Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Presbyterian Hospital

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.