S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer

NACompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

November 1, 2011

Primary Completion Date

August 31, 2017

Study Completion Date

September 30, 2017

Conditions
brca1 Mutation Carrierbrca2 Mutation CarrierBreast Cancer
Interventions
DIETARY_SUPPLEMENT

cholecalciferol

Given orally

OTHER

placebo

Given orally

Trial Locations (360)

10032

Columbia University/Herbert Irving Cancer Center, New York

11501

Winthrop University Hospital, Mineola

13021

Hematology Oncology Associates of Central New York-Auburn, Auburn

13057

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

13210

State University of New York Upstate Medical University, Syracuse

13215

Hematology Oncology Associates of Central New York-Onondaga Hill, Syracuse

13440

Hematology Oncology Associates of Central New York-Rome, Rome

14620

Highland Hospital, Rochester

14642

University of Rochester, Rochester

19460

Phoenixville Hospital, Phoenixville

24740

Princeton Community Hospital, Princeton

27104

Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem

27203

Randolph Hospital, Asheboro

27320

Annie Penn Memorial Hospital, Reidsville

27403

Cone Health Cancer Center, Greensboro

28078

Southern Oncology Specialists-Huntersville, Huntersville

28105

Novant Health Cancer Specialists-Matthews, Matthews

28117

Lake Norman Hematology Oncology Specialists-Mooresville, Mooresville

28204

Novant Health Presbyterian Medical Center, Charlotte

28262

Southern Oncology Specialists-Charlotte, Charlotte

28791

Hendersonville Hematology and Oncology at Pardee, Hendersonville

Margaret R Pardee Memorial Hospital, Hendersonville

28792

Park Ridge Hospital Breast Health Center, Hendersonville

29303

Spartanburg Medical Center, Spartanburg

29307

Greenville Health System Cancer Institute-Spartanburg, Spartanburg

29506

McLeod Regional Medical Center, Florence

29601

Saint Francis Hospital, Greenville

29605

Greenville Health System Cancer Institute-Andrews, Greenville

Greenville Health System Cancer Institute-Butternut, Greenville

Greenville Health System Cancer Institute-Faris, Greenville

Greenville Memorial Hospital, Greenville

29615

Greenville Health System Cancer Institute-Eastside, Greenville

29621

AnMed Health Cancer Center, Anderson

AnMed Health Hospital, Anderson

29640

Greenville Health System Cancer Institute-Easley, Easley

29650

Greenville Health System Cancer Institute-Greer, Greer

29651

Gibbs Cancer Center-Pelham, Greer

29672

Greenville Health System Cancer Institute-Seneca, Seneca

29720

Carolina Blood and Cancer Care Associates PA-Lancaster, Lancaster

29732

Carolina Blood and Cancer Care Associates PA, Rock Hill

30033

Dekalb Medical Center, Decatur

32803

Florida Hospital Orlando, Orlando

34994

Martin Medical Center, Stuart

Robert and Carol Weissman Cancer Center at Martin Health, Stuart

34997

Martin Hospital South, Stuart

36202

Northeast Alabama Regional Medical Center, Anniston

36608

Providence Hospital, Mobile

39581

Singing River Hospital, Pascagoula

40503

Baptist Health Lexington, Lexington

40701

Baptist Health Corbin, Corbin

43015

Delaware Health Center-Grady Cancer Center, Delaware

Delaware Radiation Oncology, Delaware

Grady Memorial Hospital, Delaware

43050

Knox Community Hospital, Mount Vernon

43055

Licking Memorial Hospital, Newark

Newark Radiation Oncology, Newark

43081

Saint Ann's Hospital, Westerville

43130

Fairfield Medical Center, Lancaster

Lancaster Radiation Oncology, Lancaster

43214

Columbus Oncology and Hematology Associates Inc, Columbus

Riverside Methodist Hospital, Columbus

43215

Columbus NCI Community Oncology Research Program, Columbus

Grant Medical Center, Columbus

43219

The Mark H Zangmeister Center, Columbus

43222

Mount Carmel Health Center West, Columbus

