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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165308
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : July 9, 2014
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
AstraZeneca
Information provided by (Responsible Party):
Judy E. Garber, MD, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Hodgkin's Disease Breast Cancer Drug: Tamoxifen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
Study Start Date : April 2001
Actual Primary Completion Date : March 2004
Actual Study Completion Date : June 2009


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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165308


Locations
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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
AstraZeneca
Investigators
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Principal Investigator: Judy Garber, MD, MPH Dana-Farber Cancer Institute
Principal Investigator: Lisa Diller, MD Dana-Farber Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Judy E. Garber, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165308    
Other Study ID Numbers: 00-253
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Judy E. Garber, MD, Dana-Farber Cancer Institute:
Hodgkin's disease
breast cancer prevention
tamoxifen
Additional relevant MeSH terms:
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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
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