Breast Cancer Clinical Trial
Official title:
Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well epothilone B works in treating patients
with CNS metastases from breast cancer.
OBJECTIVES:
Primary
- Determine the 3-month CNS-progression free survival of patients with CNS metastases
secondary to breast cancer treated with epothilone B.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the CNS response rate and duration of CNS response in patients treated with
this drug.
- Determine the systemic disease response rate and duration of systemic response in
patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive epothilone B IV over 20 minutes on day 1. Courses repeat every 21 days in
the absence of disease progression, satisfactory response, or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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