Deslorelin + Hormone Therapy for Breast Cancer Prevention in High-Risk Women

Phase 2

Waitlist Available

Led By Jeffrey Weitzel, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying deslorelin combined with low-dose add-back estradiol and testosterone to see how well it works in preventing breast cancer in premenopausal women who are at high risk for this disease.

Who is the study for?

This trial is for premenopausal women at high risk for breast cancer due to BRCA mutations or a lifetime risk over 30%. Participants must be non-smokers, in good health, not pregnant or breastfeeding recently, and willing to use non-hormonal contraception. Women planning a preventive mastectomy or continued surveillance can join.

What is being tested?

The study tests if deslorelin combined with low-dose estradiol and testosterone can prevent breast cancer in women at high risk. It includes monitoring hormone levels, quality of life assessments, and regular check-ups to see the effects on preventing cancer.

What are the potential side effects?

Possible side effects may include symptoms related to hormonal changes such as mood swings, hot flashes, decreased sex drive, and potential injection site reactions from the treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 (planned risk reduction mastectomy)Experimental Treatment6 Interventions

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.

Group II: Group 2 (continued survaillance)Active Control6 Interventions

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

therapeutic estradiol

2011

N/A

~20

therapeutic testosterone

2004

Completed Phase 3

~150