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Completed

NCT Number: NCT00165308

Tamoxifen in the 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.

Completed

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamoxifen

Drug

Given orally, daily for one year.

Primary outcomes

  1. 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 outcomes

  1. To determine the safety and effect on quality of life in participating women.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • AstraZeneca
  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2009
First posted
Sep 14, 2005
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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