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Hormone Therapy

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

Phase 3
Waitlist Available
Research Sponsored by New York Presbyterian Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 4 trial • 89 Patients • NCT01815138
3%
Ectopic Pregnancy
100%
80%
60%
40%
20%
0%
Study treatment Arm
hCG Given 35 Hours After GnRHa Trigger
hCG Given at Time of GnRHa Trigger

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: hCGExperimental Treatment1 Intervention
Patients at high risk for breast cancer will be treated with hCG
Group II: routine careActive Control1 Intervention
Patients receiving routine care will be followed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hCG
2013
Completed Phase 4
~4280

Find a Location

Who is running the clinical trial?

New York Presbyterian HospitalLead Sponsor
75 Previous Clinical Trials
57,182 Total Patients Enrolled
4 Trials studying Breast Cancer
2,899 Patients Enrolled for Breast Cancer
~5 spots leftby Jan 2026