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

This study has been completed.
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Judy E. Garber, MD, Dana-Farber Cancer Institute Identifier:
First received: September 9, 2005
Last updated: July 8, 2014
Last verified: July 2014
The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.

Condition Intervention
Hodgkin's Disease
Breast Cancer
Drug: Tamoxifen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine the safety and effect on quality of life in participating women. [ Time Frame: 2 years ]

Enrollment: 29
Study Start Date: April 2001
Study Completion Date: June 2009
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamoxifen
Single arm: Tamoxifen 20mg daily
Drug: Tamoxifen
Given orally, daily for one year.

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.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00165308

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Principal Investigator: Judy Garber, MD, MPH Dana-Farber Cancer Institute
Principal Investigator: Lisa Diller, MD Dana-Farber Cancer Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Judy E. Garber, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00165308     History of Changes
Other Study ID Numbers: 00-253
Study First Received: September 9, 2005
Last Updated: July 8, 2014

Keywords provided by Dana-Farber Cancer Institute:
Hodgkin's disease
breast cancer prevention

Additional relevant MeSH terms:
Hodgkin Disease
Breast Diseases
Skin Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Breast Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents processed this record on May 23, 2017