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
brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
About this trial
This is an interventional prevention trial for brca1 Mutation Carrier focused on measuring breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
Eligibility Criteria
Inclusion Criteria: Patients must generally be in good health with lab values and physical examination within normal limits Known high risk of breast cancer due to BRCA mutation or empiric risk > 30% lifetime by the Claus model No evidence or history of pervious cancer, except non-melanoma skin cancer Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2) Prior tubal ligation or willing to use a non-hormonal barrier method of contraception Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations Must be current non-smoker Exclusion Criteria: GnRHA treatment within 12 months of study entry Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant) Pregnant or breast-feeding or have been so in the last six months Immeasurable breast density on mammogram
Sites / Locations
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1 (planned risk reduction mastectomy)
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.