drugset / Trial / NCT00520975

Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU

NCT00520975

Phase 3 Terminated 96 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupTriple-blindTreatment

Summary

This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.

Timeline

Start
2007-11
Primary completion
2015-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody Intravenous
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous
Background Trastuzumab Monoclonal antibody Intravenous

Indications