Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital AstraZeneca
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165308

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Hodgkin's Disease

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors

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 2008
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Intervention Details:

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:	Dana-Farber Cancer Institute ( Judy Garber, MD, MPH )
Study ID Numbers:	00-253
Study First Received:	September 9, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00165308 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Hodgkin's disease
breast cancer prevention
tamoxifen

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Immunoproliferative Disorders
Skin Diseases
Antineoplastic Agents, Hormonal
Hodgkin Lymphoma, Adult
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Hodgkin's Disease

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Hormones
Tamoxifen
Estrogen Receptor Modulators
Lymphatic Diseases
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Neoplasms by Histologic Type
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Skin Diseases
Immune System Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009