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

NCT00808522 | Unknown Phase 3

• 1 other identifier: GD-10-08
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; Chemoprevention; Tamoxifen; Breast density; Hcg

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Evaluation of breast cytology and serum hormone levels at 6 monthly intervals over the course of the study.

  2 years

Study Arms (2)

hCG

EXPERIMENTAL

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

Drug: hCG

routine care

NO INTERVENTION

Patients receiving routine care will be followed

Drug: hCG

Interventions

hCG DRUG

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

Also known as: Ovidril

hCG; routine care

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On tamoxifen therapy for the treatment or prevention of breast cancer.
• Must have at least one remaining breast.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

Study Sites (1)

New York Downtown Hospital

New York, New York, 10038, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Hypertrichosis congenital generalized X-linked

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2008
• First Posted: December 16, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 16, 2008

Record last verified: 2008-12

Locations

US (1)