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brca1 Mutation CarrierNCT01097278

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

A study testing cholecalciferol in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by SWOG Cancer Research Network at 360 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
208 participants
Where
360 sitesUnited States
Study dates
1 Nov 2011to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

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)

Trial locations and contacts

360 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Oncare Hawaii Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Texas Tech University Health Science Center-Amarillo

    Amarillo, Texas, 79106

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36202

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Hematology/Oncology Clinic LLP

    Baton Rouge, Louisiana, 70809

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Central Care Cancer Center-Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Steward Saint Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • UC Irvine Health Cancer Center-Newport

    Costa Mesa, California, 92627

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program NCORP

    Denver, Colorado, 80222

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Epic Care-Dublin

    Dublin, California, 94568

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Botsford General Hospital

    Farmington, Michigan, 48334

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Illinois CancerCare-Galesburg Cottage Plaza Office

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hendersonville Hematology and Oncology at Pardee

    Hendersonville, North Carolina, 28791

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Park Ridge Hospital Breast Health Center

    Hendersonville, North Carolina, 28792

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Oncology Inc-Kuakini

    Honolulu, Hawaii, 96817

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • The Methodist Hospital System

    Houston, Texas, 77030

  • Southern Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Allegiance Health

    Jackson, Michigan, 49201

  • Mercy Hospital-Joplin

    Joplin, Missouri, 64804

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • EvergreenHealth Medical Center

    Kirkland, Washington, 98033

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster Radiation Oncology

    Lancaster, Ohio, 43130

  • Carolina Blood and Cancer Care Associates PA-Lancaster

    Lancaster, South Carolina, 29720

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Novant Health Cancer Specialists-Matthews

    Matthews, North Carolina, 28105

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Saint Luke's Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • Mid-Michigan Medical Center - Midland

    Midland, Michigan, 48670

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Cancer Care Partners LLC

    Mishawaka, Indiana, 46545

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Providence Hospital

    Mobile, Alabama, 36608

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Lake Norman Hematology Oncology Specialists-Mooresville

    Mooresville, North Carolina, 28117

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • El Camino Hospital

    Mountain View, California, 94040

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Columbia University/Herbert Irving Cancer Center

    New York, New York, 10032

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Lakeland Community Hospital

    Niles, Michigan, 49120

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Mid-Illinois Hematology Oncology Associates Limited

    Normal, Illinois, 61761

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Rocky Mountain Cancer Centers-Parker

    Parker, Colorado, 80138

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Huntington Memorial Hospital

    Pasadena, California, 91105

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460

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

    Pleasant Hill, California, 94523

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Western Oncology Research Consortium

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Princeton Community Hospital

    Princeton, West Virginia, 24740

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rocky Mountain Cancer Centers - Pueblo

    Pueblo, Colorado, 81008

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Carolina Blood and Cancer Care Associates PA

    Rock Hill, South Carolina, 29732

  • Highlands Oncology Group-Rogers

    Rogers, Arkansas, 72758

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

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

    Rolla, Missouri, 65401

  • Hematology Oncology Associates of Central New York-Rome

    Rome, New York, 13440

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
cholecalciferol, placebo
Keywords
breast cancer, ductal breast carcinoma in situ, lobular breast carcinoma in situ, BRCA1 mutation carrier, BRCA2 mutation carrier
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01097278
Study groupRoleWhat they receive
Arm IExperimentalParticipants 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.
Receives: Dietary Supplement: cholecalciferol
Arm IIActive comparatorParticipants 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.
Receives: Dietary Supplement: cholecalciferol; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mammographic density at 12 months compared to baseline

    Measured: 12 months

Secondary outcomes (1)

  1. Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2010 (estimated)
  2. Study start1 Nov 2011
  3. Primary completionAug 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Phase 2 study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01097278
Sponsor's protocol ID
S0812
Other IDs
S0812, U10CA037429, NCI-2011-02032
Status last verified
Nov 2017
First submitted
31 Mar 2010
Last updated
24 Nov 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing cholecalciferol in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by SWOG Cancer Research Network at 360 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 360 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mammographic density at 12 months compared to baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01097278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.

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