Breast Cancer, Metastatic Cancer
Conditions
Keywords
tumors metastatic to brain, stage IV breast cancer
Brief 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.
Interventions
DRUGtemozolomide
Given orally
RADIATIONradiation therapy
Patients undergo radiotherapy
Sponsors
Institut Curie
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response at 6 weeks as assessed by MRI and/or scan | — |
Countries
France
Outcome results
None listed