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Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor

Phase 2
21 Years
Open (Enrolling)
Ductal Carcinoma in Situ

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Trial Information

Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor

Inclusion Criteria:

- 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

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 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
cardiac failure

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cell proliferation and apoptosis

Outcome Description:

Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).

Outcome Time Frame:

Before and after 20 days of treatment

Safety Issue:


Principal Investigator

David L Kleinberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Ductal Carcinoma In Situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



NYU School of Medicine New York, New York  10016