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Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Recurrent Breast Carcinoma Clinical Trial

Official title:
Phase II Trial of CCI-779 (Temsirolimus) in Patients With Locally Advanced or Metastatic Breast Cancer

Clinical Trial Summary

This phase II trial studies how well temsirolimus works in treating patients with breast cancer that has spread to other places in the body. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To 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. To compare the activity of temsirolimus in patients with locally advanced or metastatic breast cancer whose primary tumors have mutations in the PIK3CA or 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.

OUTLINE:

Patients receive temsirolimus intravenously (IV) over 30 minutes weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00376688
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date July 11, 2006
Completion date December 16, 2019
View Details
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