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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
AstraZeneca
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165308
First received: September 9, 2005
Last updated: October 30, 2009
Last verified: October 2009
History of Changes
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 55
Study Start Date: April 2001
Estimated Study Completion Date: May 2010
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165308

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

No publications provided

Responsible Party: Judy Garber, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165308     History of Changes
Other Study ID Numbers: 00-253
Study First Received: September 9, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Hodgkin Disease
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on October 16, 2012