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A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors

18 Years
35 Years
Open (Enrolling)
Hodgkin's Disease, Breast Cancer

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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

- 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:


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:


Principal Investigator

Judy Garber, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




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



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617