Status:
COMPLETED
Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer
Lead Sponsor:
Katherine D. Crew
Collaborating Sponsors:
Prevent Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Vitamin D has diverse biological effects relevant to carcinogenesis, including known cross-talk between the vitamin D receptor (VDR) and insulin-like growth factor (IGF) signaling pathways. Based upon...
Eligibility Criteria
Inclusion
- 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
- Not meeting one or any of inclusion criteria
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00976339
Start Date
September 1 2007
End Date
December 1 2013
Last Update
September 29 2017
Active Locations (1)
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1
Columbia University Medical Center Herbert Irving Cancer Center
New York, New York, United States, 10032