Trial record 2 of 96 for:    70806

Vitamin D and Breast Cancer Biomarkers in Female Patients

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01224678
First received: October 19, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

RATIONALE: Vitamin D may help prevent breast cancer.

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


Condition Intervention
Breast Cancer
Dietary Supplement: vitamin D
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Vitamin D and Breast Cancer Biomarkers

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change (between baseline and year 1) in serum biomarker (IGF1) compared between arms [ Designated as safety issue: No ]
  • Change in tissue biomarkers (atypia and Ki67) compared between arms [ Designated as safety issue: No ]
  • Correlations between change in breast cancer biomarkers (density, IGF1, atypia, and Ki67) with each other and with change in vitamin D levels and vitamin D-receptor expression [ Designated as safety issue: No ]
  • Validation of Sunlight Questionnaire [ Designated as safety issue: No ]
  • Comparison among 3 methods of breast density determination [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: October 2010
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I
Patients receive oral placebo once daily for 12 months.
Other: placebo
Given orally
Experimental: Arm II
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
Dietary Supplement: vitamin D
Given orally

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.
  Eligibility

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Women with breast density ≥ 25% (correlating with the BIRAD-2 category of "scattered fibroglandular densities" or greater)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Premenopausal defined as meeting at least one of the following criteria:

    • Have regular menstrual cycles
    • Have had at least four cycles in the last six months
    • Have had a hysterectomy with ovaries intact and FSH level < 20 IU/L
  • Calcium < 10.5 mg/dL
  • Not pregnant
  • Fertile patients must use effective contraception
  • Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible
  • Patients with two or more bone fractures in the past five years are not eligible
  • Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible
  • Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible
  • Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible

PRIOR CONCURRENT THERAPY:

  • Patients who are currently receiving hormone replacement therapy (estrogen or progesterone) or are taking tamoxifen or raloxifene are not eligible

    • Women who have taken these medications must have stopped for at least 4 months prior to study entry
    • Topical estrogen is allowed
  • Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry
  • Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible

    • Women who agree to stop will need to do so for at least 6 months prior to registration
  • Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram
  • Patients participating in a concurrent breast cancer chemoprevention trial are not eligible
  • No history of breast implants or breast reduction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224678

  Hide Study Locations
Locations
United States, Alabama
Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Camino Medical Group - Treatment Center
Mountain View, California, United States, 94040
El Camino Hospital Cancer Center
Mountain View, California, United States, 94040
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Bay Area Breast Surgeons, Incorporated
Oakland, California, United States, 94609
Tom K Lee, Incorporated
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Pismo Beach, California, United States, 93449
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
United States, Connecticut
Bendheim Cancer Center at Greenwich Hospital
Greenwich, Connecticut, United States, 06830
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
United States, Illinois
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
McDonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Illinois CancerCare - Pekin
Pekin, Illinois, United States, 61603
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Proctor Hospital
Peoria, Illinois, United States, 61614
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States, 61362
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Mercy General Health Partners
Muskegon, Michigan, United States, 49444
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Mount Sinai Medical Center
New York, New York, United States, 10029
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Faxton Regional Cancer Center
Utica, New York, United States, 13502
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
Rex Cancer Center of Wakefield
Raleigh, North Carolina, United States, 27614
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Oklahoma
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, United States, 73120
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37662
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78045
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Marie E. Wood, MD University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01224678     History of Changes
Other Study ID Numbers: CDR0000687263, CALGB-70806
Study First Received: October 19, 2010
Last Updated: February 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014