Status:
UNKNOWN
Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
Lead Sponsor:
Institut Curie
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
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 * E...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00875355
Start Date
November 1 2007
Last Update
August 26 2009
Active Locations (1)
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1
Institut Curie Hopital
Paris, France, 75248