Status:
COMPLETED
Vitamin D and Breast Cancer Biomarkers in Female Patients
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 55 years
Phase:
PHASE3
Brief Summary
RATIONALE: Vitamin D may help prevent breast cancer. PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.
Detailed Description
OBJECTIVES: Primary * To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. Secondary * To explor...
Eligibility Criteria
Inclusion
- Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level \< 20.
- Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are eligible.
- Prior Treatment
- Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.
- Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.
- Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.
- Vitamin D Use
- Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.
- Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.
- Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.
- Patients with a history of breast implants or breast reduction are not eligible.
- Patients with two or more bone fractures in the past five years are not eligible.
- Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.
- Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.
- Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.
- Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.
- Required initial laboratory values - Calcium \< 10.5 mg/dL
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01224678
Start Date
October 1 2010
End Date
December 1 2014
Last Update
October 8 2024
Active Locations (103)
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1
Regional Medical Center
Anniston, Alabama, United States, 36207
2
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
3
Camino Medical Group - Treatment Center
Mountain View, California, United States, 94040
4
El Camino Hospital Cancer Center
Mountain View, California, United States, 94040