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Hormone Therapy

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

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 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

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
therapeutic conventional surgery
2003
Completed Phase 3
~12900
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,526 Total Patients Enrolled
42 Trials studying Breast Cancer
6,638 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,989 Total Patients Enrolled
944 Trials studying Breast Cancer
1,543,953 Patients Enrolled for Breast Cancer
Jeffrey Weitzel, MDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Deslorelin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00080756 — Phase 2
Breast Cancer Research Study Groups: Group 1 (planned risk reduction mastectomy), Group 2 (continued survaillance)
Breast Cancer Clinical Trial 2023: Deslorelin Highlights & Side Effects. Trial Name: NCT00080756 — Phase 2
Deslorelin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00080756 — Phase 2
~1 spots leftby Sep 2025
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