Trastuzumab in Treating Women With Metastatic Breast Cancer
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.
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer|
- Toxicity, including cardiotoxicity and immuno-allergic reactions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Clinical response as assessed by RECIST criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||September 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: trastuzumab||Biological: trastuzumab Other: laboratory biomarker analysis Other: pharmacological study|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896376
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Study Chair:||Jean Marc Ferrero, MD||Centre Antoine Lacassagne|