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Vitamin D and Breast Cancer Biomarkers in Female Patients

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ClinicalTrials.gov Identifier: NCT01224678
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE October 19, 2010
First Posted Date  ICMJE October 20, 2010
Results First Submitted Date  ICMJE March 6, 2017
Results First Posted Date  ICMJE June 25, 2018
Last Update Posted Date June 25, 2018
Actual Study Start Date  ICMJE October 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
  • Change (between baseline and year 1) in serum biomarker (IGF1) compared between arms
  • Change in tissue biomarkers (atypia and Ki67) compared between arms
  • 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
  • Validation of Sunlight Questionnaire
  • Comparison among 3 methods of breast density determination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Breast Cancer Biomarkers in Female Patients
Official Title  ICMJE Vitamin D and Breast Cancer Biomarkers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: vitamin D
    Given orally
  • Other: placebo
    Given orally
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients receive oral placebo once daily for 12 months.
    Intervention: Other: placebo
  • Experimental: Vitamin D
    Patients receive oral vitamin D (2000 IU) once daily for 12 months.
    Intervention: Dietary Supplement: vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
300
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2010)
250
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01224678
Other Study ID Numbers  ICMJE CALGB-70806
CALGB-70806
CDR0000687263 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Marie E. Wood, MD University of Vermont
PRS Account Alliance for Clinical Trials in Oncology
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP