And AS2-1 In Patients With Carcinoma Of The Breast Study the safety and possible effectiveness of antineoplastons in incurable carcinoma of the breast. Describe the patients' response, tolerance to, and the side effects of this regimen. There will be no exclusion based on tumor size or systemic metastases. The minimum size of the lesion to be considered malignant and measurable should be more than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and not less than 0.5 cm in the largest diameter for the other localizations. Small lesions, 0.5 to 2 cm in diameter which cannot be accurately measured on scans should be excluded from evaluation, but they should be included if they can be measured accurately.
Patients are female.
The patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. The patients must be 18 years of age or older. Patient must sign the Informed Consent Form indicating an awareness of the experimental nature of this study. Patient must fully recover from the operative procedure and have life expectancy of two months or more.