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

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Women with histologically confirmed breast cancer with known human epidermal receptor-2 (HER2) and hormone status

• Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than or equal to (>/=) 1 centimeter (cm) or two lesions measuring >/= 0.5 to less than (<) 1 cm in longest dimension

• Participant not eligible for or refusing surgery or stereotactic radiosurgery

• Eastern cooperative oncology group (EOCG) performance status 0 to 2

Exclusion Criteria:

• Prior treatment of brain metastases

• Leptomeningeal disease

• Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or capecitabine