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Pilot Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Pilot Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer


The investigators plan to conduct a pilot feasibility study in 20 premenopausal women who
are at high risk for breast cancer development who will receive oral cholecalciferol
(vitamin D3) 30,000 IU (n = 10) or 20,000 IU (n = 10) weekly for one year. Pretreatment and
posttreatment mammograms, breast biopsies, and blood will be evaluated for a variety of
biomarkers. The primary objective of this study is to determine the feasibility and toxicity
associated with this 1-year intervention of vitamin D in this study population. The
secondary objective is to obtain preliminary data on the biological effects of vitamin D on
normal breast tissue. The results of this pilot study will be used to implement a larger
multicenter trial of vitamin D for breast cancer chemoprevention.


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 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, 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Safety and Feasibility

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Katherine Crew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Food and Drug Administration

Study ID:

AAAC3089

NCT ID:

NCT00976339

Start Date:

September 2007

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Columbia University Medical Center Herbert Irving Cancer CenterNew York, New York  10032