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

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

Detailed Description
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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.

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

Conditions
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Hodgkin's Disease, Breast Cancer

Intervention / Treatment
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* Drug: Tamoxifen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen<br>Single arm: Tamoxifen 20mg daily | Drug: Tamoxifen<br>* Given orally, daily for one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and effect on quality of life in participating women. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin's disease, breast cancer prevention, tamoxifen