Cell Proliferation and Apoptosis
| Group | Value |
|---|---|
| SOM 230/Pasireotide | not posted |
Trial · Interventional
TerminatedPhase 1/2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: PI has passed away. Requested by department to terminate study.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
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.
Experimental
SOM 230/Pasireotide
Treatment with SOM230 600mcg twice daily for 20 days.
Outcomes the sponsor listed as primary.
Cell Proliferation and Apoptosis
Time frame · Before and after 20 days of treatment
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).
Effect of SOM 230 / Pasireotide on Tumor Volume and Tumor Kinetics
Time frame · Before and after 20 days of treatment
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.
Hyperglycemia
Time frame · Before and after 20 days of treatment with 3 month post-treatment follow-up
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| SOM 230/Pasireotide | not posted |
| Group | Value |
|---|---|
| SOM 230/Pasireotide | not posted |
| Group | Value |
|---|---|
| SOM 230/Pasireotide | not posted |
| Group | Deaths | Serious events | Other 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 / 9 | 0 / 9 | 0 / 9 |
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