Trastuzumab in Treating Women With Metastatic Breast Cancer
Recruitment status was Recruiting
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:||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 [ Designated as safety issue: Yes ]
- Clinical response as assessed by RECIST criteria [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- 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.
|Centre Antoine Lacassagne||Recruiting|
|Nice, France, 06189|
|Contact: Jean Marc Ferrero, MD 33-4-9203-1114 email@example.com|
|Investigator:||Jean Marc Ferrero, MD||Centre Antoine Lacassagne|