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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00165308

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), AstraZeneca (Industry)

Enrollment

Locations

Arm

Duration (Months)

14.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Disease Breast Cancer	Drug: Tamoxifen	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2001

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamoxifen Single arm: Tamoxifen 20mg daily	Drug: Tamoxifen Given orally, daily for one year.

Arm

Intervention/Treatment

Experimental: Tamoxifen

Single arm: Tamoxifen 20mg daily

Drug: Tamoxifen

Given orally, daily for one year.

Outcome Measures

Primary Outcome Measures

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

To determine the safety and effect on quality of life in participating women. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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