NCT00075413

Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer

A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	arsenic trioxide

Timeline

• Start date: 2002-11-01
• Primary completion: 2005-07-01
• First posted: 2004-01-12
• Last updated: 2015-10-02