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

Phase 3
30 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Chemoprevention
  • Tamoxifen
  • Breast density
  • Hcg
  • Breast Neoplasms



New York Downtown Hospital New York, New York  10038