Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.

OBJECTIVES:

* Determine whether a change in epidermal growth factor receptor (EGFR) phosphorylation is detected in tumors of patients with locally advanced or metastatic breast cancer treated with erlotinib.
* Determine whether a change in other parameters of signal transduction that are downstream of EGFR (ERK and AKT) is detected in tumors of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the response duration and time to progression in patients treated with this drug.
* Correlate EGFR phosphorylation level with clinical findings and time to progression in patients treated with this drug.
* Correlate the pharmacokinetics of this drug with a change in EGFR phosphorylation in tumor biopsies of these patients.

OUTLINE: Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed within 4 weeks.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 7-10 months.

Eligibility Criteria:
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