arsenic trioxide in treating women with locally advanced or metastatic breast cancer

Conditions: Breast Cancer

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.

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.

Eligibility criteria:
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

Keywords: stage iiib breast cancer stage iiic breast cancer stage iv breast cancer recurrent breast cancer stage iiia breast cancer