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Vitamin D and Breast Cancer Biomarkers


N/A
N/A
55 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms

Safety Issue:

No

Principal Investigator

Marie E. Wood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont

Authority:

United States: Federal Government

Study ID:

CDR0000687263

NCT ID:

NCT01224678

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

National Naval Medical CenterBethesda, Maryland  20889
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
St. Rita's Medical CenterLima, Ohio  45801
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
St. Joseph Medical CenterBloomington, Illinois  61701
Eureka Community HospitalEureka, Illinois  61530
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mecosta County Medical CenterBig Rapids, Michigan  49307
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Doctor's Hospital of LaredoLaredo, Texas  78041
Mountainview MedicalBerlin, Vermont  05602
Palo Alto Medical FoundationPalo Alto, California  94301
Saint Luke's HospitalChesterfield, Missouri  63017
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Cancer Care Associates - Mercy CampusOklahoma City, Oklahoma  73120
Lowell General HospitalLowell, Massachusetts  01854
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
Duke Cancer InstituteDurham, North Carolina  27710
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Lakes Region General HospitalLaconia, New Hampshire  03246
Newton-Wellesley HospitalNewton, Massachusetts  02462
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Galesburg Clinic, PCGalesburg, Illinois  61401
Contra Costa Regional Medical CenterMartinez, California  94553-3156
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - MacombMacomb, Illinois  61455
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
Mercy General Health PartnersMuskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Faxton Regional Cancer CenterUtica, New York  13502
Fountain Valley, California  92708
Regional Medical CenterAnniston, Alabama  36202
Camino Medical Group - Treatment CenterMountain View, California  94040
Bendheim Cancer Center at Greenwich HospitalGreenwich, Connecticut  06830
Dana-Farber/Brigham and Women's Cancer Center at South ShoreSouth Weymouth, Massachusetts  02190
Rex Cancer Center of WakefieldRaleigh, North Carolina  27614