Vitamin D and Breast Cancer Biomarkers in Female Patients

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Dietary Supplement: vitamin D
Other: placebo

Registration Number: NCT01224678

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary: RATIONALE: Vitamin D may help prevent breast cancer.

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	vitamin D	Patients receive oral vitamin D (2000 IU) once daily for 12 months.
Placebo	placebo	Patients receive oral placebo once daily for 12 months.

Primary Outcome Measures

Name	Time	Method
Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms	12 months	To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (102): McDonough District Hospital
🇺🇸
Macomb, Illinois, United States
Eureka Community Hospital
🇺🇸
Eureka, Illinois, United States
Galesburg Clinic, PC
🇺🇸
Galesburg, Illinois, United States
Illinois CancerCare - Macomb
🇺🇸
Macomb, Illinois, United States
Memorial Hospital of South Bend
🇺🇸
South Bend, Indiana, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸
Jupiter, Florida, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Newton-Wellesley Hospital
🇺🇸
Newton, Massachusetts, United States
CCOP - Greenville
🇺🇸
Greenville, South Carolina, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
🇺🇸
Concord, New Hampshire, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸
Kingsport, Tennessee, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸
Burlington, Vermont, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸
Columbus, Ohio, United States
Duke Cancer Institute
🇺🇸
Durham, North Carolina, United States
Louis A. Weiss Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Palo Alto Medical Foundation
🇺🇸
Palo Alto, California, United States
BroMenn Regional Medical Center
🇺🇸
Normal, Illinois, United States
Community Cancer Center
🇺🇸
Normal, Illinois, United States
Illinois CancerCare - Pekin
🇺🇸
Pekin, Illinois, United States
Illinois Valley Community Hospital
🇺🇸
Peru, Illinois, United States
Elkhart Clinic, LLC
🇺🇸
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
🇺🇸
Elkhart, Indiana, United States
Elkhart General Hospital
🇺🇸
Elkhart, Indiana, United States
Howard Community Hospital
🇺🇸
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸
La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
🇺🇸
Westville, Indiana, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸
East Syracuse, New York, United States
Rex Cancer Center of Wakefield
🇺🇸
Raleigh, North Carolina, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
🇺🇸
Glens Falls, New York, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸
Wilmington, North Carolina, United States
Camino Medical Group - Treatment Center
🇺🇸
Mountain View, California, United States
Regional Medical Center
🇺🇸
Anniston, Alabama, United States
Illinois CancerCare - Bloomington
🇺🇸
Bloomington, Illinois, United States
Bendheim Cancer Center at Greenwich Hospital
🇺🇸
Greenwich, Connecticut, United States
Illinois CancerCare - Eureka
🇺🇸
Eureka, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸
Peoria, Illinois, United States
Michiana Hematology Oncology PC - Plymouth
🇺🇸
Plymouth, Indiana, United States
Battle Creek Health System Cancer Care Center
🇺🇸
Battle Creek, Michigan, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
🇺🇸
South Weymouth, Massachusetts, United States
Lakeside Cancer Specialists, PLLC
🇺🇸
Saint Joseph, Michigan, United States
CCOP - Grand Rapids
🇺🇸
Grand Rapids, Michigan, United States
New Hampshire Oncology - Hematology, PA - Hooksett
🇺🇸
Hooksett, New Hampshire, United States
SUNY Upstate Medical University Hospital
🇺🇸
Syracuse, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸
Jamaica, New York, United States
Cancer Centers of the Carolinas - Faris Road
🇺🇸
Greenville, South Carolina, United States
St. Rita's Medical Center
🇺🇸
Lima, Ohio, United States
Greenville Hospital Cancer Center
🇺🇸
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸
Seneca, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
🇺🇸
Spartanburg, South Carolina, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸
Houston, Texas, United States
National Naval Medical Center
🇺🇸
Bethesda, Maryland, United States
Oklahoma University Cancer Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
Cancer Care Associates - Mercy Campus
🇺🇸
Oklahoma City, Oklahoma, United States
Illinois CancerCare - Canton
🇺🇸
Canton, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸
Chicago, Illinois, United States
Doctors Medical Center - San Pablo Campus
🇺🇸
San Pablo, California, United States
Contra Costa Regional Medical Center
🇺🇸
Martinez, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸
Oakland, California, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸
Ottawa, Illinois, United States
El Camino Hospital Cancer Center
🇺🇸
Mountain View, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸
Oakland, California, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸
Peoria, Illinois, United States
Illinois CancerCare - Community Cancer Center
🇺🇸
Normal, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸
Pekin, Illinois, United States
Proctor Hospital
🇺🇸
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸
Peoria, Illinois, United States
Tom K Lee, Incorporated
🇺🇸
Oakland, California, United States
Illinois CancerCare - Spring Valley
🇺🇸
Spring Valley, Illinois, United States
OSF St. Francis Medical Center
🇺🇸
Peoria, Illinois, United States
Illinois CancerCare - Peru
🇺🇸
Peru, Illinois, United States
Michiana Hematology-Oncology, PC - South Bend
🇺🇸
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸
Mishawaka, Indiana, United States
Lowell General Hospital
🇺🇸
Lowell, Massachusetts, United States
Mercy General Health Partners
🇺🇸
Muskegon, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
Mecosta County Medical Center
🇺🇸
Big Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸
Grand Rapids, Michigan, United States
Saint Luke's Hospital
🇺🇸
Chesterfield, Missouri, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸
Saint Joseph, Michigan, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸
Columbia, Missouri, United States
Methodist Estabrook Cancer Center
🇺🇸
Omaha, Nebraska, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
Lakes Region General Hospital
🇺🇸
Laconia, New Hampshire, United States
Elmhurst Hospital Center
🇺🇸
Elmhurst, New York, United States
Rex Cancer Center at Rex Hospital
🇺🇸
Raleigh, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸
Charlotte, North Carolina, United States
Faxton Regional Cancer Center
🇺🇸
Utica, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸
Goldsboro, North Carolina, United States
Mountainview Medical
🇺🇸
Berlin, Vermont, United States
Doctor's Hospital of Laredo
🇺🇸
Laredo, Texas, United States
St. Joseph Medical Center
🇺🇸
Bloomington, Illinois, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸
Oakland, California, United States
Community Hospital of Ottawa
🇺🇸
Ottawa, Illinois, United States