Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of breast cancer
• •* Unresectable disease or patient refused surgery
• •Must have brain metastases
• •PATIENT CHARACTERISTICS:
• •WHO performance status 0-2
• •ANC ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Liver transaminases ≤ 1.5 times upper limit of normal (ULN)
• •Creatinine \< 1.5 times ULN
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No carcinomatous meningitis
• •No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
• •No other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment
• •No contraindications to treatment with temozolomide
• •No psychological, familial, social, or geographic situations that preclude clinical follow up
• •No patient deprived of liberty or under guardianship
• •PRIOR CONCURRENT THERAPY:
• •No prior brain radiotherapy
• •At least 10 days since prior chemotherapy