Breast Cancer, Hodgkin's Disease
Conditions
Keywords
Hodgkin's disease, breast cancer prevention, tamoxifen
Brief summary
The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's 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 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.
Interventions
DRUGTamoxifen
Given orally, daily for one year.
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
AstraZeneca
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To determine the safety and effect on quality of life in participating women. | 2 years |
Countries
United States
Outcome results
None listed