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

Phase 1

Completed

• Conditions: Atypical Ductal Breast Hyperplasia; Atypical Lobular Hyperplasia (ALH) of Breast; Lobular Carcinoma in Situ (LCIS)
• Interventions: Drug: SOM 230 / Pasireotide

• Registration Number: NCT01372644
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-12
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-14
• Study Completion: 2013-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADH, ALH, LCIS, SOM 230	SOM 230 / Pasireotide	Women who meet eligibility criteria.

Primary Outcome Measures

Name	Time	Method
Cell Proliferation and apoptosis	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).

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States