Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial
- 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
- 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
- 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
- Concomitant medication(s) known to increase the QT interval.