drugset / Trial / NCT01275677

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

NCT01275677

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.

Timeline

Start
2011-02-08
Primary completion
2017-07-31
Completion
2025-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Docetaxel Small molecule Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Paclitaxel Small molecule Intravenous