Breast Cancer Clinical Trial

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

Summary

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

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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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

29

Study ID:

NCT00165308

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

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There are 2 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

29

Study ID:

NCT00165308

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

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