Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer

OBJECTIVES: * Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate alone, in terms of objective tumor response, in women with advanced breast cancer. * Compare the adverse effects of and tolerance to these regimens in these patients. OUTLINE: This is a randomized study. * Arm I: Patients receive gradually escalating doses of oral antineoplaston A10 capsules 7 times daily until the maximum tolerated dose is reached, followed by oral methotrexate capsules 2 to 3 times per day in five days on and five days off courses. Treatment continues in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral methotrexate alone on the same schedule as in arm I. Tumors are measured every 4 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6. PROJECTED ACCRUAL: A total of 30-70 patients will be accrued for this study within at least 12 months.