Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors
A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
1 other identifier
interventional
29
1 country
2
Brief Summary
The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2001
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 9, 2014
July 1, 2014
2.9 years
September 9, 2005
July 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
2 years
Secondary Outcomes (1)
To determine the safety and effect on quality of life in participating women.
2 years
Study Arms (1)
Tamoxifen
EXPERIMENTALSingle arm: Tamoxifen 20mg daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
- AstraZenecacollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 23891588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judy Garber, MD, MPH
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Lisa Diller, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
April 1, 2001
Primary Completion
March 1, 2004
Study Completion
June 1, 2009
Last Updated
July 9, 2014
Record last verified: 2014-07