Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
18 Years
N/A
Female
Breast Cancer, Metastatic Cancer
Trial Information
Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Response at 6 weeks as assessed by MRI and/or scan
Safety Issue:
No
Principal Investigator
Youlia Kirova
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Curie
Authority:
Unspecified
Study ID:
CDR0000633496
NCT ID:
NCT00875355
Start Date:
November 2007
Completion Date:
Related Keywords:
- Breast Cancer
- Metastatic Cancer
- tumors metastatic to brain
- stage IV breast cancer
- Breast Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
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