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

November 21, 2017 updated by: Southwest Oncology Group

Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer

RATIONALE: Cholecalciferol may prevent breast cancer in premenopausal women.

PURPOSE: This randomized phase II trial is studying how well cholecalciferol works in preventing breast cancer in premenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

To assess whether mammographic density is reduced in premenopausal women at high risk of breast cancer taking high-dose vitamin D3 (oral cholecalciferol 20,000 IU weekly) vs placebo for 1 year.
To assess whether proliferation as measured by Ki-67 staining of breast epithelial cells is reduced in women receiving these treatments.
To explore the difference in the expression of other biomarkers (including cleaved caspase-3 [apoptosis marker], ER, vitamin D receptor [VDR], and 1α-hydroxylase) in breast tissue obtained from these women.
To assess whether parathyroid hormone, IGF-1, IGFBP-3, 25(OH)D, and 1,25(OH)D serum levels are altered in these women at baseline and at 6 and 12 months.
To explore whether a change in mammographic density correlates with polymorphisms in the VDR gene.
To assess other sources of vitamin D (sunlight exposure, diet) in these women using a validated questionnaire administered at baseline and at 12 and 24 months.
To collect and bank serum, plasma, and breast tissue from these women before and after a 1-year intervention with vitamin D for future biomarker analysis.
To assess the toxicity of high-dose cholecalciferol compared to placebo in this setting.

OUTLINE: This is a multicenter study. Participants are stratified according to baseline serum 25(OH)D level (< 20 ng/mL vs 20-32 ng/mL or < 50 nmol/L vs 50-80 nmol/L), baseline mammographic density (11-50% vs > 50%), and designated biopsy site (yes vs no). Participants are randomized to 1 of 2 treatment arms.

Arm I: Participants receive oral cholecalciferol once weekly and oral vitamin D once daily. Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity.
Arm II: Participants receive oral placebo once weekly and oral vitamin D once daily. Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity.

Blood samples are collected at baseline and periodically thereafter for biomarkers and 25(OH)D level. Participants undergo a mammogram at baseline and at 12 months. Participants may also undergo random core-needle breast biopsy at baseline and at 12 months.

Participants complete a questionnaire at baseline and at 12 and 24 months.

After completion of study therapy, participants are followed up at 1 and 12 months.

Study Type

Interventional

Enrollment (Actual)

208

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Anniston, Alabama, United States, 36202
    - Northeast Alabama Regional Medical Center
  - Mobile, Alabama, United States, 36608
    - Providence Hospital
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, United States, 99508
    - Alaska Regional Hospital
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Memorial Hospital
- Arizona
  - Tucson, Arizona, United States, 85719
    - University of Arizona Cancer Center-North Campus
  - Tucson, Arizona, United States, 85724
    - The University of Arizona Medical Center-University Campus
- Arkansas
  - Rogers, Arkansas, United States, 72758
    - Highlands Oncology Group-Rogers
- California
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants-Castro Valley
  - Concord, California, United States, 94520
    - John Muir Medical Center-Concord Campus
  - Costa Mesa, California, United States, 92627
    - UC Irvine Health Cancer Center-Newport
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Dublin, California, United States, 94568
    - Epic Care-Dublin
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Emeryville, California, United States, 94608
    - Epic Care Partners in Cancer Care
  - Fremont, California, United States, 94538
    - Valley Medical Oncology Consultants-Fremont
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Tom K Lee Inc
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Pasadena, California, United States, 91105
    - Huntington Memorial Hospital
  - Pleasant Hill, California, United States, 94523
    - East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - Santa Ana, California, United States, 92705
    - Breastlink Medical Group Inc
  - Walnut Creek, California, United States, 94598
    - John Muir Medical Center-Walnut Creek
  - Whittier, California, United States, 90602
    - Presbyterian Intercommunity Hospital
- Colorado
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80222
    - Colorado Cancer Research Program NCORP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Englewood, Colorado, United States, 80113
    - Comprehensive Cancer Care and Research Institute of Colorado LLC
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Rocky Mountain Cancer Centers-Greenwood Village
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Greenwich, Connecticut, United States, 06830
    - Greenwich Hospital
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
- Florida
  - Orlando, Florida, United States, 32803
    - Florida Hospital Orlando
  - Stuart, Florida, United States, 34994
    - Martin Medical Center
  - Stuart, Florida, United States, 34994
    - Robert and Carol Weissman Cancer Center at Martin Health
  - Stuart, Florida, United States, 34997
    - Martin Hospital South
- Georgia
  - Decatur, Georgia, United States, 30033
    - Dekalb Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Oncare Hawaii Inc-Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc-POB II
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Oncology Inc-Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Mountain States Tumor Institute
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Mountain States Tumor Institute - Meridian
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Mountain States Tumor Institute-Twin Falls
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Health
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Heartland Cancer Research NCORP
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg Cottage Plaza Office
  - Geneva, Illinois, United States, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Monmouth, Illinois, United States, 61462
    - Holy Family Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Normal, Illinois, United States, 61761
    - Mid-Illinois Hematology Oncology Associates Limited
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61603
    - Methodist Medical Center of Illinois
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Cancer Care Partners LLC
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Prairie Village, Kansas, United States, 66208
    - Kansas City NCI Community Oncology Research Program
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Wichita NCI Community Oncology Research Program
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Corbin, Kentucky, United States, 40701
    - Baptist Health Corbin
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Hematology/Oncology Clinic LLP
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
- Massachusetts
  - Brighton, Massachusetts, United States, 02135
    - Steward Saint Elizabeth's Medical Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital-Dearborn
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Farmington, Michigan, United States, 48334
    - Botsford General Hospital
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Blanc, Michigan, United States, 48439
    - Genesys Regional Medical Center
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Midland, Michigan, United States, 48670
    - Mid-Michigan Medical Center - Midland
  - Niles, Michigan, United States, 49120
    - Lakeland Community Hospital
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Troy, Michigan, United States, 48098
    - William Beaumont Hospital - Troy
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Mississippi
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center-Carrie J Babb Cancer Center
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital-Joplin
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Phelps County Regional Medical Center
  - Rolla, Missouri, United States, 65401
    - Saint John's Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology Inc
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint Louis-Cape Girardeau CCOP
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Frontier Cancer Center and Blood Institute-Billings
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium NCORP
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology PLLC
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
- New Jersey
  - Vineland, New Jersey, United States, 08360
    - Inspira Medical Center Vineland
- New Mexico
  - Albuquerque, New Mexico, United States, 87110
    - Presbyterian Kaseman Hospital
- New York
  - Auburn, New York, United States, 13021
    - Hematology Oncology Associates of Central New York-Auburn
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New York, New York, United States, 10032
    - Columbia University/Herbert Irving Cancer Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rochester, New York, United States, 14620
    - Highland Hospital
  - Rome, New York, United States, 13440
    - Hematology Oncology Associates of Central New York-Rome
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - Syracuse, New York, United States, 13215
    - Hematology Oncology Associates of Central New York-Onondaga Hill
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Presbyterian Medical Center
  - Charlotte, North Carolina, United States, 28262
    - Southern Oncology Specialists-Charlotte
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Hendersonville, North Carolina, United States, 28791
    - Hendersonville Hematology and Oncology at Pardee
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Hendersonville, North Carolina, United States, 28792
    - Park Ridge Hospital Breast Health Center
  - Huntersville, North Carolina, United States, 28078
    - Southern Oncology Specialists-Huntersville
  - Matthews, North Carolina, United States, 28105
    - Novant Health Cancer Specialists-Matthews
  - Mooresville, North Carolina, United States, 28117
    - Lake Norman Hematology Oncology Specialists-Mooresville
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Cancer Care Center
- Ohio
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital and Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Legacy Emanuel Hospital and Health Center
  - Portland, Oregon, United States, 97213
    - Western Oncology Research Consortium
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Phoenixville, Pennsylvania, United States, 19460
    - Phoenixville Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Hospital
  - Easley, South Carolina, United States, 29640
    - Greenville Health System Cancer Institute-Easley
  - Florence, South Carolina, United States, 29506
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Andrews
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Faris
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute-Eastside
  - Greenville, South Carolina, United States, 29605
    - Greenville Health System Cancer Institute-Butternut
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Greer, South Carolina, United States, 29650
    - Greenville Health System Cancer Institute-Greer
  - Lancaster, South Carolina, United States, 29720
    - Carolina Blood and Cancer Care Associates PA-Lancaster
  - Rock Hill, South Carolina, United States, 29732
    - Carolina Blood and Cancer Care Associates PA
  - Seneca, South Carolina, United States, 29672
    - Greenville Health System Cancer Institute-Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Greenville Health System Cancer Institute-Spartanburg
- Texas
  - Amarillo, Texas, United States, 79106
    - Texas Tech University Health Science Center-Amarillo
  - Dallas, Texas, United States, 75246
    - Baylor University Medical Center
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
  - Houston, Texas, United States, 77030
    - The Methodist Hospital System
  - Laredo, Texas, United States, 78041
    - Doctor's Hospital of Laredo
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
- Washington
  - Kirkland, Washington, United States, 98033
    - EvergreenHealth Medical Center
  - Seattle, Washington, United States, 98104
    - Pacific Medical Center-First Hill
  - Seattle, Washington, United States, 98101
    - Virginia Mason CCOP
  - Spokane, Washington, United States, 99220
    - Rockwood Clinic
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Hospital
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
- West Virginia
  - Princeton, West Virginia, United States, 24740
    - Princeton Community Hospital
- Wisconsin
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

