A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
18 Years
35 Years
Female
Hodgkin's Disease, Breast Cancer
Trial Information
A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Judy Garber, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
00-253
NCT ID:
NCT00165308
Start Date:
April 2001
Completion Date:
May 2010
Related Keywords:
- Hodgkin's Disease
- Breast Cancer
- Hodgkin's disease
- breast cancer prevention
- tamoxifen
- Breast Neoplasms
- Hodgkin Disease
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
