Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed stage IV or recurrent adenocarcinoma of the breast
• •Measurable disease
• •Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel
• •Stable brain metastases allowed
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Sex
• •Male or female
• •Menopausal status
• •Not specified
• •Performance status
• •ECOG (Eastern Cooperative Oncology Group) 0-2 OR
• •Karnofsky 60-100%
• •Life expectancy
• •More than 6 months
• •Hematopoietic
• •WBC(White Blood Count) at least 3,000/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Absolute neutrophil count at least 1,500/mm\^3
• •Hemoglobin at least 8 g/dL
• •Hepatic
• •Bilirubin normal
• •AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal
• •Renal
• •Creatinine normal OR
• •Creatinine clearance at least 60 mL/min
• •No clinically significant proteinuria
• •No significant impairment of renal function
• •Cardiovascular
• •No New York Heart Association class III or IV heart disease
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •No inadequately controlled hypertension
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception
• •No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80
• •No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer
• •No ongoing or active infection
• •No peripheral neuropathy greater than grade 1
• •No other concurrent uncontrolled medical condition that would preclude study participation
• •No psychiatric illness or social situation that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Prior trastuzumab (Herceptin) allowed
• •Chemotherapy
• •See Disease Characteristics
• •No prior chemotherapy for recurrent or metastatic disease
• •Prior adjuvant chemotherapy allowed
• •Endocrine therapy
• •Prior hormonal therapy allowed
• •Radiotherapy
• •Not specified
• •Surgery
• •Not specified
• •Other
• •No other concurrent investigational agents