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

  Show 103 Study Locations
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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014