Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

PHASE3CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

September 15, 2006

Primary Completion Date

July 1, 2014

Study Completion Date

July 2, 2014

Conditions
Estrogen Receptor PositiveHER2 Positive Breast CarcinomaHER2/Neu NegativeProgesterone Receptor PositiveRecurrent Breast CarcinomaStage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Stage IV Breast Cancer AJCC v6 and v7
Interventions
DRUG

Fulvestrant

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lapatinib Ditosylate

Given PO

OTHER

Placebo Administration

Given PO

Trial Locations (368)

10065

Memorial Sloan Kettering Cancer Center, New York

10305

Staten Island University Hospital, Staten Island

10549

Northern Westchester Hospital, Mount Kisco

13057

Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

18015

Saint Luke's University Hospital-Bethlehem Campus, Bethlehem

19001

Abington Memorial Hospital, Abington

19047

Saint Mary Medical and Regional Cancer Center, Langhorne

19718

Christiana Care Health System-Christiana Hospital, Newark

19958

Beebe Medical Center, Lewes

20007

MedStar Georgetown University Hospital, Washington D.C.

20016

Sibley Memorial Hospital, Washington D.C.

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21204

Greater Baltimore Medical Center, Baltimore

21229

Saint Agnes Hospital, Baltimore

21601

University of Maryland Shore Medical Center at Easton, Easton

21701

Frederick Memorial Hospital, Frederick

21921

Union Hospital of Cecil County, Elkton

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

24273

Southwest VA Regional Cancer Center, Norton

24541

Danville Regional Medical Center, Danville

27157

Wake Forest University Health Sciences, Winston-Salem

27534

Southeastern Medical Oncology Center-Goldsboro, Goldsboro

Wayne Memorial Hospital, Goldsboro

27536

Maria Parham Hospital, Henderson

27565

Granville Medical Center, Oxford

27573

Person Memorial Hospital, Roxboro

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27609

Duke Raleigh Hospital, Raleigh

27710

Duke University Medical Center, Durham

28054

CaroMont Regional Medical Center, Gastonia

28139

Rutherford Hospital, Rutherfordton

28358

Southeastern Regional Medical Center, Lumberton

28374

FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst

28501

Vidant Oncology-Kinston, Kinston

28791

Margaret R Pardee Memorial Hospital, Hendersonville

28801

Mission Hospital, Asheville

29303

Spartanburg Medical Center, Spartanburg

29601

Saint Francis Hospital, Greenville

29615

Prisma Health Cancer Institute - Eastside, Greenville

29621

AnMed Health Hospital, Anderson

33486

Boca Raton Regional Hospital, Boca Raton

37660

Wellmont Holston Valley Hospital and Medical Center, Kingsport

37920

University of Tennessee - Knoxville, Knoxville

38163

University of Tennessee Health Science Center, Memphis

39216

University of Mississippi Medical Center, Jackson

39534

Keesler Medical Center, Keesler Air Force Base

40215

Doctors Carrol, Sheth, Raghavan, Louisville

43015

Grady Memorial Hospital, Delaware

43055

Licking Memorial Hospital, Newark

43081

Saint Ann's Hospital, Westerville

43130

Fairfield Medical Center, Lancaster

43214

Riverside Methodist Hospital, Columbus

43215

Grant Medical Center, Columbus

43222

Mount Carmel Health Center West, Columbus

43228

Doctors Hospital, Columbus

43311

Mary Rutan Hospital, Bellefontaine

43701

Genesis Healthcare System Cancer Care Center, Zanesville

44106

Case Western Reserve University, Cleveland

44131

Cleveland Clinic Cancer Center Independence, Independence

44195

Cleveland Clinic Foundation, Cleveland

44307

Cleveland Clinic Akron General, Akron

44691

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster

44710

Aultman Health Foundation, Canton

45177

Clinton Memorial Hospital, Wilmington

45373

Upper Valley Medical Center, Troy

45385

Greene Memorial Hospital, Xenia

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital - Dayton, Dayton

45409

Miami Valley Hospital, Dayton

45415

Miami Valley Hospital North, Dayton

45428

Dayton Veterans Affairs Medical Center, Dayton

45429

Kettering Medical Center, Kettering

45505

