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