Inclusion Criteria

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.