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Keep this study
Lead
Institut Curie
OBJECTIVES:
Primary
* Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.
Secondary
* Evaluate the tolerability.
* Compare the duration of response.
* Compare local progression-free survival.
* Compare overall survival.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
* Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
