Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165308
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2005-09-09
Brief Title:
Tamoxifen in the Prevention of Breast Cancer in Hodgkins Disease Survivors
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkins Disease Survivors
Status:
COMPLETED
Status Verified Date:
2014-07
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 purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkins Disease survivors developing breast cancer
Detailed Description:
Patients will receive tamoxifen orally once daily to be taken at home for 1 year They will be asked to complete a daily drug log to keep track of the pills taken or missed
Patients will also be asked to give a bloodDNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future
Patients will also receive a mammogram that will be reviewed by study officials
Side effects will be monitored every 2 months for one year between visits to the clinic
A follow-up visit will be conducted at the 6 month mark and includes a physical exam blood work health and wellness surveys
A follow-up visit will be performed at the 1 year mark and includes a mammogram gynecological exam physical exam blood work health and wellness surveys
Patients active participation will be for 1 year However tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer the patient may decide to stay on tamoxifen for 4 additional years
Patients will also be asked to give a bloodDNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future
Patients will also receive a mammogram that will be reviewed by study officials
Side effects will be monitored every 2 months for one year between visits to the clinic
A follow-up visit will be conducted at the 6 month mark and includes a physical exam blood work health and wellness surveys
A follow-up visit will be performed at the 1 year mark and includes a mammogram gynecological exam physical exam blood work health and wellness surveys
Patients active participation will be for 1 year However tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer the patient may decide to stay on tamoxifen for 4 additional years
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