center, Kalamazoo

53095

Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend

53226

Medical College of Wisconsin, Milwaukee

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54303

Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay

54476

Diagnostic and Treatment Center, Weston

54482

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54601

Gundersen Lutheran Medical Center, La Crosse

55101

Regions Hospital, Saint Paul

55433

Mercy Hospital, Coon Rapids

55805

Saint Luke's Hospital of Duluth, Duluth

55905

Mayo Clinic in Rochester, Rochester

58501

Sanford Bismarck Medical Center, Bismarck

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

59901

Kalispell Regional Medical Center, Kalispell

60099

Midwestern Regional Medical Center, Zion

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60153

Loyola University Medical Center, Maywood

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61636

Methodist Medical Center of Illinois, Peoria

61801

Carle Cancer Center, Urbana

62226

Southwest Illinois Health Services LLP, Swansea

62526

Decatur Memorial Hospital, Decatur

62781

Memorial Medical Center, Springfield

63110

Washington University School of Medicine, St Louis

63128

Mercy Hospital South, St Louis

63131

Missouri Baptist Medical Center, St Louis

63703

Saint Francis Medical Center, Cape Girardeau

67214

Ascension Via Christi Hospitals Wichita, Wichita

68198

University of Nebraska Medical Center, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77030

M D Anderson Cancer Center, Houston

78705

Texas Oncology-Austin Midtown, Austin

80045

UCHealth University of Colorado Hospital, Aurora

80524

Poudre Valley Hospital, Fort Collins

80539

McKee Medical Center, Loveland

80907

Penrose-Saint Francis Healthcare, Colorado Springs

80909

UCHealth Memorial Hospital Central, Colorado Springs

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84405

Ogden Regional Medical Center, Ogden

85338

CTCA at Western Regional Medical Center, Goodyear

85381

Arizona Center for Cancer Care-Peoria, Peoria

85719

Banner University Medical Center - Tucson, Tucson

87102

Lovelace Medical Center-Saint Joseph Square, Albuquerque

University of New Mexico Cancer Center, Albuquerque

87109

Lovelace Radiation Oncology, Albuquerque

New Mexico Oncology Hematology Consultants, Albuquerque

87505

Christus Saint Vincent Regional Cancer Center, Santa Fe

89502

Renown Regional Medical Center, Reno

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

92093

UC San Diego Moores Cancer Center, La Jolla

92134

Naval Medical Center -San Diego, San Diego

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

94080

Kaiser Permanente Cancer Treatment Center, South San Francisco

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

95204

Saint Joseph's Medical Center, Stockton

95678

The Permanente Medical Group-Roseville Radiation Oncology, Roseville

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96161

Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee

96813

Queen's Medical Center, Honolulu

96817

The Cancer Center of Hawaii-Liliha, Honolulu

97030

Legacy Mount Hood Medical Center, Gresham

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

98686

Legacy Salmon Creek Hospital, Vancouver

32224-9980

Mayo Clinic in Florida, Jacksonville

04530

MaineHealth Coastal Cancer Treatment Center, Bath

04005

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford, Biddeford

04102

Maine Medical Center-Bramhall Campus, Portland

04073

MaineHealth Cancer Care Center of York County, Sanford

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford, Sanford

04074

Maine Medical Center- Scarborough Campus, Scarborough

01805

Lahey Hospital and Medical Center, Burlington

01854

Lowell General Hospital, Lowell

03820

Wentworth-Douglass Hospital, Dover

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

08060

Virtua Memorial, Mount Holly

08755

Community Medical Center, Toms River

08043

Virtua Voorhees, Voorhees Township

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

N6A 4L6

London Regional Cancer Program, London

K1H 8L6

Ottawa Hospital and Cancer Center-General Campus, Ottawa

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H2W 1S6

McGill University Department of Oncology, Montreal

H2X 3E4

CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal

H3H 2R9

The Research Institute of the McGill University Health Centre (MUHC), Montreal

H3T 1E2

Jewish General Hospital, Montreal

120-752

Yonsei University Health System-Severance Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER