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: Phase II trial to study the effectiveness of arsenic trioxide in treating women who have locally advanced or metastatic breast cancer.

Condition	Treatment or Intervention	Phase
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer stage IIIA breast cancer	Drug: arsenic trioxide  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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

• ECOG 0-1 OR
• 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
• SGOT/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

Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States; Recruiting

Study chairs or principal investigators

Dennie V. Jones, MD,  Study Chair,  University of Texas   

Study ID Numbers:  CDR0000346365; UTMB-02403; NCT00075413
Record last reviewed:  December 2003
Last Updated:  December 6, 2004
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075413
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08