Springfield Regional Medical Center, Springfield

45601

Adena Regional Medical Center, Chillicothe

45750

Marietta Memorial Hospital, Marietta

45801

Saint Rita's Medical Center, Lima

45840

Blanchard Valley Hospital, Findlay

46107

Franciscan Saint Francis Health-Beech Grove, Beech Grove

46219

Community Cancer Center East, Indianapolis

46256

Community Cancer Center North, Indianapolis

46350

IU Health La Porte Hospital, La Porte

46360

Franciscan Saint Anthony Health-Michigan City, Michigan City

46515

Elkhart General Hospital, Elkhart

46526

Goshen Center for Cancer Care, Goshen

46545

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka

46601

Memorial Hospital of South Bend, South Bend

Michiana Hematology Oncology PC-South Bend, South Bend

46628

Northern Indiana Cancer Research Consortium, South Bend

46845

Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne

46904

Community Howard Regional Health, Kokomo

47374

Reid Health, Richmond

48073

William Beaumont Hospital-Royal Oak, Royal Oak

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48670

Mid-Michigan Medical Center - Midland, Midland

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49048

Borgess Medical Center, Kalamazoo

49085

Lakeland Medical Center Saint Joseph, Saint Joseph

Marie Yeager Cancer Center, Saint Joseph

Oncology Care Associates PLLC, Saint Joseph

49307

Spectrum Health Big Rapids Hospital, Big Rapids

49423

Holland Community Hospital, Holland

49442

Mercy Health Partners-Hackley Campus, Muskegon

49444

Mercy Health Mercy Campus, Muskegon

49503

Cancer Research Consortium of West Michigan NCORP, Grand Rapids

Mercy Health Saint Mary's, Grand Rapids

Spectrum Health at Butterworth Campus, Grand Rapids

49519

Metro Health Hospital, Wyoming

49684

Munson Medical Center, Traverse City

49801

Green Bay Oncology - Iron Mountain, Iron Mountain

49829

Green Bay Oncology - Escanaba, Escanaba

50010

McFarland Clinic PC - Ames, Ames

50307

Mercy Capitol, Des Moines

50309

Iowa Methodist Medical Center, Des Moines

Iowa-Wide Oncology Research Coalition NCORP, Des Moines

Medical Oncology and Hematology Associates-Des Moines, Des Moines

50314

Medical Oncology and Hematology Associates-Laurel, Des Moines

Mercy Medical Center - Des Moines, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

50325

Medical Oncology and Hematology Associates-West Des Moines, Clive

50401

Mercy Medical Center - North Iowa, Mason City

51101

Siouxland Regional Cancer Center, Sioux City

51102

Mercy Medical Center-Sioux City, Sioux City

51104

Saint Luke's Regional Medical Center, Sioux City

51503

Heartland Oncology and Hematology LLP, Council Bluffs

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

52403

Mercy Hospital, Cedar Rapids

Oncology Associates at Mercy Medical Center, Cedar Rapids

52501

Ottumwa Regional Health Center, Ottumwa

52722

University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf

52803

Genesis Medical Center - East Campus, Davenport

52804

Genesis Cancer Care Institute, Davenport

53548

Mercyhealth Hospital and Cancer Center - Janesville, Janesville

53717

Dean Hematology and Oncology Clinic, Madison

54143

Bay Area Medical Center, Marinette

54154

Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls

54221

Holy Family Memorial Hospital, Manitowoc

54235

Green Bay Oncology - Sturgeon Bay, Sturgeon Bay

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54303

Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay

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

54601

Gundersen Lutheran Medical Center, La Crosse

55101

Regions Hospital, Saint Paul

55102

Saint Joseph's Hospital - Healtheast, Saint Paul

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology Hematology PA-Woodbury, Woodbury

Woodwinds Health Campus, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55350

Hutchinson Area Health Care, Hutchinson

55355

Meeker County Memorial Hospital, Litchfield

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, Minneapolis

Virginia Piper Cancer Institute, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55422

North Memorial Medical Health Center, Robbinsdale

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview-Southdale Hospital, Edina

