Breast Cancer
Conditions
Brief summary
This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.
Detailed description
Patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. As well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible. Participants will be assigned to treatment (0, 2000, 4000, 6000 IU/day vitamin D by mouth) based solely on their serum vitamin D levels (Normal: \>40 ng/mL; Low-normal: 31-40 ng/mL; Low: 20-30 ng/mL; Very-low: \<20 ng/mL). Prior to definitive breast cancer surgery, vitamin D level, parathyroid level, and calcium will be reassessed. Samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling. The ultimate plan is to correlate baseline vitamin D levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin D level and by vitamin D supplementation and to see if vitamin D supplementation results in gene expression changes similar to those of the vitamin D sufficient group.
Interventions
DRUGVitamin D
0, 2000, 4000, and 6000 IU per day orally
Sponsors
United States Department of Defense
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. * Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis. * No prior therapy for breast cancer within the past 5 years. * 18 years of age or older. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* History of parathyroid disease, hypercalcemia, or kidney stones. * Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months. * History of renal failure requiring dialysis or kidney transplantation. * Pregnant or nursing * Receiving supplemental calcium \> 1200 mg calcium per day during study. * Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy. * Locally-advanced breast cancer * Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy * Plans for preoperative radiation therapy * Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention. * Any condition potentially interfering with subjects ability to comply with taking study medication. * Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis. * Current participation in another research study that would increase risk to subject, in the opinion of the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | 10 days to 4 weeks post diagnosis. | Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Intervention (No Vitamin D) Patients with breast cancer detected by biopsy | 15 |
| 2000 UI Vitamin D Patients with breast cancer detected by biopsy | 18 |
| 4000 UI Vitamin D Patients with breast cancer detected by biopsy | 11 |
| 6000 UI Vitamin D Patients with breast cancer detected by biopsy | 4 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 |
| Overall Study | Not Eligible | 10 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | No Intervention (No Vitamin D) | 2000 UI Vitamin D | 4000 UI Vitamin D | 6000 UI Vitamin D | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 2 Participants | 1 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 11 Participants | 9 Participants | 3 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 17 Participants | 8 Participants | 2 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 13 Participants | 15 Participants | 7 Participants | 2 Participants | 37 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 11 Participants | 4 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 19 | 0 / 11 | 0 / 4 |
| serious Total, serious adverse events | 0 / 29 | 0 / 19 | 0 / 11 | 0 / 4 |
Outcome results
Primary
Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer
Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes
Time frame: 10 days to 4 weeks post diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Vitamin D Levels | Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | 0 percentage of participants |
| Low-normal Vitamin D Levels | Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | 0 percentage of participants |
| Low Vitamin D Levels | Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | 0 percentage of participants |
| Very-low Vitamin D Levels | Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer | 0 percentage of participants |