In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

  • First Published: 3/30/2010
  • Last Modified: 10/4/2012

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Popular Resources

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

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of High-Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, PreventionActive18 to 50NCISWOG-S0812
S0812, NCT01097278

Trial Description

Purpose:

Cholecalciferol may prevent breast cancer in premenopausal women.

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

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly (have an equal chance of being placed) to 1 of 2 treatment groups.

Patients in group one will receive cholecalciferol by mouth once a week and vitamin D by mouth once a day. Treatment may continue for 12 months.

Patients in group two will receive placebo by mouth once a week and vitamin D by mouth once a day. Treatment may continue for 12 months.

Patients may undergo blood and tissue sample collection periodically for laboratory studies.

Patients may complete a questionnaire at the beginning of treatment and at 12 and 24 months.

After finishing treatment, patients will be evaluated at 1 and 12 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Laurence Baker, DO, FACOI, Principal investigator
Ph: 734-998-7130

Trial Sites

U.S.A.
Alabama
  Anniston
 Regional Medical Center
 George Crawford, Jr.
Ph: 256-235-5877
Alaska
  Anchorage
 Alaska Regional Hospital Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
Arizona
  Tucson
 Arizona Cancer Center at University Medical Center North
 Joanne Jeter
Ph: 520-694-2873
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center
Ph: 520-626-9008
California
  Duarte
 City of Hope Comprehensive Cancer Center
 Clinical Trials Office - City of Hope Comprehensive Cancer Center
Ph: 800-826-4673
  Email: becomingapatient@coh.org
  Martinez
 Contra Costa Regional Medical Center
 James Feusner, MD
Ph: 510-428-3689
  Mountain View
 El Camino Hospital Cancer Center
 Clinical Trials Office - El Camino Hospital Cancer Center
Ph: 650-988-7623
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus
Ph: 510-204-1414
 CCOP - Bay Area Tumor Institute
 James Feusner, MD
Ph: 510-428-3689
 Epic Care - Oakland
 James Feusner, MD
Ph: 510-428-3689
 Highland General Hospital
 James Feusner, MD
Ph: 510-428-3689
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Clinical Trials Office - Chao Family Comprehensive Cancer Center
Ph: 877-UC-STUDY
  Email: ucstudy@uci.edu
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James Feusner, MD
Ph: 510-428-3689
Colorado
  Fort Collins
 Front Range Cancer Specialists
 Robert Marschke, Jr.
Ph: 970-212-7600
 Poudre Valley Hospital
 Clinical Trials Office - Poudre Valley Hospital
Ph: 970-495-8226
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip Stella, MD
Ph: 734-712-1000
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Oncare Hawaii, Incorporated - Pali Momi
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Honolulu
 Cancer Research Center of Hawaii
 Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979
 Kapiolani Medical Center for Women and Children
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Kuakini Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Straub Clinic and Hospital, Incorporated
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Tripler Army Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Kailua
 Castle Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Lihue
 Kauai Medical Clinic
 Jeffrey Berenberg, MD
Ph: 808-433-4089
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Paul Montgomery, MD
Ph: 208-381-2711
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Clinical Trials Office - Saint Alphonsus Cancer Care Center
Ph: 208-367-7954
  Meridian
 Mountain States Tumor Institute - Meridian
 Paul Montgomery, MD
Ph: 208-381-2711
  Twin Falls
 Mountain States Tumor Institute at St. Luke's
 Paul Montgomery, MD
Ph: 208-381-2711
Illinois
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-4750
  Geneva
 Delnor Hospital - Geneva
 Robert Bayer, MD
Ph: 630-232-0610
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
  Mount Vernon
 Good Samaritan Regional Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Normal
 Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
 John Migas, MD
Ph: 309-451-2207
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
  Warrenville
 Central Dupage Cancer Center
 John Ayers
Ph: 630-933-1600
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Kentucky
  Lexington
 Central Baptist Hospital
 Clinical Trials Office - Central Baptist Hospital
Ph: 859-260-6425
Louisiana
  Shreveport
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Ph: 318-813-1412
Massachusetts
  Brighton
 Caritas St. Elizabeth's Medical Center
 Dorcas Chi
Ph: 617-789-3000
  Burlington
 Lahey Clinic Medical Center - Burlington
 Clinical Trials Office - Lahey Clinic Medical Center - Burlington
Ph: 781-744-8027
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Chapman, MD
Ph: 313-916-1332
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Jackson
 Foote Memorial Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus
Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Mississippi
  Pascagoula
 Regional Cancer Center at Singing River Hospital
 James Clarkson, MD
Ph: 228-374-6296
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Robert Carolla
Ph: 417-326-7200
800-592-5110
  Cape Girardeau
 Saint Francis Medical Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Robert Carolla
Ph: 573-458-6379
 Phelps County Regional Medical Center
 Robert Carolla
Ph: 573-458-8899
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany Sleckman, MD
Ph: 314-251-7057
