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Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial


Phase 1
21 Years
N/A
Not Enrolling
Female
Atypical Ductal Breast Hyperplasia,, Lobular Carcinoma in Situ (LCIS),, Atypical Lobular Hyperplasia (ALH) of Breast

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Trial Information

Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial

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.

Type of Study:

Interventional

Study Design:

N/A

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).

Safety Issue:

No

Principal Investigator

David L Kleinberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

R6-937

NCT ID:

NCT01372644

Start Date:

Completion Date:

Related Keywords:

  • Atypical Ductal Breast Hyperplasia,
  • Lobular Carcinoma in Situ (LCIS),
  • Atypical Lobular Hyperplasia (ALH) of Breast
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Hyperplasia
  • Carcinoma, Lobular

Name

Location

NYU School of MedicineNew York, New York  10016