Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295100
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2006-02-20
Brief Title:
Tamoxifen-MRI Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Cancer Risk and Biomarkers of Tamoxifen Chemoprevention
Status:
COMPLETED
Status Verified Date:
2007-06
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:
The project is a double blind randomized placebo-controlled phase II chemoprevention trial Study participants will be randomly assigned to receive either tamoxifen or placebo for one year Participants will subsequently be followed for one year off of medication The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram
Detailed Description:
The project is a double blind randomized placebo-controlled phase II chemoprevention trial
The study outcomes will be biological markers rather than cancer incidence or mortality Eligible study subjects will be women between the ages 25-45 whose calculated lifetime breast cancer risk is 20 25 by the Couch model
Study participants will be randomly assigned to receive either tamoxifen or placebo for one year Participants will subsequently be followed for one year off of medication
The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram Mammographic density has been correlated with breast cancer risk and reduced breast density may have the added benefit of improving the sensitivity of breast cancer screening in young women Breast density will be employed as a marker of progression-related - proliferative - mechanisms of carcinogenesis
Secondary study outcomes will include estrogen ratios catechol estrogenestradiol and markers of oxidative DNA damage in peripheral blood and urine markers of progression-related - mutational - events in carcinogenesis The responsiveness of these outcomes will suggest the mechanisms through which tamoxifen exerts its preventive effect Persistence of the markers after one year of treatment may also provide early information about the anticipated duration of the tamoxifen effect
The study outcomes will be biological markers rather than cancer incidence or mortality Eligible study subjects will be women between the ages 25-45 whose calculated lifetime breast cancer risk is 20 25 by the Couch model
Study participants will be randomly assigned to receive either tamoxifen or placebo for one year Participants will subsequently be followed for one year off of medication
The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram Mammographic density has been correlated with breast cancer risk and reduced breast density may have the added benefit of improving the sensitivity of breast cancer screening in young women Breast density will be employed as a marker of progression-related - proliferative - mechanisms of carcinogenesis
Secondary study outcomes will include estrogen ratios catechol estrogenestradiol and markers of oxidative DNA damage in peripheral blood and urine markers of progression-related - mutational - events in carcinogenesis The responsiveness of these outcomes will suggest the mechanisms through which tamoxifen exerts its preventive effect Persistence of the markers after one year of treatment may also provide early information about the anticipated duration of the tamoxifen effect
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 |
|---|---|---|---|
| UPC 2100 | None | None | None |