- 21 years of age and older
- Must sign informed consent, witnessed, and dated prior to entry
- The participant has breast biopsy consistent with Ductal Carcinoma in situ (DCIS)
- 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 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 for 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 pasireotide
- Pregnancy: All subjects will have a beta-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 either by history or by HgbA1c greater than
6.5% or fasting serum glucose greater than 100mg/dL on screening labs. If fasting
serum glucose is greater than 100mg/dL on screening labs, this test will be repeated
to confirm the results
- Inability to inject medication or test for finger stick glucose
- Gall bladder disease
- History of cholecystitis without cholecystectomy
- Electrolyte abnormalities (particularly hypokalemia or hypomagnesemia)
- Contraindication for MRI
- If tumor size is < 1cm on mammography and all calcifications are removed on core
biopsy the patient will be excluded.
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.
Hepatic Related Exclusion Criteria
- Baseline Alanine transaminase (ALT) or Aspartate transaminase (AST) > 2x upper limit
of normal (ULN) without known complications of metastatic liver disease or primary
hepatic disease (e.g. Cushing's disease and Acromegaly studies).
- Baseline Total Bilirubin > 1.5x ULN