A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression

A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy

This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Inclusion Criteria:

• female patients, >=18 years of age;
• breast cancer;
• CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
• at least one measurable lesion;
• ECOG performance status 0-2.

Exclusion Criteria:

• prior systemic treatment of brain metastases;
• prior disease progression while on Xeloda treatment;
• previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
• clinically significant cardiovascular disease.