Vitamin D and Breast Cancer Biomarkers in Female Patients

September 23, 2024 updated by: Alliance for Clinical Trials in Oncology

Vitamin D and Breast Cancer Biomarkers

RATIONALE: Vitamin D may help prevent breast cancer.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

  1. Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.
  2. Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are eligible.

  3. Prior Treatment

    1. 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 (eg, transdermal patches and vaginal estrogens) is allowed.

    2. Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.

  4. Vitamin D Use

    1. 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.
    2. 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.
  5. Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.
  6. Patients with a history of breast implants or breast reduction are not eligible.
  7. Patients with two or more bone fractures in the past five years are not eligible.
  8. Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.
  9. Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.
  10. Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.
  11. Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.
  12. Required initial laboratory values - Calcium < 10.5 mg/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients receive oral placebo once daily for 12 months.
Other: placebo
Given orally
Experimental: Vitamin D
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
Dietary supplement: vitamin D
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Marie E. Wood, MD, University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimated)

October 20, 2010

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-70806
  • CDR0000687263 (Registry Identifier: NCI Physician Data Query)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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