43228

Doctors Hospital, Columbus

43701

Genesis Healthcare System Cancer Care Center, Zanesville

45505

Springfield Regional Medical Center, Springfield

45601

Adena Regional Medical Center, Chillicothe

45662

Southern Ohio Medical Center, Portsmouth

45714

Strecker Cancer Center-Belpre, Belpre

45750

Marietta Memorial Hospital, Marietta

46350

IU Health La Porte Hospital, La Porte

46391

Michiana Hematology Oncology PC-Westville, Westville

46514

Michiana Hematology Oncology PC-Elkhart, Elkhart

46515

Elkhart General Hospital, Elkhart

46545

Cancer Care Partners LLC, Mishawaka

Michiana Hematology Oncology PC-Mishawaka, Mishawaka

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka

46563

Michiana Hematology Oncology PC-Plymouth, Plymouth

46601

Memorial Hospital of South Bend, South Bend

Michiana Hematology Oncology PC-South Bend, South Bend

46617

South Bend Clinic, South Bend

46628

Northern Indiana Cancer Research Consortium, South Bend

46904

Community Howard Regional Health, Kokomo

48060

Saint Joseph Mercy Port Huron, Port Huron

48073

William Beaumont Hospital-Royal Oak, Royal Oak

48093

Saint John Macomb-Oakland Hospital, Warren

48098

William Beaumont Hospital - Troy, Troy

48106

Michigan Cancer Research Consortium NCORP, Ann Arbor

48124

Beaumont Hospital-Dearborn, Dearborn

48154

Saint Mary Mercy Hospital, Livonia

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

48236

Saint John Hospital and Medical Center, Detroit

48334

Botsford General Hospital, Farmington

48341

Saint Joseph Mercy Oakland, Pontiac

48439

Genesys Regional Medical Center, Grand Blanc

48502

Hurley Medical Center, Flint

48503

Genesys Hurley Cancer Institute, Flint

48601

Saint Mary's of Michigan, Saginaw

48670

Mid-Michigan Medical Center - Midland, Midland

48912

Sparrow Hospital, Lansing

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49085

Lakeland Hospital, Saint Joseph

Marie Yeager Cancer Center, Saint Joseph

49120

Lakeland Community Hospital, Niles

49201

Allegiance Health, Jackson

51101

Siouxland Regional Cancer Center, Sioux City

51104

Mercy Medical Center-Sioux City, Sioux City

Saint Luke's Regional Medical Center, Sioux City

54017

Cancer Center of Western Wisconsin, New Richmond

55082

Lakeview Hospital, Stillwater

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology and Hematology PA-Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55350

Hutchinson Area Health Care, Hutchinson

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, 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

56073

New Ulm Medical Center, New Ulm

56201

Rice Memorial Hospital, Willmar

58701

Trinity Cancer Care Center, Minot

59101

Billings Clinic Cancer Center, Billings

Montana Cancer Consortium NCORP, Billings

Saint Vincent Healthcare, Billings

59102

Frontier Cancer Center and Blood Institute-Billings, Billings

59405

Benefis Healthcare- Sletten Cancer Institute, 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

59901

Glacier Oncology PLLC, Kalispell

Kalispell Regional Medical Center, Kalispell

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

Ottawa Regional Hospital and Healthcare Center, Ottawa

61354

Illinois CancerCare-Peru, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg Cottage Plaza Office, Galesburg

Illinois CancerCare-Galesburg, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

61462

Holy Family Medical Center, Monmouth

Illinois CancerCare-Monmouth, Monmouth

61520

Illinois CancerCare-Canton, Canton

61530

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

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

61603

Methodist Medical Center of Illinois, Peoria

61614

Proctor Hospital, Peoria

61615

Illinois CancerCare-Peoria, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61701

