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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer, meeting 1 of the following criteria: Locally advanced disease Cannot be adequately treated by radiotherapy or surgery Metastatic disease Ineligible for OR received prior anthracycline- and/or taxane-based chemotherapy with subsequent disease progression No uncontrolled Central Nervous System (CNS) metastases Ineligible for treatment protocols of higher priority Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 OR Southwest Oncology Group (SWOG) 0-1 OR Zubrod 0-1 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times normal Serum Glutamic Oxalacetic Transaminase (SGOT)/Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times normal Renal Creatinine no greater than 2.0 mg/dL Calcium no greater than 12 mg/dL Cardiovascular Cardiac ejection fraction greater than 50% No myocardial infarction or ischemia within the past 6 months No uncontrolled clinically significant dysrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Electrolytes normal Magnesium normal No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No prior or ongoing grade 2-4 peripheral neuropathy No comorbid condition that would render the patient at high risk from study treatment complications PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent cytokine therapy Chemotherapy See Disease Characteristics No more than 3 prior chemotherapy regimens for breast cancer No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 2 weeks since prior radiotherapy No prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion No concurrent radiotherapy except for the following: Palliative or emergent radiotherapy Local consolidative radiotherapy Surgery More than 2 weeks since prior surgery Concurrent local consolidative surgery allowed Other At least 4 weeks since prior antineoplastic agents for nonmalignant conditions (e.g., methotrexate for rheumatoid arthritis) No concurrent antineoplastic agents for nonmalignant conditions No concurrent participation in another treatment protocol Concurrent local palliative therapy allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arsenic trioxide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer