drugset / Trial / NCT00544167

Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer

NCT00544167

NaSingle-groupOpen-labelTreatment

Summary

Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard chemotherapy in the treatment of early stage node positive or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for patients, this would provide rationale for further studies in a larger randomized fashion.

Timeline

Start
2007-05
Primary completion
2008-01
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 400 mg Oral
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous

Indications