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

July 8, 2014 updated by: Judy E. Garber, MD, Dana-Farber Cancer Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
AstraZeneca
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Lisa Diller, MD, Dana-Farber Cancer Institute
  • Principal Investigator: Judy Garber, MD, MPH, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe