Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors
|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: NCT00165308|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : July 9, 2014
|Condition or disease||Intervention/treatment|
|Hodgkin's Disease Breast Cancer||Drug: Tamoxifen|
- 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 blood/DNA 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors|
|Study Start Date :||April 2001|
|Primary Completion Date :||March 2004|
|Study Completion Date :||June 2009|
U.S. FDA Resources
Single arm: Tamoxifen 20mg daily
Given orally, daily for one year.
- To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer. [ Time Frame: 2 years ]
- To determine the safety and effect on quality of life in participating women. [ Time Frame: 2 years ]
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): NCT00165308
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Judy Garber, MD, MPH||Dana-Farber Cancer Institute|
|Principal Investigator:||Lisa Diller, MD||Dana-Farber Cancer Institute|