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

Not Applicable

Completed

• Conditions: Hodgkin's Disease; Breast Cancer
• Interventions: Drug: Tamoxifen

• Registration Number: NCT00165308
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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 Timeline

• Study Start: 2001-04
• Primary Completion: 2004-03
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Study Completion: 2009-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Tamoxifen	Single arm: Tamoxifen 20mg daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To determine the safety and effect on quality of life in participating women.	2 years

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States