Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00376688 |
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with recurrent locally advanced or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: temsirolimus Procedure: cytogenetic analysis Procedure: fluorescence in situ hybridization Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: molecular genetic technique Procedure: mutation analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of CCI-779 (Temsirolimus) in Patients With Locally Advanced or Metastatic Breast Cancer |
Estimated Enrollment: | 58 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Tissue collected from the primary tumor is examined by gene sequencing and immunohistochemistry for gene mutations and protein expression in the PI3K pathway, including PIK3CA and PTEN mutations. Fluorescent in situ hybridization (FISH) is used to detect alterations in PIK3CA gene copy number. Immunohistochemical staining is used for cyclin D1, PTEN, pAKT, SGK-1, p-mTOR, pE-BP1, and phospho and total S6 kinase.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Either the primary or metastatic tumor must meet ≥ 1 of the following criteria:
Brain metastases allowed provided all of the following criteria are met:
PATIENT CHARACTERISTICS:
No uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 |
Study Chair: | Gini F. Fleming, MD | University of Chicago |
Study ID Numbers: | CDR0000495399, UCCRC-14705A, NCI-7674 |
Study First Received: | September 13, 2006 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00376688 |
Health Authority: | United States: Food and Drug Administration |
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer stage IV breast cancer male breast cancer |
Skin Diseases Breast Neoplasms, Male Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |