Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial

Inclusion Criteria * Over 21 years of age * Must sign informed consent, witnessed, and dated prior to entry * The participant has an increased risk for developing breast cancer which may include; Atypical Ductal Hyperplasia (ADH), Lobular Carcinoma in situ (LCIS), and/or Atypical Lobular Hyperplasia (ALH) * Performance Status: ECOG 0-1 unless mobility is limited from chronic physical handicap * No clinical evidence of other malignancies (except Basal Cell carcinoma) * Complete blood count, differential and platelet count must be within normal limits (WNL) or verified by the study chair to be related to conditions not interfering with normal health status * Adequate hepatic and renal function (these must be WNL or verified by study chair to be related to conditions not interfering with normal health status) * Normal fasting glucose * No history of diabetes * Medically and Psychologically able to comply with all study requirements * Accessible to Follow up Exclusion Criteria * Less than 21 years of age * Known invasive breast cancer of any type * Bilateral prophylactic mastectomy * Prior malignancy of any type that occurred less than 5 years previously, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Existing non-malignant disease that would preclude the administration of SOM230 * Pregnancy: All subjects will have a beta human chorionic gonadotropin (b-hCG) serum pregnancy test to rule out pregnancy, a history will also be taken to make certain that recent sexual exposure does not put them at risk for pregnancy. If so a second serum pregnancy test will be done. Volunteers will be asked to use barrier contraception during study. * Tamoxifen or other preventive measures within 6 months * Serious Psychiatric condition or addictive disorder * Diabetes or elevated fasting blood sugar * Inability to inject medication or test for finger stick glucose * Symptomatic gallstones or known gall bladder disease * History of cholecystitis without cholecystectomy * Electrolyte abnormalities (particularly hypokalemia or hypomagnesemia) QT related exclusion criteria * QTcF at screening \> 450 msec. * History of syncope or family history of idiopathic sudden death. * Sustained or clinically significant cardiac arrhythmias. * Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block. * Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure * Concomitant medication(s) known to increase the QT interval.