Skip to content

Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

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

NCTNCT01372618 (opens ClinicalTrials.gov in a new tab)Other id10-00641Other idBC097854

Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
9 participants (actual)
Sponsor
NYU Langone Health · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2011
Primary completion
Oct 2015
Completion
Oct 2015
First posted
14 Jun 2011 (estimated)
Last update posted
27 Dec 2017
Conditions
Ductal Carcinoma in Situ

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. Ph 1/2

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

    NCT01372618

    Jun 2011 to Oct 2015

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230) in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in reducing the occurrence of invasive breast cancer. Unfortunately, treatment with antiestrogens carries potential serious side effects and toxicities that are intolerable to some patients. Preliminary data suggest that inhibition of IGF-1 action in the breast will be at least as effective as tamoxifen. Pasireotide is a somatostatin analog that prevents mammary development by inhibiting IGF-1 action directly in the mammary gland and also indirectly without causing menopausal symptoms. This study is an expansion of work that we have previously done in women with atypical hyperplasia of the breast, which showed that treatment with pasireotide for 10 days caused a reduction in the cellularity of these precancerous lesions. In our present study, women with DCIS will be treated with pasireotide for 20 days prior to surgical excision. Endpoints will be as follows: 1. To determine whether pasireotide will inhibit cell proliferation and angiogenesis (signs of tumor growth), and stimulate apoptosis (cell death) in surgically excised tissue in comparison to core biopsies from women with estrogen receptor (ER) positive DCIS. Both the core biopsy and surgical excision are standard of care procedures that women with DCIS have regardless of participation in this trial. 2. To use dynamic contrast enhanced MRI to assess patients before and after treatment with pasireotide and evaluate for changes in tumor volume and other tumor related features 3. In our previous study we found that many women experienced a slight elevation in blood sugar with 10 days of treatment with pasireotide. Other work has shown that this effect often resolves with greater duration of treatment. We are therefore expanding the duration of treatment in this study to 20 days to assess if the initial hyperglycemia seen with pasireotide improves as treatment duration progresses.

Interventions

  • SOM 230 / PasireotideDrug

Arms1

  • Experimental

    SOM 230/Pasireotide

    Treatment with SOM230 600mcg twice daily for 20 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cell Proliferation and Apoptosis

    Time frame · Before and after 20 days of treatment

    Registry 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).

Secondary outcomes(2)
  1. Effect of SOM 230 / Pasireotide on Tumor Volume and Tumor Kinetics

    Time frame · Before and after 20 days of treatment

    Registry description

    To determine whether pasireotide prevents angiogenesis in DCIS as it does in the rat mammary gland, we will immunostain tissue samples for Factor VIII to identify vessels in DCIS before and after treatment. Further, using dynamic contrast enhanced MRI (DCE-MRI) we plan to detect changes in angiogenesis in vivo, non-invasively, and also detect effects of pasireotide which theoretically should inhibit vascularity. We propose to evaluate changes in the size of the lesion, changes in the morphologic appearance and kinetic features of the lesion.

  2. Hyperglycemia

    Time frame · Before and after 20 days of treatment with 3 month post-treatment follow-up

    Registry description

    In our previous study, we found that women had moderately increased blood sugar early after starting SOM230. In other studies in normal individuals this effect disappeared by a week or two. We found some evidence of improvement during administration. However, extending the treatment period from 9.5 to 19.5 days will enable us to make certain that the early elevated sugar associated with SOM230 is only temporary.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Before and after 20 days of treatment

Cell Proliferation and Apoptosis

GroupValue
SOM 230/Pasireotidenot posted
Secondary and other outcome results(2)
Secondary outcome· Before and after 20 days of treatment

Effect of SOM 230 / Pasireotide on Tumor Volume and Tumor Kinetics

GroupValue
SOM 230/Pasireotidenot posted
Secondary outcome· Before and after 20 days of treatment with 3 month post-treatment follow-up

Hyperglycemia

GroupValue
SOM 230/Pasireotidenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SOM 230/PasireotideTreatment with SOM230 600mcg twice daily for 20 days. SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously.0 / 90 / 90 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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 handicap * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.