 David C. Pratt Cancer Center at St. John's Mercy
 Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy
Ph: 314-251-6770
 Midwest Hematology Oncology Group, Incorporated
 Bethany Sleckman, MD
Ph: 314-251-7057
  Springfield
 CCOP - Cancer Research for the Ozarks
 Robert Carolla
Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert Carolla
Ph: 417-269-5257
 St. John's Regional Health Center
 Robert Carolla
Ph: 417-820-2000
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
  Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
 St. Vincent Healthcare Cancer Care Services
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
 Sletten Cancer Institute at Benefis Healthcare
 Grant Harrer, MD, FACP, CCTI
Ph: 406-731-8100
  Helena
 St. Peter's Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
  Kalispell
 Glacier Oncology, PLLC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Regional Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Ph: 406-329-7029
 Montana Cancer Specialists at Montana Cancer Center
 Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center
Ph: 406-238-6962
Nebraska
  Kearney
 Good Samaritan Cancer Center at Good Samaritan Hospital
 Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital
Ph: 308-865-7963
New Mexico
  Albuquerque
 Lovelace Medical Center - Downtown
 Melanie Royce, MD, PhD
Ph: 505-272-6057
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Elmira
 Falck Cancer Center at Arnot Ogden Medical Center
 Clinical Trials Office - Falck Cancer Center at Arnot Ogden Medical Center
Ph: 607-271-7000
  Mineola
 Winthrop University Hospital
 Nina D'Abreo
Ph: 516-663-9500
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615
  Rochester
 Highland Hospital of Rochester
 Jonathan Friedberg
Ph: 585-473-2200
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan Friedberg
Ph: 585-275-5345
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther Rehmus, MD
Ph: 330-344-6505
  Chillicothe
 Adena Regional Medical Center
 Clinical Trials Office - Adena Regional Medical Center
Ph: 877-779-7585
  Columbus
 CCOP - Columbus
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
 Doctors Hospital at Ohio Health
 Clinical Trials Office - Doctors Hospital at Ohio Health
Ph: 614-566-3275
 Grant Medical Center Cancer Care
 Clinical Trials Office - Grant Medical Center Cancer Care
Ph: 614-566-4475
 Mount Carmel Health - West Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
 Riverside Methodist Hospital Cancer Care
 Clinical Trials Office - Riverside Methodist Hospital Cancer Care
Ph: 614-566-4475
  Delaware
 Grady Memorial Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Zanesville
 Genesis - Good Samaritan Hospital
 Clinical Trials Office - Genesis - Good Samaritan Hospital
Ph: 740-454-5232
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison Conlin
Ph: 503-513-3300
  Gresham
 Legacy Mount Hood Medical Center
 Clinical Trials Office - Legacy Mount Hood Medical Center
Ph: 503-413-2150
  Milwaukie
 Providence Milwaukie Hospital
 Alison Conlin
Ph: 503-513-8300
  Newberg
 Providence Newberg Medical Center
 Alison Conlin
Ph: 503-537-1555
  Oregon City
 Willamette Falls Hospital
 Alison Conlin
Ph: 503-650-6758
  Portland
 CCOP - Columbia River Oncology Program
 Alison Conlin
Ph: 503-216-6260
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital
Ph: 503-413-8199
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Ph: 503-413-1742
 Providence Cancer Center at Providence Portland Medical Center
 Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center
Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Clinical Trials Office - Providence St. Vincent Medical Center
Ph: 503-215-6412
  Tualatin
 Legacy Meridian Park Hospital
 Clinical Trials Office - Legacy Meridian Park Hospital
Ph: 503-413-1742
South Carolina
  Anderson
 AnMed Cancer Center
 Clinical Trials Office - AnMed Cancer Center
Ph: 864-512-1000
  Easley
 Cancer Centers of the Carolinas - Easley
 Clinical Trials Office - Cancer Centers of the Carolinas
Ph: 864-241-6251
  Greenville
 Bon Secours St. Francis Health System
 Clinical Trails Office - Bon Secours St. Francis Health System
Ph: 864-255-1713
 Cancer Centers of the Carolinas - Eastside
 Clinical Trials Office - Cancer Centers of the Carolinas
Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
 Cancer Centers of the Carolinas - Grove Commons
 Clinical Trials Office - Cancer Centers of the Carolinas
Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Greer
 Cancer Centers of the Carolinas - Greer Medical Oncology
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Rock Hill
 Carolina Blood and Cancer Care
 James Bearden, MD
Ph: 864-560-6812
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
 CCOP - Upstate Carolina
 Clinical Trials Office - CCOP - Upstate Carolina
Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Clinical Trials Office - Gibbs Regional Cancer Center
Ph: 800-486-5941
Texas
  Houston
 Methodist Hospital
 Angel Rodriguez
Ph: 713-441-1010
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Clinical Trials Office - Huntsman Cancer Institute at University of Utah
Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Washington
  Vancouver
 Legacy Salmon Creek Medical Center
 Jacqueline Vuky
Ph: 360-487-1000
 Southwest Washington Medical Center Cancer Center
 Alison Conlin
Ph: 360-514-2174
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Marchello, MD
Ph: 406-238-6290

Registry Information
Official Title Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer
Trial Start Date 2011-11-01
Trial Completion Date 2014-05-01 (estimated)
Registered in ClinicalTrials.gov NCT01097278
Date Submitted to PDQ 2010-03-23
Information Last Verified 2012-10-04
NCI Grant/Contract Number CA37429

Back to TopBack to Top