Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00376688|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2006
Results First Posted : May 26, 2014
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor Positive HER2/Neu Positive Male Breast Carcinoma Progesterone Receptor Positive Recurrent Breast Carcinoma Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7||Other: Laboratory Biomarker Analysis Drug: Temsirolimus||Phase 2|
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 phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) or phosphatase and tensin homolog (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.
Patients receive temsirolimus intravenously (IV) over 30 minutes weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of CCI-779 (Temsirolimus) in Patients With Locally Advanced or Metastatic Breast Cancer|
|Actual Study Start Date :||July 11, 2006|
|Actual Primary Completion Date :||June 12, 2008|
U.S. FDA Resources
Experimental: Treatment (temsirolimus)
Patients receive temsirolimus IV over 30 minutes weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Temsirolimus
- Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease) [ Time Frame: Up to 24 months ]
Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.
Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;
Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376688
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Gini Fleming||University of Chicago Comprehensive Cancer Center|