Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00450866
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00450866
Study Brief:
Protocol Section:
NCT00450866