Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
- Compare the objective response rate at 6 weeks in women with brain metastases secondary
to breast cancer treated with radiotherapy with vs without temozolomide.
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Response at 6 weeks as assessed by MRI and/or scan