Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Personal history of stage Tis, I, II, or IIIA breast cancer
• Previously treated with definitive resection with curative intent
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• Over 18
• Sex:
• Female
• Menopausal status:
• Not specified
• Performance status:
• ECOG 0-1
• Life expectancy:
• Not specified
• Hematopoietic:
• WBC at least 3,000/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin at least 9.0 g/dL
• Hepatic:
• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 1.5 times ULN
• Renal:
• Creatinine no greater than 1.6 mg/dL
• Other:
• No known malabsorption syndrome
• No contraindication to perillyl alcohol
• No hypersensitivity to citrus or soybean products
• No non-breast malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ
• No active malignancy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• At least 6 months since prior chemotherapy
• Endocrine therapy:
• Concurrent adjuvant hormonal therapy allowed
• Radiotherapy:
• At least 6 months since prior radiotherapy
• Surgery:
• See Disease Characteristics
• At least 6 months since prior surgery
• At least 2 years since prior primary surgery
• More than 4 weeks since prior surgery requiring general anesthesia, including breast reconstructive surgery
• Other:
• More than 3 months since prior enrollment in a single-dose study of perillyl alcohol
• More than 3 months since prior enrollment in current study (at a lower dose level)
• No concurrent vitamin supplements except a daily multivitamin (recommended daily allowance)