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.