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

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: hCG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10038
      • Recruiting
      • New York Downtown Hospital
      • Contact: Giuseppe Del Priore, MD, MPH; Phone Number: 212-312-5268; Email: nydresearch@downtownhospital.org
      • Sub-Investigator: Alan S Klapper, MD
      • Sub-Investigator: Steven Freidman, MD
      • Sub-Investigator: Joseph Bottino, MD
      • Sub-Investigator: Raffi Chalian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hCG; Patients at high risk for breast cancer will be treated with hCG	Drug: hCG; recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.; Other Names: Ovidril
No Intervention: routine care; Patients receiving routine care will be followed	Drug: hCG; recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.; Other Names: Ovidril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Evaluation of breast cytology and serum hormone levels at 6 monthly intervals over the course of the study.	2 years

Collaborators and Investigators

• Sponsor: New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: December 13, 2008
• First Submitted That Met QC Criteria: December 15, 2008
• First Posted (Estimate): December 16, 2008

Study Record Updates

• Last Update Posted (Estimate): December 16, 2008
• Last Update Submitted That Met QC Criteria: December 15, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Breast Cancer; Tamoxifen; Chemoprevention; Breast density; Hcg
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: GD-10-08