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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
  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 Phase
Breast Cancer
Dietary Supplement: vitamin D
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D and Breast Cancer Biomarkers

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: October 2010
Primary Completion Date: December 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   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  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
  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
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Marie E. Wood, MD University of Vermont
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01224678     History of Changes
Other Study ID Numbers: CALGB-70806  CDR0000687263 
Study First Received: October 19, 2010
Last Updated: June 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on December 09, 2016