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

Primary Purpose

Hodgkin's Disease, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hodgkin's Disease focused on measuring Hodgkin's disease, breast cancer prevention, tamoxifen

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tamoxifen

Arm Description

Single arm: Tamoxifen 20mg daily

Outcomes

Primary Outcome Measures

To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.

Secondary Outcome Measures

To determine the safety and effect on quality of life in participating women.

Full Information

First Posted
September 9, 2005
Last Updated
July 8, 2014
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00165308
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease, Breast Cancer
Keywords
Hodgkin's disease, breast cancer prevention, tamoxifen

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Experimental
Arm Description
Single arm: Tamoxifen 20mg daily
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
Given orally, daily for one year.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the safety and effect on quality of life in participating women.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Garber, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Diller, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23891588
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.
Results Reference
derived

Learn more about this trial

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

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