Trial Outcomes & Findings for Development of Vitamin D as a Therapy for Breast Cancer - Phase 2 (NCT NCT00656019)
NCT ID: NCT00656019
Last Updated: 2017-12-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
10 days to 4 weeks post diagnosis.
Results posted on
2017-12-02
Participant Flow
Participant milestones
| Measure |
Normal Vitamin D Levels
No additional Vitamin D administered
|
Low-normal Vitamin D Levels
2000 IU dose of Vitamin D per day administered orally
|
Low Vitamin D Levels
4000 IU dose of Vitamin D per day administered orally
|
Very-low Vitamin D Levels
6000 IU dose of Vitamin D per day administered orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
19
|
11
|
4
|
|
Overall Study
COMPLETED
|
15
|
18
|
11
|
4
|
|
Overall Study
NOT COMPLETED
|
14
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Normal Vitamin D Levels
No additional Vitamin D administered
|
Low-normal Vitamin D Levels
2000 IU dose of Vitamin D per day administered orally
|
Low Vitamin D Levels
4000 IU dose of Vitamin D per day administered orally
|
Very-low Vitamin D Levels
6000 IU dose of Vitamin D per day administered orally
|
|---|---|---|---|---|
|
Overall Study
Not Eligible
|
10
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2
Baseline characteristics by cohort
| Measure |
No Intervention (No Vitamin D)
n=15 Participants
Patients with breast cancer detected by biopsy
|
2000 UI Vitamin D
n=18 Participants
Patients with breast cancer detected by biopsy
|
4000 UI Vitamin D
n=11 Participants
Patients with breast cancer detected by biopsy
|
6000 UI Vitamin D
n=4 Participants
Patients with breast cancer detected by biopsy
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
28 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
20 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
48 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
41 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
37 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Normal Vitamin D Levels
n=15 Participants
No additional Vitamin D administered
|
Low-normal Vitamin D Levels
n=18 Participants
2000 IU dose of Vitamin D per day administered orally
|
Low Vitamin D Levels
n=11 Participants
4000 IU dose of Vitamin D per day administered orally
|
Very-low Vitamin D Levels
n=4 Participants
6000 IU dose of Vitamin D per day administered orally
|
|---|---|---|---|---|
|
Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Vitamin D Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D Low-normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D Low
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D Very Low
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place