drugset / Trial / NCT01131195

Metronomic Therapy in Metastatic Breast Cancer.

NCT01131195 ↗

Phase 3 Completed 139 enrolled Swiss Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor 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. Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bevacizumab is more effective when given together with paclitaxel or cyclophosphamide and capecitabine in treating patients with breast cancer. PURPOSE: This randomized phase III trial is studying the side effects of giving bevacizumab together with paclitaxel and to see how well it works compared with giving bevacizumab together with cyclophosphamide and capecitabine as first-line therapy in treating women with locally advanced, recurrent, or metastatic breast cancer.

Timeline

Start
2010-07-19
Primary completion
2012-12-14
Completion
2018-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Comparator Capecitabine Small molecule 500 mg Oral
Comparator Cyclophosphamide Other / unclassified 50 mg Oral
Comparator Paclitaxel Small molecule 90 mg/m2 Intravenous

Indications