Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor
Status:
Terminated
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health