- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165308
Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors
July 8, 2014 updated by: Judy E. Garber, MD, Dana-Farber Cancer Institute
A Feasibility Study of Tamoxifen 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tamoxifen
Single arm: Tamoxifen 20mg daily
|
Given orally, daily for one year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the safety and effect on quality of life in participating women.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Diller, MD, Dana-Farber Cancer Institute
- Principal Investigator: Judy Garber, MD, MPH, Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Primary Completion (Actual)
March 1, 2004
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
July 9, 2014
Last Update Submitted That Met QC Criteria
July 8, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Breast Diseases
- Lymphoma
- Breast Neoplasms
- Hodgkin Disease
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
Other Study ID Numbers
- 00-253
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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