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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00227656
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pegylated interferon alfa-2a may interfere with the growth of tumor cells. Giving capecitabine together with pegylated interferon alfa-2a may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with pegylated interferon alfa-2a works in treating patients with recurrent or progressive brain metastases due to breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the efficacy of capecitabine and pegylated interferon alfa-2a, in terms of 6-month neurologic progression-free rate, in patients with recurrent or progressive brain metastases secondary to breast cancer.
Secondary
* Determine the toxicity spectrum of this regimen in these patients.
* Determine the time to neurologic progression and overall survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral capecitabine twice daily on days 1-14 and pegylated interferon alfa-2a subcutaneously on days 1, 8, and 15. Treatment repeats every 3 weeks for at least 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 38-98 patients will be accrued for this study within 2 years.
Study:
NCT00227656
Study Brief:
Protocol Section:
NCT00227656