Clinical trial NCT00165308: Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors
Official title: A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin's Disease
Breast Cancer
Keywords: Hodgkin's disease
breast cancer prevention
tamoxifen
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: AstraZeneca
First posted: 2005-09-14
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the safety and effect on quality of life in participating women.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Judy Garber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Lisa Diller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boucher AA, Blaes AH. Prophylactic mastectomy: a treatment alternative for Hodgkin survivors? Clin Breast Cancer. 2013 Oct;13(5):307-8. doi: 10.1016/j.clbc.2013.06.001. Epub 2013 Jul 26. No abstract available.