Clinical Trials Directory

Trials / Completed

CompletedNCT00376688

Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
31 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGTemsirolimusGiven IV

Timeline

Start date
2006-07-11
Primary completion
2008-06-12
Completion
2019-12-16
First posted
2006-09-15
Last updated
2020-02-24
Results posted
2014-05-26

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00376688. Inclusion in this directory is not an endorsement.