drugset / Trial / NCT00033514

Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression

NCT00033514

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

Timeline

Start
2001-08
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 50 mg Oral
Subject Erlotinib Small molecule 100 mg Oral
Subject Erlotinib Small molecule 150 mg Oral
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications