Recruiting
Phase 3

hCG

Sponsor:

New York Presbyterian Hospital

Code:

NCT00808522

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

hCG

Study Details

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

Conditions

Breast Cancer

Study ID

NCT00808522

Start date

Dec, 2008

Status verified date

Dec, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: hCG

Patients at high risk for breast cancer will be treated with hCG

no intervention: routine care

Patients receiving routine care will be followed

Interventions

hCG

recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.

Primary 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. [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

New York Downtown Hospital

Recruiting

New York, New York, United States, 10038

Contacts

More Information

Sponsor

New York Presbyterian Hospital

Last update posted

Dec 16, 2008

Last verified

Dec, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Presbyterian Hospital on 2008-12-16.