Vitamin D and Breast Cancer Biomarkers
OBJECTIVES:
Primary
- To evaluate change in mammographic density using the Boyd method after one year of
vitamin D supplementation compared to placebo in premenopausal women.
Secondary
- To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or
placebo supplementation in premenopausal women.
- To explore changes in cellular proliferation (atypia and Ki67) in response to one year
of vitamin D or placebo supplementation in premenopausal women.
- To explore correlations between change in breast cancer biomarkers (density, IGF1,
atypia, and Ki67) with each other and with change in vitamin D levels.
- To compare methods of mammographic density analysis.
- To validate a recently developed sunlight questionnaire.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline vitamin
D (sufficient [≥ 30 ng/mL or ≥ 75 mmol/L] vs insufficient [< 30 ng/mL or < 75 mmol/L]) and
institutional random periareolar fine-needle aspiration (RPFNA) status (performs RPFNA vs
does not perform RPFNA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo once daily for 12 months.
- Arm II: Patients receive oral vitamin D (2000 IU) once daily for 12 months. Tissue and
blood samples are collected at baseline and at 12 months for laboratory biomarker
analysis. Patients also complete questionnaires at baseline and at 12 months.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms
No
Marie E. Wood, MD
Study Chair
University of Vermont
United States: Federal Government
CDR0000687263
NCT01224678
October 2010
Name | Location |
---|---|
National Naval Medical Center | Bethesda, Maryland 20889 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
St. Rita's Medical Center | Lima, Ohio 45801 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Greenville | Greenville, South Carolina 29615 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Elmhurst Hospital Center | Elmhurst, New York 11373 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Eureka Community Hospital | Eureka, Illinois 61530 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Doctor's Hospital of Laredo | Laredo, Texas 78041 |
Mountainview Medical | Berlin, Vermont 05602 |
Palo Alto Medical Foundation | Palo Alto, California 94301 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Cancer Care Associates - Mercy Campus | Oklahoma City, Oklahoma 73120 |
Lowell General Hospital | Lowell, Massachusetts 01854 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
Duke Cancer Institute | Durham, North Carolina 27710 |
Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Newton-Wellesley Hospital | Newton, Massachusetts 02462 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Faxton Regional Cancer Center | Utica, New York 13502 |
Fountain Valley, California 92708 | |
Regional Medical Center | Anniston, Alabama 36202 |
Camino Medical Group - Treatment Center | Mountain View, California 94040 |
Bendheim Cancer Center at Greenwich Hospital | Greenwich, Connecticut 06830 |
Dana-Farber/Brigham and Women's Cancer Center at South Shore | South Weymouth, Massachusetts 02190 |
Rex Cancer Center of Wakefield | Raleigh, North Carolina 27614 |