Vitamin D in Postmenopausal Women at High Risk for Breast Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University
First received: March 9, 2009
Last updated: February 11, 2013
Last verified: February 2013
This is a phase II study which will enroll 40 postmenopausal women who are at high risk for breast cancer development. The goal is to determine whether a one-year intervention of high-dose vitamin D at 2 different doses (20,000 IU weekly or 30,000 IU weekly) will increase circulating blood levels of vitamin D and to obtain preliminary data on the biologic effects of vitamin D for breast cancer prevention.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
||Effects of High-Dose Vitamin D on Circulating Vitamin D Levels and Breast Density in Postmenopausal Women at High Risk for Breast Cancer Development
Primary Outcome Measures:
- The primary endpoint of this study is to determine the level of circulating 25(OH)D levels after a 1-year intervention of vitamin D. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in breast density as assessed by mammography and breast MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
Active Comparator: 1
20,000 IU PO (2 capsules) weekly + matching placebo (1 capsule) x 1 year
Active Comparator: 2
30,000 IU (3 capsules) PO weekly x 1 year
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Elevated risk of breast cancer defined as having at least one of the following: (1) Predicted 5-year modified Gail model risk of 1.67% 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.
- Postmenopausal defined as > 6 months since the last menstrual period, prior bilateral oophrectomy, or serum FSH/LH values consistent with institutional normal values for the postmenopausal state.
- 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.
- Normal breast exam and mammogram (BIRADS score of 1 or 2).
- Prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at least 28 days prior to enrollment.
- At least one breast available for imaging. No bilateral breast implants.
- Willingness to not take vitamin D supplements during the one year intervention, but up to 1000mg of calcium supplementation is allowed.
- Normal serum calcium.
- No history of kidney stones.
- Adequate renal and hepatic function: serum creatinine, bilirubin, AST, ALT and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).
- No hypersensitivity reactions to vitamin D.
- Zubrod performance status of 0 or 1.
- Not on estrogen replacement therapy.
- No significant medical or psychiatric condition that would preclude study completion.
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: NCT00859651
|New York, New York, United States, 10032 |
||Katherine D Crew, MD, MS
No publications provided
||Katherine D. Crew, Assistant Professor of Medicine and Assistant Professor of Epidemiology, Columbia University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 9, 2009
||February 11, 2013
||United States: Institutional Review Board
Keywords provided by Columbia University:
breast cancer chemoprevention
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Neoplasms by Site
Physiological Effects of Drugs
Bone Density Conservation Agents