Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Other	UTMB-02403 NCT00075413

Objectives

Primary

1. Determine the safety and activity of arsenic trioxide in women with locally advanced or metastatic breast cancer.
2. Determine the qualitative and quantitative toxic effects of this drug in these patients.

Secondary

1. Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
2. Determine the patterns of failure and survival in patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 14-30 patients will be accrued for this study within 9-24 months.

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.

Trial Contact Information

Trial Lead Organizations

University of Texas Medical Branch

Dennie Jones, MD, Protocol chair(Contact information may not be current)		Ph: 409-772-1165

Registry Information
Official Title		A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
Trial Start Date		2002-11-15
Trial Completion Date		2005-07-15
Registered in ClinicalTrials.gov		NCT00075413
Date Submitted to PDQ		2003-11-13
Information Last Verified		2006-04-26

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