Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer
• * Clinical evidence of metastatic disease
• Candidate for first- or second-line chemotherapy for metastatic disease
• Must have received prior anthracycline or taxane therapy (may have had both in the neoadjuvant, adjuvant, or metastatic setting)
• At least 1 measurable lesion at least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
• * The following are not considered measurable disease:
• * Small lesions less than 20 mm by CT scan or MRI
• * Bone lesions
• * Ascites
• * Pleural/pericardial effusion
• * Inflammatory breast disease
• * Lymphangitis cutis/pulmonis
• * Abdominal masses not confirmed and followed by imaging techniques
• * Cystic lesions
• No active CNS metastases (treated CNS metastases stable for more than 8 weeks are allowed)
• 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
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 8.5 g/dL
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN
• Renal
• Creatinine no greater than 1.5 times ULN
• Cardiovascular
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Gastrointestinal
• No inability to take oral or nasogastric medication
• No requirement for IV alimentation
• No active peptic ulcer disease
• Ophthalmic
• No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• * Sub-dermal implants and condoms are not considered acceptable forms of contraception
• No other invasive non-breast malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent uncontrolled illness
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• At least 2 weeks since prior immunotherapy
• No prior cetuximab
• Chemotherapy
• At least 2 weeks since prior chemotherapy and recovered
• No more than 1 prior chemotherapy regimen for metastatic disease
• No more than 2 prior chemotherapy regimens total, including adjuvant therapy
• Endocrine therapy
• Prior hormonal therapy allowed in metastatic and/or adjuvant setting
• Radiotherapy
• At least 2 weeks since prior radiotherapy
• No prior radiotherapy to more than 25% of bone marrow
• No prior strontium chloride Sr 89
• Surgery
• More than 4 weeks since prior major surgery
• No prior surgical procedures affecting absorption
• Other
• No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib or EKB-569)
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent antitumor therapy