Vitamin D and Breast Cancer Biomarkers in Female Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01224678
First received: October 19, 2010
Last updated: June 17, 2016
Last verified: June 2016

October 19, 2010
June 17, 2016
October 2010
December 2014   (final data collection date for primary outcome measure)
Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01224678 on ClinicalTrials.gov Archive Site
  • Change (between baseline and year 1) in serum biomarker (IGF1) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in tissue biomarker (atypia) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in tissue biomarker (Ki67) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in breast cancer biomarker (density) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in breast cancer biomarker (IGF1) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in breast cancer biomarkers (atypia) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in breast cancer biomarkers (Ki67) compared between arms [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Reported time spent outside as assessed using the Sunlight Questionnaire [ Time Frame: Up to 12 month ] [ Designated as safety issue: No ]
  • Change (between baseline and year 1) in breast density measurements [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Vitamin D and Breast Cancer Biomarkers in Female Patients
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.

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Breast Cancer
  • Dietary Supplement: vitamin D
    Given orally
  • Other: placebo
    Given orally
  • Placebo Comparator: Arm I
    Patients receive oral placebo once daily for 12 months.
    Intervention: Other: placebo
  • Experimental: Arm II
    Patients receive oral vitamin D (2000 IU) once daily for 12 months.
    Intervention: Dietary Supplement: vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Not Provided
December 2014   (final data collection date for primary outcome measure)
  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
Female
up to 55 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224678
CALGB-70806, CALGB-70806, CDR0000687263
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Marie E. Wood, MD University of Vermont
Alliance for Clinical Trials in Oncology
June 2016

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