Vitamin D in Postmenopausal Women at High Risk for Breast Cancer

NCT00859651 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAD3638
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study which will enroll 20 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.

Conditions

Breast Cancer

Keywords

breast cancer chemoprevention; vitamin D; breast density

Outcome Measures

Primary Outcomes (1)

• Change in Serum 25(OH)D

  25(OH)D level at the end of one year intervention

  Baseline to 1 year

Secondary Outcomes (1)

• Change in Percent Density

  Baseline to 1 year

Study Arms (2)

20,000 IU weekly

ACTIVE COMPARATOR

Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year. Cholecalciferol 20,000 IU (2 active capsules + 1 matching placebo capsule)

Drug: Cholecalciferol; Drug: Placebo capsule

30,000 IU weekly

ACTIVE COMPARATOR

Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year. Cholecalciferol 30,000 IU (3 active capsules)

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

20,000 IU weekly; 30,000 IU weekly

Placebo capsule DRUG

Matching placebo capsules

Also known as: Placebo

20,000 IU weekly

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 1.67% 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 oophorectomy, or serum follicle-stimulating hormone (FSH)/luteinizing hormone (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 (Breast Imaging Reporting and Data System (BIRADS) score of 1 or 2) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. Normal baseline breast magnetic resonance imaging (MRI) (BIRADS score of 1, 2, or 3).
• 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.
• Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase \< 2.0 x the institutional upper limit of normal (IULN).
• Performance status of 0 or 1.

You may not qualify if:

• Other prior malignancy. The following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.
• History of kidney stones.
• Hypersensitivity reactions to vitamin D.
• On estrogen replacement therapy.
• Significant medical or psychiatric condition that would preclude study completion.

Sponsors & Collaborators

• Columbia University: lead
• Avon Foundation: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

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

The investigator combined the data for this study (NCT00859651; n=20) with the data for another study (NCT00976339; n=20). Therefore, the total number of participants analyzed is 40 for Outcome Measures and Adverse Events sections.

Results Point of Contact

• Title: Katherine Crew, MD
• Organization: Columbia University

kd59@cumc.columbia.edu

212-305-1732

Study Officials

• Katherine D Crew, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Associate Professor of Epidemiology

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 27, 2017
• Results First Posted: September 27, 2017

Record last verified: 2017-08

Locations

US (1)