Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women
NCT ID: NCT00808522
Last Updated: 2008-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
84 participants
INTERVENTIONAL
2008-12-31
2009-12-31
Brief Summary
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High breast density has been associated with an increased risk in breast cancer. It has also been shown that decreasing density with a drug called tamoxifen has resulted in a decreased risk in breast cancer. The investigators are looking at the effect of hCG on breast density in people who are at increased risk of developing breast cancer and our theory postulates that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in breast density in patients who are treated with hCG and tamoxifen versus patients treated with tamoxifen alone. Using this data the investigators will be able to hypothesize that the treatment of hCG will result in a reduction in breast cancer rates in the population and thus make available another drug which can be used to decrease the rates of breast cancer in the population
Detailed Description
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People have been evaluating different hormones and practices associated with pregnancy to determine what factors reduce the risk of developing breast cancer in these patients. These pronounced findings have been evaluated in great detail by multiple scientists and one of the hormones which we think might be associated with a reduction in breast cancer is hCG. This statement has been backed by multiple studies which have looked at the direct effect of hCG on the growth and death of breast cancer cells in the lab and in animal models of breast cancer.
We want to determine if hCG is given to patients who are at increased risk of breast cancer will result in an accentuated decrease in breast cancer risk above and beyond the effect received by conventional breast cancer reducing protocols. Our final outcome in this study will be breast density on mammographic evaluation which is considered a marker for breast cancer. So our study will evaluate whether or not hCG will have an effect on the mammographic breast density.
After recruitment there will be two groups in our study an intervention group and non intervention group. In the intervention group patients would undergo a period of hCG injections which would last a total of 60 days and consist of 30 subcutaneous injections. The non intervention group will continue their conventional chemoprevention medication. Both groups will be followed for teo years and the images, cytology and blood samples will be sent to our labs for evaluation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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hCG
Patients at high risk for breast cancer will be treated with hCG
hCG
recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.
routine care
Patients receiving routine care will be followed
hCG
recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.
Interventions
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hCG
recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have at least one remaining breast.
Exclusion Criteria
* No history of allergic reactions to hCG.
* Patients who have had bilateral mastectomies.
* Uncontrolled thyroid disease.
* Cognitively impaired and unable to consent for the trial.
30 Years
75 Years
FEMALE
No
Sponsors
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New York Presbyterian Hospital
OTHER
Responsible Party
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New Downtown Hospital
Locations
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New York Downtown Hospital
New York, New York, United States
Countries
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Facility Contacts
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Giuseppe Del Priore, MD, MPH
Role: primary
Other Identifiers
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GD-10-08
Identifier Type: -
Identifier Source: org_study_id