Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating women with stage IV breast cancer that has not responded to standard therapy.

OBJECTIVES: * Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response. * Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day. Treatment continues for at least 6 weeks. Patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.