Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Centre Antoine Lacassagne
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Toxicity, including cardiotoxicity and immuno-allergic reactions
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer. Secondary * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Toxicity, including cardiotoxicity and immuno-allergic reactions
Time Frame: 1 year
Clinical response as assessed by RECIST criteria
Time Frame: 1 year