Phase 3
Completed N=300
Vitamin D and Breast Cancer Biomarkers in Female Patients
Source: ClinicalTrials.gov NCT01224678 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms — -3.4; -1.4 percent change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms |
-3.4; -1.4 | — |
Eligibility Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01224678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.