Trastuzumab in Treating Women With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00896376|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : February 10, 2015
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: trastuzumab Other: laboratory biomarker analysis Other: pharmacological study||Not Applicable|
- To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer.
- To analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival).
OUTLINE: This is a multicenter study.
Patients receive standard treatment with trastuzumab. Blood is collected periodically for pharmacogenetic analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||September 2010|
|Experimental: trastuzumab||Biological: trastuzumab Other: laboratory biomarker analysis Other: pharmacological study|
- Toxicity, including cardiotoxicity and immuno-allergic reactions [ Time Frame: 1 year ]
- Clinical response as assessed by RECIST criteria [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896376
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Study Chair:||Jean Marc Ferrero, MD||Centre Antoine Lacassagne|