drugset / Trial / NCT01724606

Whole Brain Radiotherapy (WBRT) With Sorafenib for Breast Cancer Brain Metastases (BCBM)

NCT01724606 ↗

NaSingle-groupOpen-labelTreatment

Summary

Sorafenib is a new type of anti-cancer drug. It belongs to a new class of medications known as tyrosine kinase inhibitors. Sorafenib is thought to work against cancer in many ways. It helps decrease blood supply to the tumor. It also blocks some proteins that help the tumor cells to grow." Sorafenib is approved by the Food and Drug administration (FDA) for treatment for other cancers like liver and kidney cancer. Sorafenib has also been studied in the treatment of breast cancer that has spread but is not specifically approved for the treatment of breast cancer. It has been studied both as a single agent and also in combination with other anti-cancer therapies for breast cancer. In laboratory models and in some patients with other cancers, sorafenib has been studied in tumors in the brain. In this study, sorafenib will be given together with whole brain radiation therapy (WBRT). Overall this research study is designed to answer 2 main questions: 1. What dose of sorafenib should be used together with WBRT? 2. What are the side effects of sorafenib and WBRT when given together?

Timeline

Start
2012-11-05
Primary completion
2022-03-01
Completion
2022-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 200 mg Oral
Subject Sorafenib Small molecule 400 mg Oral
Subject Sorafenib Small molecule 600 mg Oral