S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01097278|
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : November 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer||Dietary Supplement: cholecalciferol Other: placebo||Not Applicable|
- To assess whether mammographic density is reduced in premenopausal women at high risk of breast cancer taking high-dose vitamin D3 (oral cholecalciferol 20,000 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, 25(OH)D, and 1,25(OH)D 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 25(OH)D level (< 20 ng/mL vs 20-32 ng/mL or < 50 nmol/L vs 50-80 nmol/L), 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 25(OH)D 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Phase 2 study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer|
|Actual Study Start Date :||November 1, 2011|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||September 2017|
Experimental: 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.
Dietary Supplement: cholecalciferol
Active Comparator: 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.
Dietary Supplement: cholecalciferol
- Change in mammographic density at 12 months compared to baseline [ Time Frame: 12 months ]
- Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097278
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|Principal Investigator:||Katherine D. Crew, MD, MS||Columbia University|