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Spots Global Cancer Trial Database for Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

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

Study ID: NCT00376688

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Contact Details

Name: Gini F Fleming

Affiliation: University of Chicago Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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