Saint Joseph Medical Center, Bloomington

61704

Illinois CancerCare-Bloomington, Bloomington

61761

Community Cancer Center Foundation, Normal

Mid-Illinois Hematology Oncology Associates Limited, Normal

62002

Saint Anthony's Health, Alton

62321

Illinois CancerCare-Carthage, Carthage

62401

Crossroads Cancer Center, Effingham

62526

Cancer Care Center of Decatur, Decatur

Decatur Memorial Hospital, Decatur

Heartland Cancer Research NCORP, Decatur

62781

Memorial Medical Center, Springfield

62801

Centralia Oncology Clinic, Centralia

62864

Good Samaritan Regional Health Center, Mount Vernon

62902

Memorial Hospital of Carbondale, Carbondale

63109

Saint Louis Cancer and Breast Institute-South City, St Louis

63141

Mercy Hospital Saint Louis, St Louis

Saint Louis-Cape Girardeau CCOP, St Louis

63703

Saint Francis Medical Center, Cape Girardeau

64057

Centerpoint Medical Center LLC, Independence

64068

Liberty Radiation Oncology Center, Liberty

64086

Saint Luke's East - Lee's Summit, Lee's Summit

64111

Saint Luke's Hospital of Kansas City, Kansas City

64116

North Kansas City Hospital, Kansas City

64118

Heartland Hematology and Oncology Associates Incorporated, Kansas City

64132

Research Medical Center, Kansas City

64506

Heartland Regional Medical Center, Saint Joseph

64507

Saint Joseph Oncology Inc, Saint Joseph

64804

Mercy Hospital-Joplin, Joplin

65401

Phelps County Regional Medical Center, Rolla

Saint John's Clinic-Rolla-Cancer and Hematology, Rolla

65613

Central Care Cancer Center-Carrie J Babb Cancer Center, Bolivar

65804

Cancer Research for the Ozarks NCORP, Springfield

Mercy Hospital Springfield, Springfield

65807

CoxHealth South Hospital, Springfield

66044

Lawrence Memorial Hospital, Lawrence

66112

Providence Medical Center, Kansas City

66208

Kansas City NCI Community Oncology Research Program, Prairie Village

66209

Menorah Medical Center, Overland Park

66213

Saint Luke's South Hospital, Overland Park

66502

Cancer Center of Kansas-Manhattan, Manhattan

66701

Cancer Center of Kansas - Fort Scott, Fort Scott

66720

Cancer Center of Kansas - Chanute, Chanute

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

Cancer Center of Kansas - Wichita, Wichita

Via Christi Regional Medical Center, Wichita

Wichita NCI Community Oncology Research Program, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas - Parsons, Parsons

67401

Cancer Center of Kansas - Salina, Salina

67460

Cancer Center of Kansas - McPherson, McPherson

67801

Cancer Center of Kansas - Dodge City, Dodge City

67905

Cancer Center of Kansas-Liberal, Liberal

68106

Missouri Valley Cancer Consortium, Omaha

68122

Alegent Health Immanuel Medical Center, Omaha

68124

Alegent Health Bergan Mercy Medical Center, Omaha

68130

Alegent Health Lakeside Hospital, Omaha

68131

Creighton University Medical Center, Omaha

68510

Nebraska Cancer Research Center, Lincoln

68847

CHI Health Good Samaritan, Kearney

70112

Tulane University Health Sciences Center, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

