A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
- 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
- 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
Primary Purpose: Treatment
Dennie V. Jones, MD
University of Texas
United States: Federal Government