Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

Inclusion Criteria:

• Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma

  • Diagnosis may be made by fine needle aspiration cytology or core biopsy

    • A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining

Exclusion Criteria:

• Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*

  • Locally advanced disease includes any of the following:

    • Primary tumor ≥ 5 cm (T3)
    • Tumor of any size with direct extension to the chest wall or skin (T4a-c)
    • Inflammatory breast cancer (T4d)
    • Fixed axillary lymph node metastases (N2)
    • Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors ≥ 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible

• Measurable residual tumor at the primary site

  • Measurable disease is defined as any mass that can be reproducibly measured by physical examination
• Planning to undergo surgical treatment with either segmental resection or total mastectomy
• Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer
• No locally recurrent breast cancer
• No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• ANC ≥ 1,000/mm^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 times ULN
• Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) ≤ 1.5 times ULN
• Must be at least 18 years old
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy for this primary breast cancer
• At least 7 days since prior tamoxifen or raloxifene as a preventive agent