70809

Hematology/Oncology Clinic LLP, Baton Rouge

72758

Highlands Oncology Group-Rogers, Rogers

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75246

Baylor University Medical Center, Dallas

77030

M D Anderson Cancer Center, Houston

The Methodist Hospital System, Houston

78041

Doctor's Hospital of Laredo, Laredo

79106

Texas Tech University Health Science Center-Amarillo, Amarillo

80012

The Medical Center of Aurora, Aurora

80033

SCL Health Lutheran Medical Center, Wheat Ridge

80111

Rocky Mountain Cancer Centers-Greenwood Village, Greenwood Village

80113

Comprehensive Cancer Care and Research Institute of Colorado LLC, Englewood

Swedish Medical Center, Englewood

80122

Littleton Adventist Hospital, Littleton

80124

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree

Sky Ridge Medical Center, Lone Tree

80138

Parker Adventist Hospital, Parker

Rocky Mountain Cancer Centers-Parker, Parker

80210

Porter Adventist Hospital, Denver

80218

Colorado Blood Cancer Institute, Denver

Presbyterian - Saint Lukes Medical Center - Health One, Denver

Rocky Mountain Cancer Centers-Midtown, Denver

SCL Health Saint Joseph Hospital, Denver

80220

Rocky Mountain Cancer Centers-Rose, Denver

Rose Medical Center, Denver

80222

Colorado Cancer Research Program NCORP, Denver

80228

Rocky Mountain Cancer Centers-Lakewood, Lakewood

Saint Anthony Hospital, Lakewood

80301

Boulder Community Hospital, Boulder

80304

Rocky Mountain Cancer Centers-Boulder, Boulder

80401

Mountain Blue Cancer Care Center, Golden

80501

Longmont United Hospital, Longmont

Rocky Mountain Cancer Centers-Longmont, Longmont

80524

Poudre Valley Hospital, Fort Collins

80528

Front Range Cancer Specialists, Fort Collins

80539

McKee Medical Center, Loveland

80631

North Colorado Medical Center, Greeley

80907

Penrose-Saint Francis Healthcare, Colorado Springs

Rocky Mountain Cancer Centers-Penrose, Colorado Springs

81004

Saint Mary Corwin Medical Center, Pueblo

81008

Rocky Mountain Cancer Centers - Pueblo, Pueblo

81301

Mercy Medical Center, Durango

82609

Rocky Mountain Oncology, Casper

82801

Welch Cancer Center, Sheridan

83301

Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls

83642

Saint Luke's Mountain States Tumor Institute - Meridian, Meridian

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

83712

Saint Luke's Mountain States Tumor Institute, Boise

83854

Kootenai Cancer Center, Post Falls

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

85719

University of Arizona Cancer Center-North Campus, Tucson

85724

The University of Arizona Medical Center-University Campus, Tucson

87110

Presbyterian Kaseman Hospital, Albuquerque

90033

Los Angeles County-USC Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

90602

Presbyterian Intercommunity Hospital, Whittier

91010

City of Hope Comprehensive Cancer Center, Duarte

91105

Huntington Memorial Hospital, Pasadena

92627

UC Irvine Health Cancer Center-Newport, Costa Mesa

92705

Breastlink Medical Group Inc, Santa Ana

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

94040

El Camino Hospital, Mountain View

94520

John Muir Medical Center-Concord Campus, Concord

94523

East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill, Pleasant Hill

94538

Valley Medical Oncology Consultants-Fremont, Fremont

94546

East Bay Radiation Oncology Center, Castro Valley

Valley Medical Oncology Consultants-Castro Valley, Castro Valley

94568

Epic Care-Dublin, Dublin

94588

Valley Medical Oncology Consultants, Pleasanton

94598

John Muir Medical Center-Walnut Creek, Walnut Creek

94602

Highland General Hospital, Oakland

94608

Bay Area Breast Surgeons Inc, Emeryville

Epic Care Partners in Cancer Care, 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

96701

Oncare Hawaii Inc-Pali Momi, ‘Aiea

Pali Momi Medical Center, ‘Aiea

96734

Castle Medical Center, Kailua

96766

Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue

96813

Hawaii Cancer Care Inc-POB II, Honolulu

Queen's Medical Center, Honolulu

Straub Clinic and Hospital, Honolulu

University of Hawaii Cancer Center, Honolulu

96817

Hawaii Cancer Care Inc-Liliha, Honolulu

Hawaii Oncology Inc-Kuakini, Honolulu

Kuakini Medical Center, Honolulu

96826

Kapiolani Medical Center for Women and Children, Honolulu

97015

Clackamas Radiation Oncology Center, Clackamas

97030

Legacy Mount Hood Medical Center, Gresham

97045

Providence Willamette Falls Medical Center, Oregon City

97062

Legacy Meridian Park Hospital, Tualatin

97132

Providence Newberg Medical Center, Newberg

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

97213

Providence Portland Medical Center, Portland

Western Oncology Research Consortium, Portland

97222

Providence Milwaukie Hospital, Milwaukie

97225

Providence Saint Vincent Medical Center, Portland

97227

Legacy Emanuel Hospital and Health Center, Portland

98033

EvergreenHealth Medical Center, Kirkland

98101

Virginia Mason CCOP, Seattle

98104

Pacific Medical Center-First Hill, Seattle

98664

PeaceHealth Southwest Medical Center, Vancouver

98684

Compass Oncology Vancouver, Vancouver

98686

Legacy Salmon Creek Hospital, Vancouver

99220

Rockwood Clinic, Spokane

99508

Alaska Breast Care and Surgery LLC, Anchorage

Alaska Regional Hospital, Anchorage

Alaska Women's Cancer Care, Anchorage

Anchorage Oncology Centre, Anchorage

Katmai Oncology Group, Anchorage

Providence Alaska Medical Center, Anchorage

99701

Fairbanks Memorial Hospital, Fairbanks

94553-3156

Contra Costa Regional Medical Center, Martinez

06830

Greenwich Hospital, Greenwich

06105

Smilow Cancer Hospital Care Center at Saint Francis, Hartford

06457

Middlesex Hospital, Middletown

46514-2098

Elkhart Clinic, Elkhart

02135

Steward Saint Elizabeth's Medical Center, Brighton

01805

Lahey Hospital and Medical Center, Burlington

48106-0995

Saint Joseph Mercy Hospital, Ann Arbor

08360

Inspira Medical Center Vineland, Vineland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

SWOG Cancer Research Network

NETWORK

NCT01097278 - S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer | Biotech Hunter | Biotech Hunter