55805

Essentia Health Cancer Center, Duluth

Essentia Health Saint Mary's Medical Center, Duluth

Miller-Dwan Hospital, Duluth

Saint Luke's Hospital of Duluth, Duluth

56201

Rice Memorial Hospital, Willmar

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

57105

Avera McKennan Hospital and University Health Center, Sioux Falls

Medical X-Ray Center, Sioux Falls

57401

Avera Cancer Institute-Aberdeen, Aberdeen

57701

Rapid City Regional Hospital, Rapid City

58201

Altru Cancer Center, Grand Forks

58501

Mid Dakota Clinic, Bismarck

Saint Alexius Medical Center, Bismarck

Sanford Bismarck Medical Center, Bismarck

58701

Trinity Cancer Care Center, Minot

59101

Billings Clinic Cancer Center, Billings

Northern Rockies Radiation Oncology Center, Billings

Saint Vincent Healthcare, Billings

59102

Montana Cancer Consortium NCORP, Billings

Saint Vincent Frontier Cancer Center, Billings

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

Berdeaux, Donald MD (UIA Investigator), Great Falls

Great Falls Clinic, Great Falls

59601

Saint Peter's Community Hospital, Helena

59701

Saint James Community Hospital and Cancer Treatment Center, Butte

59715

Bozeman Deaconess Hospital, Bozeman

59802

Montana Cancer Specialists, Missoula

Saint Patrick Hospital - Community Hospital, Missoula

59804

Community Medical Hospital, Missoula

Guardian Oncology and Center for Wellness, Missoula

59901

Glacier Oncology PLLC, Kalispell

Kalispell Medical Oncology, Kalispell

Kalispell Regional Medical Center, Kalispell

60153

Loyola University Medical Center, Maywood

60305

West Suburban Medical Center, River Forest

60435

Joliet Oncology-Hematology Associates Limited, Joliet

60504

Rush - Copley Medical Center, Aurora

60525

AMITA Health Adventist Medical Center, La Grange

60612

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

60901

Presence Saint Mary's Hospital, Kankakee

61108

OSF Saint Anthony Medical Center, Rockford

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

Ottawa Regional Hospital and Healthcare Center, Ottawa

61354

Illinois Valley Hospital, Peru

Valley Radiation Oncology, Peru

61356

Perry Memorial Hospital, Princeton

61362

Saint Margaret's Hospital, Spring Valley

61401

Galesburg Cottage Hospital, Galesburg

Illinois CancerCare-Galesburg, Galesburg

Western Illinois Cancer Treatment Center, Galesburg

61443

Kewanee Hospital, Kewanee

61455

Mcdonough District Hospital, Macomb

61520

Graham Hospital Association, Canton

61530

Eureka Hospital, Eureka

61554

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin

Pekin Hospital, Pekin

61614

Proctor Hospital, Peoria

61615

Illinois CancerCare-Peoria, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61701

Saint Joseph Medical Center, Bloomington

61747

Hopedale Medical Complex - Hospital, Hopedale

61761

Bromenn Regional Medical Center, Normal

Community Cancer Center Foundation, Normal

61801

Carle Cancer Center, Urbana

62002

Saint Anthony's Health, Alton

62321

Memorial Hospital, Carthage

62526

Decatur Memorial Hospital, Decatur

Heartland Cancer Research NCORP, Decatur

62644

Mason District Hospital, Havana

62781

Memorial Medical Center, Springfield

62864

Good Samaritan Regional Health Center, Mount Vernon

63017

Saint Luke's Hospital, Chesterfield

63110

Washington University School of Medicine, St Louis

63131

Missouri Baptist Medical Center, St Louis

63141

Center for Cancer Care and Research, St Louis

Mercy Hospital Saint Louis, St Louis

Saint Louis-Cape Girardeau CCOP, St Louis

63701

Southeast Missouri Hospital, Cape Girardeau

63703

Saint Francis Medical Center, Cape Girardeau

64804

Freeman Health System, Joplin

65201

Missouri Cancer Associates, Columbia

65212

University of Missouri - Ellis Fischel, Columbia

66044

Lawrence Memorial Hospital, Lawrence

66160

University of Kansas Cancer Center, Kansas City

66606

Cotton O'Neil Cancer Center / Stormont Vail Health, Topeka

66701

Cancer Center of Kansas - Fort Scott, Fort Scott

66720

Cancer Center of Kansas - Chanute, Chanute

66762

Via Christi Hospital-Pittsburg, Pittsburg

67003

Hospital District Sixth of Harper County, Anthony

67042

Cancer Center of Kansas - El Dorado, El Dorado

67068

Cancer Center of Kansas-Kingman, Kingman

67114

Cancer Center of Kansas - Newton, Newton

67124

Cancer Center of Kansas - Pratt, Pratt

67152

Cancer Center of Kansas - Wellington, Wellington

67156

Cancer Center of Kansas - Winfield, Winfield

67208

Associates In Womens Health, Wichita

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita

67214

Ascension Via Christi Hospitals Wichita, Wichita

Cancer Center of Kansas - Wichita, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas - Parsons, Parsons

