drugset / Trial / NCT00977379

A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis

NCT00977379 ↗

Phase 2 Terminated 24 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.

Timeline

Start
2009-08
Primary completion
2011-02
Completion
2011-02

Outcome

Outcome not reported

Stopped (Enrollment): “Due to an insufficient number of participants enrolled.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral

Indications