Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
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.
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300
Jeffrey Weitzel, MD
City of Hope Medical Center
United States: Food and Drug Administration
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|