Vitamin D and Breast Cancer Biomarkers in Female Patients

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Dietary Supplement: vitamin D; Other: placebo	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	Vitamin D and Breast Cancer Biomarkers
Study Start Date :	October 2010
Actual Primary Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change (between baseline and year 1) in mammographic density by the Boyd method compared between arms [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :

1. Change (between baseline and year 1) in serum biomarker (IGF1) compared between arms [ Time Frame: Up to 12 months ]
2. Change (between baseline and year 1) in tissue biomarker (atypia) compared between arms [ Time Frame: Up to 12 months ]
3. Change (between baseline and year 1) in tissue biomarker (Ki67) compared between arms [ Time Frame: Up to 12 months ]
4. Change (between baseline and year 1) in breast cancer biomarker (density) compared between arms [ Time Frame: Up to 12 months ]
5. Change (between baseline and year 1) in breast cancer biomarker (IGF1) compared between arms [ Time Frame: Up to 12 months ]
6. Change (between baseline and year 1) in breast cancer biomarkers (atypia) compared between arms [ Time Frame: Up to 12 months ]
7. Change (between baseline and year 1) in breast cancer biomarkers (Ki67) compared between arms [ Time Frame: Up to 12 months ]
8. Reported time spent outside as assessed using the Sunlight Questionnaire [ Time Frame: Up to 12 month ]
9. Change (between baseline and year 1) in breast density measurements [ Time Frame: Up to 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	up to 55 Years (Child, Adult)
Sexes 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

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  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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT01224678 History of Changes
Other Study ID Numbers:	CALGB-70806; CDR0000687263 ( Registry Identifier: NCI Physician Data Query )
First Posted:	October 20, 2010
Last Update Posted:	June 21, 2016
Last Verified:	June 2016

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