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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: temozolomide
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks. | Radiation: radiation therapy<br>* Patients undergo radiotherapy<br>|
| Experimental: Arm II<br>Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks. | Drug: temozolomide<br>* Given orally<br>Radiation: radiation therapy<br>* Patients undergo radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response at 6 weeks as assessed by MRI and/or scan |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumors metastatic to brain, stage IV breast cancer