Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast|
|Study Start Date:||November 2002|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- Determine the safety and activity of arsenic trioxide in women with locally advanced or metastatic breast cancer.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
- Determine the patterns of failure and survival in patients treated with this drug.
OUTLINE: This is a pilot study.
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (for course 1 only). Beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days 1 and 5 of weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who have a complete response (CR) receive an additional course beyond documentation of CR. Patients who have a CR due to local consolidative therapy (e.g., surgery or radiotherapy) receive an additional 2 courses beyond CR.
Patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 9-24 months.