NCT00896376

Trastuzumab in Treating Women With Metastatic Breast Cancer

Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	trastuzumab
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-12-01
• Completion: 2010-09-01
• First posted: 2009-05-11
• Last updated: 2015-02-10

Locations

1 site across 1 country: France