drugset / Trial / NCT00003440

Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic

NCT00003440

Phase 3 Completed 580 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.

Timeline

Start
1998-07
Primary completion
2004-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule Intravenous
Subject Trastuzumab Monoclonal antibody Intravenous