Overview

Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
Female
Summary
This proposal is for a pilot study of 20 premenopausal women at high risk for breast cancer development who will receive high dose vitamin D3, cholecalciferol 20,000 IU (2 capsules) weekly, or 30,000 IU (3 capsules) weekly, for 1 year. The primary objective of this study is to determine the feasibility of a 1-year intervention of vitamin D in this study population. Secondary objectives include evaluating the biologic effects of vitamin D supplementation on blood based and image-based biomarkers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Katherine D. Crew
Collaborator:
Prevent Cancer Foundation
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- Elevated risk of breast cancer defined as having at least one of the following: (1)
Predicted 5-year modified Gail model risk of 1.7% or greater, (2) Lobular carcinoma in
situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of
ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the
contralateral breast.

- Age 21 years or older.

- Premenopausal defined as < 6 months since the last menstrual period, no prior
bilateral oophorectomy, not on estrogen replacement, and serum Follicle-stimulating
hormone (FSH) values consistent with institutional normal values for the premenopausal
state.

- Normal breast exam and mammogram (BIRADS score of 1 or 2).

- Baseline mammographic density ≥25% as assessed qualitatively by the mammographer
(25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense
breasts"; >75% = "extremely dense breasts").

- Baseline serum 25-hydroxyvitamin D <32 ng/ml.

- Prior tamoxifen use is allowed provided treatment is discontinued at least 28 days
prior to enrollment.

- Willingness to allow submission of core needle breast biopsy for pathology review and
collection of blood for biomarker analysis and banking.

- At least one breast available for imaging and biopsy.

- Willingness to not take calcium or vitamin D supplements during the one year
intervention, due to the potential risk of hypercalcemia/hypercalciuria with high dose
vitamin D. Premenopausal women who need to take calcium supplementation for any
medical condition will be excluded from the study. Dietary restrictions on calcium
intake may be imposed if the subject is found to have borderline high serum or urine
levels of calcium during the study intervention and a list of dietary sources of
calcium will be provided.

- Normal serum calcium.

- No history of kidney stones.

- Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate
aminotransferase (AST), alanine transaminase (ALT) and alkaline phosphatase < 2.0 x
the institutional upper limit of normal (IULN).

- No hypersensitivity reactions to vitamin D.

- Performance status of 0 or 1.

- Not pregnant or nursing.

- Agree to use effective contraception, hormone-based oral contraceptives allowed but
switching birth control methods is discouraged while on-study.

- No significant medical or psychiatric condition that would preclude study completion.

Exclusion Criteria:

- Not meeting one or any of inclusion criteria