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

Alternate Title

Randomized Study of Vitamin D and Breast Cancer Biomarkers in Female Patients

Basic Trial Information

Trial Description

Purpose:

Vitamin D may help prevent breast cancer.

This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.

Eligibility:

Eligibility criteria include the following:

• 55 years old and younger
• Breast density ≥ 25%
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

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

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive placebo by mouth once a day for 1 year.

Patients in group two will receive vitamin D by mouth once a day for 1 year.

Blood and tissue samples may be collected at the beginning of treatment and at 1 year for laboratory studies. Patients also complete questionnaires at the beginning of treatment and at 1 year.

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

Cancer and Leukemia Group B

Marie Wood, MD, Protocol chair		Ph: 802-656-5452

U.S.A.
Alabama
	Anniston
	Regional Medical Center
		George Crawford, Jr.	Ph:  256-235-5877
California
	Martinez
	Contra Costa Regional Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Mountain View
	Camino Medical Group - Treatment Center
		Peter Yu, MD	Ph:  408-524-5814
	El Camino Hospital Cancer Center
		Clinical Trials Office - El Camino Hospital Cancer Center	Ph:  650-988-7623
	Oakland
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Palo Alto
	Palo Alto Medical Foundation
		David Leibowitz	Ph:  650-321-4121
	Pismo Beach
		David Palchak, MD	Ph:  805-773-7127
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
Connecticut
	Greenwich
	Bendheim Cancer Center at Greenwich Hospital
		Clinical Trials Office - Bendheim Cancer Center	Ph:  203-863-3698
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Michael Schwartz, MD	Ph:  305-535-3310
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
Illinois
	Bloomington
	St. Joseph Medical Center
		Nguyet Le-Lindqwister	Ph:  309-662-3311
	Bloomington%
	Illinois CancerCare - Bloomington
		Nguyet Le-Lindqwister	Ph:  309-662-2102
	Canton
	Graham Hospital
		Nguyet Le-Lindqwister	Ph:  309-647-5240
	Illinois CancerCare - Canton
		Nguyet Le-Lindqwister	Ph:  309-647-5240
	Carthage
	Memorial Hospital
		Nguyet Le-Lindqwister	Ph:  217-357-3131
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Eureka
	Eureka Community Hospital
		Nguyet Le-Lindqwister	Ph:  309-467-2371
	Illinois CancerCare - Eureka
		Nguyet Le-Lindqwister	Ph:  309-467-2371
	Galesburg
	Galesburg Clinic, PC
		Nguyet Le-Lindqwister	Ph:  309-344-1000
	Illinois CancerCare - Galesburg
		Nguyet Le-Lindqwister	Ph:  309-344-9269
	Havana
	Mason District Hospital
		Nguyet Le-Lindqwister	Ph:  309-543-4431
	Macomb
	Illinois CancerCare - Macomb
		Nguyet Le-Lindqwister	Ph:  309-833-3503
	McDonough District Hospital
		Nguyet Le-Lindqwister	Ph:  309-833-4101
	Normal
	BroMenn Regional Medical Center
		Nguyet Le-Lindqwister	Ph:  309-454-1400
	Community Cancer Center
		Nguyet Le-Lindqwister	Ph:  309-451-8500
	Illinois CancerCare - Community Cancer Center
		Nguyet Le-Lindqwister	Ph:  309-662-2102
	Ottawa
	Community Hospital of Ottawa
		Nguyet Le-Lindqwister	Ph:  815-433-3100
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		Nguyet Le-Lindqwister	Ph:  815-431-9270
	Pekin
	Cancer Treatment Center at Pekin Hospital
		Nguyet Le-Lindqwister	Ph:  309-353-0512
	Illinois CancerCare - Pekin
		Nguyet Le-Lindqwister	Ph:  309-353-0214
	Peoria
	CCOP - Illinois Oncology Research Association
		Nguyet Le-Lindqwister	Ph:  309-243-3605 800-793-2262
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		Nguyet Le-Lindqwister	Ph:  309-243-3000
	OSF St. Francis Medical Center
		Nguyet Le-Lindqwister	Ph:  309-655-2000
	Proctor Hospital
		Nguyet Le-Lindqwister	Ph:  309-691-1000
	Peru
	Illinois CancerCare - Peru
		Nguyet Le-Lindqwister	Ph:  815-780-3185
	Illinois Valley Community Hospital
		Nguyet Le-Lindqwister	Ph:  815-223-3000
	Princeton
	Perry Memorial Hospital
		Nguyet Le-Lindqwister	Ph:  815-875-2811
	Spring Valley
	Illinois CancerCare - Spring Valley
		Nguyet Le-Lindqwister	Ph:  815-664-1487
Indiana
	Elkhart
	Elkhart Clinic, LLC
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Michiana Hematology-Oncology, PC - Elkhart
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Mishawaka
	Michiana Hematology-Oncology, PC - South Bend
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Plymouth
	Michiana Hematology Oncology PC - Plymouth
