Temsirolimus in Treating Patients With Recurrent Locally Advanced or Metastatic Breast Cancer
This phase II trial studies how well temsirolimus works in treating patients with recurrent locally advanced or metastatic breast cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of CCI-779 (Temsirolimus) in Patients With Locally Advanced or Metastatic Breast Cancer|
- Overall activity (complete response, partial response, and stable disease) of temsirolimus [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]Will be correlated with marker expression using Fisher's exact test.
|Study Start Date:||July 2006|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: Treatment (temsirolimus)
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
I. Determine the overall activity (as defined by complete response [CR] + partial response [PR] + stable disease [SD] for >= 24 weeks) of a weekly 25 mg intravenous dose of temsirolimus in patients with locally advanced or metastatic breast cancer.
II. Compare the activity of temsirolimus in patients with locally advanced or metastatic breast cancer whose primary tumors have mutations in the phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) or phosphatase and tensin homolog (PTEN) gene with those whose tumors do not have a mutation in the PIK3CA gene.
III. To examine correlations between antitumor activity of temsirolimus and alterations in expression of genes in the PI3K pathway in primary tumor biopsy specimens.
Patients receive temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Gini Fleming||University of Chicago Comprehensive Cancer Center|