Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
hCG
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Chemoprevention, Tamoxifen, Breast density, Hcg
Eligibility Criteria
Inclusion Criteria:
- On tamoxifen therapy for the treatment or prevention of breast cancer.
- Must have at least one remaining breast.
Exclusion Criteria:
- Pregnant or nursing.
- 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.
Sites / Locations
- New York Downtown HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hCG
routine care
Arm Description
Patients at high risk for breast cancer will be treated with hCG
Patients receiving routine care will be followed
Outcomes
Primary Outcome Measures
The investigators will be looking at the mammographic breast density at the start of the trial and then every 6 months for 2 years. The treatment arm will have 30 injections of Hcg over a 60 day period.
Secondary Outcome Measures
Evaluation of breast cytology and serum hormone levels at 6 monthly intervals over the course of the study.
Full Information
NCT ID
NCT00808522
First Posted
December 13, 2008
Last Updated
December 15, 2008
Sponsor
New York Presbyterian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00808522
Brief Title
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women
Official Title
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
New York Presbyterian Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate whether hCG will result in a decrease in breast density.
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
Pregnancy has been associated with a decreased risk of breast cancer. This has been reproduced in multiple studies and has been seen in multiple races.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Chemoprevention, Tamoxifen, Breast density, Hcg
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hCG
Arm Type
Experimental
Arm Description
Patients at high risk for breast cancer will be treated with hCG
Arm Title
routine care
Arm Type
No Intervention
Arm Description
Patients receiving routine care will be followed
Intervention Type
Drug
Intervention Name(s)
hCG
Other Intervention Name(s)
Ovidril
Intervention Description
recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.
Primary Outcome Measure Information:
Title
The investigators will be looking at the mammographic breast density at the start of the trial and then every 6 months for 2 years. The treatment arm will have 30 injections of Hcg over a 60 day period.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Evaluation of breast cytology and serum hormone levels at 6 monthly intervals over the course of the study.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On tamoxifen therapy for the treatment or prevention of breast cancer.
Must have at least one remaining breast.
Exclusion Criteria:
Pregnant or nursing.
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.
Facility Information:
Facility Name
New York Downtown Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Del Priore, MD, MPH
Phone
212-312-5268
Email
nydresearch@downtownhospital.org
First Name & Middle Initial & Last Name & Degree
Alan S Klapper, MD
First Name & Middle Initial & Last Name & Degree
Steven Freidman, MD
First Name & Middle Initial & Last Name & Degree
Joseph Bottino, MD
First Name & Middle Initial & Last Name & Degree
Raffi Chalian, MD
12. IPD Sharing Statement
Learn more about this trial
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women
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