NCT00875355

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

Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	temozolomide	Given orally
RADIATION	radiation therapy	Patients undergo radiotherapy

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-11-01
• First posted: 2009-04-03
• Last updated: 2009-08-26

Locations

1 site across 1 country: France