Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors

Dana-Farber Cancer Institute

Status

Completed

Conditions

Breast Cancer

Hodgkin's Disease

Treatments

Drug: Tamoxifen

Study type

Interventional

Funder types

Other

Industry

Identifiers

00-253

Details and patient eligibility

About

The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.

Full 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 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.

Enrollment

29 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Females diagnosed with Hodgkin's Disease at age < 35 years
> 5 years from mantle or chest radiation
Current age > 30 years
Has completed childbearing
Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study

Exclusion criteria

History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
Recurrence of Hodgkin's disease in the 5 years before study entry
Current participation in any other cancer prevention study
Current or prior use of tamoxifen
Current use of coumadin
History of deep venous thrombosis, pulmonary embolism, or a condition known to be associated with hypercoagulability
History of cerebrovascular accident
History of macular degeneration
Current use of chemotherapy for benign disease