Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01097278
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2010-03-31
Brief Title:
S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Cholecalciferol may prevent breast cancer in premenopausal women
PURPOSE This randomized phase II trial is studying how well cholecalciferol works in preventing breast cancer in premenopausal women
PURPOSE This randomized phase II trial is studying how well cholecalciferol works in preventing breast cancer in premenopausal women
Detailed Description:
OBJECTIVES
To assess whether mammographic density is reduced in premenopausal women at high risk of breast cancer taking high-dose vitamin D3 oral cholecalciferol 20000 IU weekly vs placebo for 1 year
To assess whether proliferation as measured by Ki-67 staining of breast epithelial cells is reduced in women receiving these treatments
To explore the difference in the expression of other biomarkers including cleaved caspase-3 apoptosis marker ER vitamin D receptor VDR and 1α-hydroxylase in breast tissue obtained from these women
To assess whether parathyroid hormone IGF-1 IGFBP-3 25OHD and 125OHD serum levels are altered in these women at baseline and at 6 and 12 months
To explore whether a change in mammographic density correlates with polymorphisms in the VDR gene
To assess other sources of vitamin D sunlight exposure diet in these women using a validated questionnaire administered at baseline and at 12 and 24 months
To collect and bank serum plasma and breast tissue from these women before and after a 1-year intervention with vitamin D for future biomarker analysis
To assess the toxicity of high-dose cholecalciferol compared to placebo in this setting
OUTLINE This is a multicenter study Participants are stratified according to baseline serum 25OHD level 20 ngmL vs 20-32 ngmL or 50 nmolL vs 50-80 nmolL baseline mammographic density 11-50 vs 50 and designated biopsy site yes vs no Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral cholecalciferol once weekly and oral vitamin D once daily Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity
Arm II Participants receive oral placebo once weekly and oral vitamin D once daily Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity
Blood samples are collected at baseline and periodically thereafter for biomarkers and 25OHD level Participants undergo a mammogram at baseline and at 12 months Participants may also undergo random core-needle breast biopsy at baseline and at 12 months
Participants complete a questionnaire at baseline and at 12 and 24 months
After completion of study therapy participants are followed up at 1 and 12 months
To assess whether mammographic density is reduced in premenopausal women at high risk of breast cancer taking high-dose vitamin D3 oral cholecalciferol 20000 IU weekly vs placebo for 1 year
To assess whether proliferation as measured by Ki-67 staining of breast epithelial cells is reduced in women receiving these treatments
To explore the difference in the expression of other biomarkers including cleaved caspase-3 apoptosis marker ER vitamin D receptor VDR and 1α-hydroxylase in breast tissue obtained from these women
To assess whether parathyroid hormone IGF-1 IGFBP-3 25OHD and 125OHD serum levels are altered in these women at baseline and at 6 and 12 months
To explore whether a change in mammographic density correlates with polymorphisms in the VDR gene
To assess other sources of vitamin D sunlight exposure diet in these women using a validated questionnaire administered at baseline and at 12 and 24 months
To collect and bank serum plasma and breast tissue from these women before and after a 1-year intervention with vitamin D for future biomarker analysis
To assess the toxicity of high-dose cholecalciferol compared to placebo in this setting
OUTLINE This is a multicenter study Participants are stratified according to baseline serum 25OHD level 20 ngmL vs 20-32 ngmL or 50 nmolL vs 50-80 nmolL baseline mammographic density 11-50 vs 50 and designated biopsy site yes vs no Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral cholecalciferol once weekly and oral vitamin D once daily Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity
Arm II Participants receive oral placebo once weekly and oral vitamin D once daily Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable toxicity
Blood samples are collected at baseline and periodically thereafter for biomarkers and 25OHD level Participants undergo a mammogram at baseline and at 12 months Participants may also undergo random core-needle breast biopsy at baseline and at 12 months
Participants complete a questionnaire at baseline and at 12 and 24 months
After completion of study therapy participants are followed up at 1 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-02032 | OTHER | NCI | httpsreporternihgovquickSearchU10CA037429 |
| S0812 | OTHER | None | None |
| U10CA037429 | NIH | None | None |