Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast
• * Locally advanced or metastatic disease
• * Incurable disease
• Tumor accessible for biopsy
• Prior breast cancer allowed
• No symptomatic or untreated brain metastases or carcinomatous meningitis
• * Neurologically stable patients with inactive brain metastases are allowed if off corticosteroids for at least 4 weeks prior to study
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Sex:
• Male or female
• Menopausal status:
• Not specified
• Performance status:
• ECOG 0-2
• Life expectancy:
• At least 3 months
• Hematopoietic:
• Granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin normal
• ALT/AST no greater than 2.5 times upper limit of normal
• Renal:
• Creatinine normal OR
• Creatinine clearance at least 60 mL/min
• Cardiovascular:
• LVEF at least 40%
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Ophthalmic:
• No prior abnormalities of the cornea, including:
• * Dry eye syndrome or Sjogren's syndrome
• * Congenital abnormality (e.g., Fuch's dystrophy)
• * Abnormal slit-lamp examination with a vital dye (e.g., fluorescein or Bengal-Rose)
• * Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
• No concurrent use of contact lenses
• Other:
• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (e.g., gefitinib or other anilinoquinazolines)
• No other concurrent uncontrolled illness
• No active infection
• No uncontrolled diabetes mellitus
• No psychiatric illness or social situation that would preclude study
• No untreated life-threatening disease
• No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
• Weight less than 136 kg
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No concurrent chemotherapy
• Endocrine therapy:
• See Disease Characteristics
• At least 2 weeks since prior hormonal therapy
• No concurrent hormonal therapy
• Radiotherapy:
• At least 3 weeks since prior radiotherapy
• No concurrent radiotherapy except localized external beam radiotherapy for palliative treatment of metastatic disease (cannot include significant cardiac muscle within the radiotherapy field)
• Surgery:
• Not specified
• Other:
• No other concurrent investigational anticancer agents