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

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