Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01097278
First received: March 31, 2010
Last updated: January 7, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
brca1 Mutation Carrier
brca2 Mutation Carrier
Breast Cancer
Dietary Supplement: cholecalciferol
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Change in mammographic density at 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: cholecalciferol
Given orally
Other: placebo
Given orally

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097278

  Hide Study Locations
Locations
United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36202
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Regional Hospital
Anchorage, Alaska, United States, 99508
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Highlands Oncology Group-Rogers
Rogers, Arkansas, United States, 72758
United States, California
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
UC Irvine Health Pacific Breast Care Center
Costa Mesa, California, United States, 92627
City of Hope
Duarte, California, United States, 91010
Epic Care-Dublin
Dublin, California, United States, 94568
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Breastlink Medical Group Inc
Long Beach, California, United States, 90806
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
University of Southern California
Los Angeles, California, United States, 90033
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
El Camino Hospital
Mountain View, California, United States, 94040
Bay Area Tumor Institute CCOP
Oakland, California, United States, 94609
Bay Area Breast Surgeons Inc
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Epic Care-Oakland
Oakland, California, United States, 94612
Highland General Hospital
Oakland, California, United States, 94602
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
Huntington Memorial Hospital
Pasadena, California, United States, 91105
East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
Pleasant Hill, California, United States, 94523
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
John Muir Medical Center
Walnut Creek, California, United States, 94598
Presbyterian Intercommunity Hospital
Whittier, California, United States, 90602
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States, 80909
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Mercy Medical Center
Durango, Colorado, United States, 81301
Swedish Medical Center
Englewood, Colorado, United States, 80113
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Middlesex Hospital
Middletown, Connecticut, United States, 06457
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Martin Hospital South
Stuart, Florida, United States, 34997
Martin Medical Center
Stuart, Florida, United States, 34994
Robert and Carol Weissman Cancer Center at Martin Health
Stuart, Florida, United States, 34994
United States, Georgia
Dekalb Medical Center
Decatur, Georgia, United States, 30033
United States, Hawaii
Oncare Hawaii Inc-Pali Momi
Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
University of Hawaii
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Saint Anthony's Health
Alton, Illinois, United States, 62002
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Galesburg Cottage Plaza Office
Galesburg, Illinois, United States, 61401
Delnor Community Hospital
Geneva, Illinois, United States, 60134
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Mid-Illinois Hematology Oncology Associates
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Central DuPage Hospital Cancer Center
Warrenville, Illinois, United States, 60555
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital
La Porte, Indiana, United States, 46350
Cancer Care Partners LLC
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Providence Medical Center
Kansas City, Kansas, United States, 66112
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Louisiana
Hematology/Oncology Clinic LLP
Baton Rouge, Louisiana, United States, 70809
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Caritas Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135-2997
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Wayne State University-Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Botsford General Hospital
Farmington, Michigan, United States, 48334
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mid-Michigan Medical Center - Midland
Midland, Michigan, United States, 48670
Lakeland Cancer Specialists
Niles, Michigan, United States, 49102
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Providence Hospital
Southfield, Michigan, United States, 48075
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States, 65613
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Mercy Hospital-Joplin
Joplin, Missouri, United States, 64804
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Clinic
Liberty, Missouri, United States, 64068
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States, 68106
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, New Hampshire
Saint Joseph Hospital
Nashua, New Hampshire, United States, 03060
United States, New Mexico
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
United States, New York
Hematology Oncology Associates of Central New York PC-East Syracuse
East Syracuse, New York, United States, 13057
Winthrop University Hospital
Mineola, New York, United States, 11501
Columbia University Medical Center
New York, New York, United States, 10032
Highland Hospital
Rochester, New York, United States, 14620
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States, 28792
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States, 27320
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Doctors Hospital
Columbus, Ohio, United States, 43228
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Grant Medical Center
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Columbus CCOP
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Summa Health Center at Lake Medina
Medina, Ohio, United States, 44256
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Western Oncology Research Consortium
Portland, Oregon, United States, 97213
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Instutite/Greenville CCOP
Greenville, South Carolina, United States, 29615
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Carolina Blood and Cancer Care Associates PA-Lancaster
Lancaster, South Carolina, United States, 29720
Carolina Blood and Cancer Care Associates PA
Rock Hill, South Carolina, United States, 29732
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, Texas
Texas Tech University Health Science Center-Amarillo
Amarillo, Texas, United States, 79106
Baylor University Medical Center
Dallas, Texas, United States, 75246
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98033
Pacific Medical Center-First Hill
Seattle, Washington, United States, 98104
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Rockwood Clinic
Spokane, Washington, United States, 99220
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
Compass Oncology Vancouver
Vancouver, Washington, United States, 98684
United States, West Virginia
Princeton Community Hospital
Princeton, West Virginia, United States, 24740
United States, Wisconsin
Mercy Health System
Janesville, Wisconsin, United States, 53547
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Katherine D. Crew, MD, MS Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01097278     History of Changes
Other Study ID Numbers: S0812, S0812, U10CA037429, NCI-2011-02032
Study First Received: March 31, 2010
Last Updated: January 7, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
BRCA1 mutation carrier
BRCA2 mutation carrier

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cholecalciferol
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on March 03, 2015