67401

Cancer Center of Kansas - Salina, Salina

67801

Cancer Center of Kansas - Dodge City, Dodge City

67901

Southwest Medical Center, Liberal

67905

Cancer Center of Kansas-Liberal, Liberal

68114

Nebraska Methodist Hospital, Omaha

70112

Louisiana State University Health Science Center, New Orleans

University Medical Center New Orleans, New Orleans

70806

Baton Rouge General Medical Center, Baton Rouge

70809

Mary Bird Perkins Cancer Center, Baton Rouge

72205

University of Arkansas for Medical Sciences, Little Rock

80524

Poudre Valley Hospital, Fort Collins

80909

UCHealth Memorial Hospital Central, Colorado Springs

82801

Welch Cancer Center, Sheridan

83201

Portneuf Medical Center, Pocatello

83712

Saint Luke's Mountain States Tumor Institute, Boise

84003

American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork

84103

Intermountain Health Care, Salt Lake City

84106

Utah Cancer Specialists-Salt Lake City, Salt Lake City

84107

Cottonwood Hospital Medical Center, Murray

Intermountain Medical Center, Murray

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84321

Logan Regional Hospital, Logan

84403

McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center, Provo

84720

Sandra L Maxwell Cancer Center, Cedar City

84770

Dixie Medical Center Regional Cancer Center, St. George

89102

University Medical Center of Southern Nevada, Las Vegas

91204

Glendale Memorial Hospital and Health Center, Glendale

91505

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank

92108

Kaiser Permanente-San Diego Mission, San Diego

93420

Arroyo Grande Community, Arroyo Grande

PCR Oncology, Arroyo Grande

93901

Salinas Valley Memorial, Salinas

94040

El Camino Hospital, Mountain View

Palo Alto Medical Foundation-Camino Division, Mountain View

94110

Zuckerberg San Francisco General Hospital, San Francisco

94115

UCSF Medical Center-Mount Zion, San Francisco

94538

Valley Medical Oncology Consultants-Fremont, Fremont

94545

Saint Rose Hospital, Hayward

94546

East Bay Radiation Oncology Center, Castro Valley

Eden Hospital Medical Center, Castro Valley

Valley Medical Oncology Consultants-Castro Valley, Castro Valley

94588

Valley Care Health System - Pleasanton, Pleasanton

Valley Medical Oncology Consultants, Pleasanton

94602

Highland General Hospital, Oakland

94608

Bay Area Breast Surgeons Inc, Emeryville

94609

Alta Bates Summit Medical Center - Summit Campus, Oakland

Bay Area Tumor Institute, Oakland

Hematology and Oncology Associates-Oakland, Oakland

Tom K Lee Inc, Oakland

94806

Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo

95687

Northbay Cancer Center, Vacaville

95817

University of California Davis Comprehensive Cancer Center, Sacramento

95901

Fremont - Rideout Cancer Center, Marysville

96161

Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee

98104

Minor and James Medical PLLC, Seattle

98112

Kaiser Permanente Washington, Seattle

98195

University of Washington Medical Center, Seattle

98225

PeaceHealth Saint Joseph Medical Center, Bellingham

98274

Skagit Valley Hospital, Mount Vernon

98310

Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton

98801

Wenatchee Valley Hospital and Clinics, Wenatchee

99202

Cancer Care Northwest - Spokane South, Spokane

99218

Evergreen Hematology and Oncology PS, Spokane

99336

Kadlec Clinic Hematology and Oncology, Kennewick

06606

Saint Vincent's Medical Center, Bridgeport

06520

Yale University, New Haven

06790

Smilow Cancer Hospital-Torrington Care Center, Torrington

06708

Harold Leever Regional Cancer Center, Waterbury

46514-2098

Elkhart Clinic, Elkhart

04401

Eastern Maine Medical Center, Bangor

03909

York Hospital, York Village

02115

Brigham and Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

02721

Saint Anne's Hospital, Fall River

01930

Addison Gilbert Hospital, Gloucester

01854

Lowell General Hospital, Lowell

01655

UMass Memorial Medical Center - University Campus, Worcester

03301

New Hampshire Oncology Hematology PA-Concord, Concord

03106

New Hampshire Oncology Hematology PA-Hooksett, Hooksett

03246

LRGHealthcare-Lakes Region General Hospital, Laconia

03103

Elliot Hospital, Manchester

08103

Cooper Hospital University Medical Center, Camden

07039

Saint Barnabas Medical Center, Livingston

07960

Morristown Medical Center, Morristown

08060

Virtua Memorial, Mount Holly

07902

Overlook Hospital, Summit

08629

Saint Francis Medical Center, Trenton

08360

Inspira Medical Center Vineland, Vineland

08043

Virtua Voorhees, Voorhees Township

45005-1066

Atrium Medical Center-Middletown Regional Hospital, Franklin

45433-5529

Wright-Patterson Medical Center, Wright-Patterson Air Force Base

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05405

University of Vermont and State Agricultural College, Burlington

98122-4307

Swedish Medical Center-First Hill, Seattle

54301-3526

Green Bay Oncology at Saint Vincent Hospital, Green Bay

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00390455 - Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive | Biotech Hunter | Biotech Hunter