NCT00080756

Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women. PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.

Detailed description

OBJECTIVES: I. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers. II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery. OUTLINE: GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy. GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months. After completion of study treatment, patients are followed up every 6 months for 2 years.

Conditions

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic estradiol	0.35mg/100ul per day as a nasal spray
DRUG	deslorelin	1mg/100ul per day as a nasal spray
DRUG	therapeutic testosterone	0.275mg/100ul per day as a nasal spray
PROCEDURE	therapeutic conventional surgery	Undergo risk reduction mastectomy
OTHER	active surveillance	Undergo continued surveillance
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-03-11
• Primary completion: 2024-09-15
• Completion: 2024-10-15
• First posted: 2004-04-08
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States