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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165308
• Other study ID #: 00-253
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: July 8, 2014
• Start date: April 2001
• Est. completion date: June 2009

Study information

• Verified date: July 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2009
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hodgkin Disease
• Hodgkin's Disease

Intervention

Drug:
• Tamoxifen
Given orally, daily for one year.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	AstraZeneca, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.		2 years	No
Secondary	To determine the safety and effect on quality of life in participating women.		2 years	Yes