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Clinical Trials (PDQ®)

Vitamin D and Breast Cancer Biomarkers in Female Patients

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, PreventionTemporarily closed55 and underNCI, OtherCDR0000687263
CALGB-70806, NCT01224678

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Marie E. WoodStudy Chair

Trial Sites

U.S.A.
Missouri
  Chesterfield
 Saint Luke's Hospital
 Donald F. Busiek Ph: 314-205-6936
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Paul S Dale Ph: 573-882-7440
North Carolina
  Raleigh
 Rex Cancer Center at Rex Hospital
 JoEllen C Speca Ph: 919-784-7209
 Rex Cancer Center of Wakefield
 Nirav S Dhruva
  Email: calgbco@calgb.org
Virginia
  Charlottesville
 Martha Jefferson Hospital Cancer Care Center
 Robert S. Pritchard Ph: 434-654-8400

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01224678
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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