Tipifarnib Plus Tamoxifen in Treating Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of metastatic (stage IV) breast cancer
• Evidence of disease progression
• Measurable disease
• Must have been previously treated with at least 1 hormonal therapy with either an aromatase inhibitor or an estrogen receptor (ER)-modulating drug in the adjuvant or metastatic setting and meets 1 of the following criteria:
• * Hormone-responsive disease:
• * Stable disease (no recurrence or progression for at least 6 months)
• * Objective response
• * Hormone-nonresponsive disease:
• * No stable disease
• * No objective response
• Previously treated CNS disease allowed provided patient has a life expectancy of at least 3 months (phase I patients) (Phase I closed to accrual effective 10/23/2003)
• No CNS metastases (phase II patients)
• Hormone receptor status:
• * ER and/or progesterone receptor positive
• NOTE: As few as 1% positive cells considered positive
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• Zubrod 0-1
• Life expectancy
• See Disease Characteristics
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic
• Bilirubin no greater than 2.0 mg/dL (unless evidence of Gilbert's disease)
• SGOT and SGPT less than 3 times upper limit of normal (unless liver involvement by tumor)
• Renal
• Creatinine no greater than 1.5 mg/dL
• Other
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception during and for 2 months after study participation
• No medical or psychiatric condition that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• No more than 2 prior chemotherapy regimens for metastatic disease (phase II patients)
• * No limitations on prior neoadjuvant or adjuvant regimens
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• Endocrine therapy
• See Disease Characteristics
• At least 6 months since prior tamoxifen
• Concurrent stable dose of steroids allowed (phase I patients) (Phase I closed to accrual effective 10/23/2003)
• Radiotherapy
• No concurrent radiotherapy
• Surgery
• Concurrent surgery allowed provided the need for surgery is not due to disease progression
• Other
• Recovered from all prior therapy
• No prior warfarin
• No concurrent cytochrome p450-inducing anti-convulsants
• No other concurrent anticancer therapies
• Concurrent bisphosphonates for bone metastases allowed