At an elevated risk of breast cancer by at least one of the following criteria:
- Diagnosis of ADH, ALH, lobular carcinoma in situ (LCIS) or resected ductal carcinoma in situ (DCIS) or small invasive breast cancers (pTmi or pT1a N0) if no pior RT, tamoxifen, or systemic breast cancer treatment within 28 days prior to registration OR diagnosis of resected Stage I (T1b-c N0-N1mi) through Stage II breast cancer for which the participant has been disease-free for at least 5 years and has completed all adjuvant treatment OR
- A known* deleterious mutation in BRCA1, BRCA2, PTEN, or TP53 NOTE: *The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per NCCN clinical guidelines to be eligible per this criterion.
- Modified Gail Model/CARE model** risk at 5 years ≥ 1.67% or lifetime risk ≥ 20% by Claus, BRCAPro, Tyrer-Cuzick or IBIS models OR
- Mammographic density ≥ 50% (heterogenously dense) NOTE: **Risk models are to be used only if there is no known previous diagnosis of resected DCIS or LCIS and there is no known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53.
At least one breast available for imaging and biopsy (a previously irradiated breast [i.e., for resected DCIS] is not evaluable for breast imaging or biopsy)
Baseline mammogram (performed within 10 days after starting their last menstrual period on a digital mammography machine) that shows either normal or benign findings
- Baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, "heterogeneously dense"; 4 = >75, "extremely dense". Women with a baseline mammographic density of ≤ 10% (1 = ≤ 10% breasts are almost entirely fat)will not be eligible.

PATIENT CHARACTERISTICS:

Premenopausal, defined as ≥ 1 of the following criteria:
- Less than 6 months since the last menstrual period, no prior bilateral oophorectomy, and no use of hormone-replacement therapy
- Has undergone a prior hysterectomy but no prior bilateral oophorectomy AND follicle-stimulating hormone values measured within the past 28 days are consistent with the normal values for the premenopausal state
Zubrod performance status 0-1
Serum creatinine ≤ upper limit of normal (ULN)
Serum calcium or corrected calcium ≤ ULN
Spot urine calcium:creatinine ratio < 0.37 mg/dL
INR ≤ 1.5 times ULN+
PT and PTT ≤ ULN*
Baseline serum 25(OH)D level ≤ 32 ng/mL (or 80 nmol/L)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other prior malignancy except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II (including resected Stage I, T1b-c N0-N1mi through Stage II breast cancer) from which the participant is currently in complete remission
- Any other cancer (including contralateral breast) for which the participant has been disease-free for ≥ 5 years
No history of kidney stones
No medical conditions requiring calcium or vitamin D supplementation (i.e., osteoporosis)
No known hypersensitivity to vitamin D
No known allergy to soy NOTE: +For patients undergoing breast biopsy.

PRIOR CONCURRENT THERAPY:

Prior breast reduction surgery allowed
- No bilateral breast implants
More than 1 month since prior surgery or radiotherapy to the breast for resected DCIS
At least 28 days since prior tamoxifen
Prior anticoagulant therapy allowed provided it is discontinued ≥ 7 days before breast biopsy
No concurrent calcium or additional vitamin D supplements
- Concurrent multivitamins allowed provided that the dose of vitamin D in the multivitamin does not exceed 400 IU daily
No concurrent participation in any other clinical trial for the treatment or prevention of cancer unless the participant is no longer receiving the intervention and is in the follow-up phase only (participants must not join such a trial while participating in this study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I Participants receive oral cholecalciferol once weekly and oral vitamin D once daily. Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity.	Dietary supplement: cholecalciferol Given orally
ACTIVE_COMPARATOR: Arm II Participants receive oral placebo once weekly and oral vitamin D once daily. Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity.	Other: placebo Given orally Dietary supplement: cholecalciferol Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mammographic density at 12 months compared to baseline Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Katherine D. Crew, MD, MS, Columbia University

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 Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

March 31, 2010

First Posted (ESTIMATE)

April 1, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

S0812 (OTHER: SWOG)
U10CA037429 (U.S. NIH Grant/Contract)
NCI-2011-02032 (OTHER: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Cancer

Clinical Trials on placebo

Search Similar Trials

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