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Michiana Hematology-Oncology, PC - South Bend
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Westville
	Michiana Hematology Oncology PC - La Porte
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Maryland
	Baltimore
	Good Samaritan Hospital of Maryland
		Bridget Oppong	Ph:  410-532-8000
	Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
		Clinical Trials Office - Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Ph:  443-777-7364
	Union Memorial Hospital
		Bridget Oppong	Ph:  410-554-2000
	Bethesda
	National Naval Medical Center
		David Van Echo	Ph:  301-295-5706
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Judy Garber, MD	Ph:  617-632-2282
	Lowell
	Lowell General Hospital
		Judy Garber, MD	Ph:  617-632-2282
	Newton
	Newton-Wellesley Hospital
		Judy Garber, MD	Ph:  617-632-2282
	South Weymouth
	Dana-Farber/Brigham and Women's Cancer Center at South Shore
		Judy Garber, MD	Ph:  617-632-2282
Michigan
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Gilbert Padula	Ph:  616-966-8000
	Big Rapids
	Mecosta County Medical Center
		Gilbert Padula	Ph:  231-796-8691
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Gilbert Padula	Ph:  616-391-2799
	CCOP - Grand Rapids
		Gilbert Padula	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Gilbert Padula	Ph:  616-752-5222
	Muskegon
	Mercy General Health Partners
		Gilbert Padula	Ph:  231-672-2000
	Saint Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Lakeside Cancer Specialists, PLLC
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Traverse City
	Munson Medical Center
		Gilbert Padula	Ph:  231-935-6202
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Missouri
	Chesterfield
	Saint Luke's Hospital
		Donald Busiek, MD	Ph:  314-205-6737
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Stephen Lemon, MD, MPH	Ph:  402-354-5860
New Hampshire
	Concord
	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
		Douglas Weckstein, MD	Ph:  603-622-6484
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Douglas Weckstein, MD	Ph:  603-622-6484
	Laconia
	Lakes Region General Hospital
		Douglas Weckstein, MD	Ph:  603-622-6484
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Elmhurst
	Elmhurst Hospital Center
		Clinical Trials Office - Elmhurst Hospital Center	Ph:  718-883-3177
	Glens Falls
	Charles R. Wood Cancer Center at Glens Falls Hospital
		Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital	Ph:  518-926-6700
	Jamaica
	Queens Cancer Center of Queens Hospital
		Lucien Cardinal, II	Ph:  718-883-4031
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
	Utica
	Faxton Regional Cancer Center
		Atul Butala, MD, FACP	Ph:  315-798-9300
North Carolina
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Raleigh
	Rex Cancer Center at Rex Hospital
		Clinical Trials Office - Rex Cancer Center	Ph:  919-784-7209
	Wilmington
	Zimmer Cancer Center at New Hanover Regional Medical Center
		Cyrus Kotwall, MD	Ph:  910-763-4630
	Winston-Salem
	Forsyth Regional Cancer Center at Forsyth Medical Center
		Clinical Trials Office - Forsyth Regional Cancer Center at Forsyth Medical Center	Ph:  336-277-8887
Ohio
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: Jamesline@osumc.edu
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
Oklahoma
	Oklahoma City
	Cancer Care Associates - Mercy Campus
		Alan Hollingsworth	Ph:  405-751-4343
	Oklahoma University Cancer Institute
		Shubham Pant	Ph:  405-271-6822
South Carolina
	Greenville
	Cancer Centers of the Carolinas - Faris Road
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph:  864-241-6251
	Greenwood
	Self Regional Cancer Center at Self Regional Medical Center
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
	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
Tennessee
	Kingsport
	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
		Clinical Trials Office - Christine LaGuardia Phillips Cancer Center	Ph:  423-224-5593
Texas
	Laredo
	Doctor's Hospital of Laredo
		Gary Unzeitig, MD	Ph:  956-726-3691
Vermont
	Berlin
	Mountainview Medical
		Michelle Sowden	Ph:  802-223-6196
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Charlottesville
	Martha Jefferson Hospital Cancer Care Center
		Robert Pritchard, MD	Ph:  434-982-8390

Registry Information
Official Title		Vitamin D and Breast Cancer Biomarkers
Trial Start Date		2010-10-15
Trial Completion Date		2014-10-31 (estimated)
Registered in ClinicalTrials.gov		NCT01224678
Date Submitted to PDQ		2010-10-13
Information Last Verified		2012-10-04

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