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

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)