Breast Cancer Clinical Trial
Official title:
Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. It is not yet known
whether radiation therapy is more effective when given alone or together with temozolomide
in treating brain metastases secondary to breast cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy given
together with temozolomide works compared with radiation therapy given alone in treating
women with brain metastases and breast cancer.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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