We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372644
First Posted: June 14, 2011
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The investigators have previously shown insulin-like growth factor-I (IGF-I) is required to permit estrogen (E2) and progesterone action in the mammary gland, and that a novel somatostatin analog, SOM230, that inhibits IGF-I action can prevent E2 action on the mammary gland. It reduces cell proliferation and increases apoptosis (cell death) in the rat mammary gland. This study was designed to determine whether women at high risk for breast cancer respond to SOM230 in the same way that rats do. Methods: Women with atypical ductal hyperplasia or lobular carcinoma in-situ by core biopsy were treated for 9.5 days with SOM230 (600mcg BID). Surgical excision was performed on day 10. Sections were examined before and after SOM230 treatment for cell proliferation (Ki67) and apoptosis (TUNEL). Serum IGF-I, fasting glucose, insulin, and HbA1C were measured in anticipation of changes.

Condition Intervention Phase
Atypical Ductal Breast Hyperplasia Lobular Carcinoma in Situ (LCIS) Atypical Lobular Hyperplasia (ALH) of Breast Drug: SOM 230 / Pasireotide Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Cell Proliferation and apoptosis [ Time Frame: 10 days ]
    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).


Enrollment: 15
Study Start Date: November 2007
Study Completion Date: November 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADH, ALH, LCIS, SOM 230
Women who meet eligibility criteria.
Drug: SOM 230 / Pasireotide

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372644


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
United States Department of Defense
Investigators
Principal Investigator: David L Kleinberg, MD NYU School of Medicine
Study Director: Julia Smith, MD NYU School of Medicine
Study Director: Deborah Axelrod, MD NYU School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01372644     History of Changes
Other Study ID Numbers: R6-937
BC061512 ( Other Grant/Funding Number: Department of Defense )
First Submitted: June 9, 2011
First Posted: June 14, 2011
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hyperplasia
Carcinoma in Situ
Carcinoma, Lobular
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Pathologic Processes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs