Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer

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