Status: Recruiting

Official Title: XERAD: Open-label, phase II, randomized, comparative, multicentre trial of concurrent Whole Brain Radiation Therapy (WBRT) and capecitabine (Xeloda® ) followed by maintenance capecitabine compared with standard WBRT in breast cancer patients with newly diagnosed brain metastasis

Brief Summary: This open-label, randomized, parallel arm study will evaluate the effect of Xeloda administered concurrently with Whole Brain Radiation Therapy (WBRT) and as maintenance therapy in patients with breast cancer and newly diagnosed brain metastases. Patients will be randomized to receive either Xeloda (825 mg/sqm orally bid) on days 1-14 of the 1st 3-week cycle together with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with Xeloda (1000 mg/sqm orally bid) on days 1-14 from cycle 2 onwards, or another systemic therapy in the WBRT only group. The anticipated time on study treatment is until disease progression and the target sample size is <150.

Study Phase: 2

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

• women >/= 18 years of age
• histologically confirmed breast cancer with known HER2 and hormone status
• newly diagnosed CNS metastasis with at least one measurable (>/=0.5cm) lesion
• patient not eligible or refusing surgery or stereotactic radiosurgery
• EOCG performance status 0-2

• prior treatment of brain metastases
• prior disease progression or appearance of brain metastases while on treatment with capecitabine
• leptomeningeal disease
• known contra-indication to radiotherapy or MRI or capecitabine

This trial will be conducted at the following locations:

• BOBIGNY 93000
• PARIS
• DIJON
• ROUEN
• BEZIERS
• PARIS
• LILLE
• PARIS
• NANTES
• LYON
• LE MANS
• SALOUEL
• NARBONNE
• MONTPELLIER
• ARRAS
• NICE
• MARSEILLE
• ROUEN