S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01097278 |
Recruitment Status
:
Completed
First Posted
: April 1, 2010
Last Update Posted
: November 24, 2017
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | March 31, 2010 | |||
First Posted Date ICMJE | April 1, 2010 | |||
Last Update Posted Date | November 24, 2017 | |||
Actual Study Start Date ICMJE | November 1, 2011 | |||
Actual Primary Completion Date | August 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in mammographic density at 12 months compared to baseline [ Time Frame: 12 months ] | |||
Original Primary Outcome Measures ICMJE |
Change in mammographic density at 12 months compared to baseline | |||
Change History | Complete list of historical versions of study NCT01097278 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months [ Time Frame: 12 months ] | |||
Original Secondary Outcome Measures ICMJE |
Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer | |||
Official Title ICMJE | Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer | |||
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. |
|||
Detailed Description | OBJECTIVES:
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.
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 ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized Phase 2 study Masking: Double (Participant, Investigator)Primary Purpose: Prevention |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
208 | |||
Original Estimated Enrollment ICMJE |
200 | |||
Actual Study Completion Date | September 2017 | |||
Actual Primary Completion Date | August 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01097278 | |||
Other Study ID Numbers ICMJE | S0812 S0812 ( Other Identifier: SWOG ) U10CA037429 ( U.S. NIH Grant/Contract ) NCI-2011-02032 ( Other Identifier: NCI ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Southwest Oncology Group | |||
Study Sponsor ICMJE | Southwest Oncology Group | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
|
|||
PRS Account | Southwest Oncology Group | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |