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

NCT00976339 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: AAAC3089
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

Breast cancer; Vitamin D; Premenopausal

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Successfully Completed the 1-year Intervention

  1 year

Secondary Outcomes (1)

• Change in Mammographic Breast Density

  1 year

Study Arms (2)

Cholecalciferol 20,000 IU

EXPERIMENTAL

Participants will receive Cholecalciferol 20,000 IU (2 capsules) weekly for one year.

Drug: Cholecalciferol

Cholecalciferol 30,000 IU

EXPERIMENTAL

Participants will receive Cholecalciferol 30,000 IU (3 capsules) weekly for one year.

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D. Cholecalciferol will be available in gel capsule form at 10,000 IU (0.25 mg cholecalciferol) each.

Also known as: Vitamin D3

Cholecalciferol 20,000 IU; Cholecalciferol 30,000 IU

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Katherine D. Crew: lead
• Prevent Cancer Foundation: collaborator

Study Sites (1)

Columbia University Medical Center Herbert Irving Cancer Center

New York, New York, 10032, United States

Location

Related Publications (25)

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• Hershman, D. L., McMahon, D., Irani, D., Cucchiara, G., Crew, K. D., Raptis, G., and Shane, E. High prevalence of vitamin D deficiency in premenopausal women with early-stage breast cancer. Proc Am Soc Clin Oncol, pp. Abst #8568. Atlanta, 2006.

  BACKGROUND

• Chlebowski, R. T., Johnson, K. C., Kooperberg, C., Hubbell, A., Lane, D., O'Sullivan, M., Cummings, S., Rohan, T., Khandekar, J., and Investigators, T. W. s. H. I. The Women's Health Initiative randomized trial of calcium plus vitamin D: effects on breast cancer and arthralgias. Proceedings of the American Society of Clinical Oncology 24, pp. LBA6. Atlanta, 2006.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Data for this study alone was not analyzed.

Results Point of Contact

• Title: Dr. Katherine Crew
• Organization: Columbia University

kd59@cumc.columbia.edu

212-305-1732

Study Officials

• Katherine Crew, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Florence Irving Assistant Professor of Medicine and Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 29, 2017
• Results First Posted: June 15, 2016

Record last verified: 2017-08

Locations

US (1)