Phase II Trial of CCI-779 (Temsirolimus) in Patients With Locally Advanced or Metastatic Breast Cancer
I. Determine the overall activity (complete response, partial response, and stable disease)
of temsirolimus in patients with recurrent locally advanced or metastatic breast cancer.
II. Compare the activity of temsirolimus in patients whose primary tumors have mutations in
the PIK3CA or PTEN gene with those whose tumors do not have a mutation in the PIK3CA
gene.Correlate the antitumor activity of temsirolimus with alterations in expression of
genes in the PI3K pathway in primary tumor biopsy specimens.
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats
every 28 days in the absence of disease progression or unacceptable toxicity.
Tissue collected from the primary tumor is examined by gene sequencing and
immunohistochemistry for gene mutations and protein expression in the PI3K pathway,
including PIK3CA and PTEN mutations. Fluorescent in situ hybridization (FISH) is used to
detect alterations in PIK3CA gene copy number. Immunohistochemical staining is used for
cyclin D1, PTEN, pAKT, SGK-1, p-mTOR, pE-BP1, and phospho and total S6 kinase.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall activity (complete response, partial response, and stable disease) of temsirolimus
Up to 24 months
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|