Inclusion Criteria

Eligibility Criteria—Screening Phase

- Participants will have BI-RADS 4 or 5 abnormalities on breast imaging and will be
undergoing core needle biopsy for diagnosis.

- Patients who already have had core needle biopsies showing invasive breast cancer and
have tissue blocks or slides available for biomarker testing are eligible, if they do
not yet have surgery scheduled or if surgery is scheduled in the future with enough
time to allow testing of the tissue for the biomarkers of interest in this study and
participation in the treatment phase of the trial

- Participants must have a lesion of at least 1-cm on breast imaging studies
(mammogram, ultrasound, or MRI).

- Participants must be willing to consider treatment with erlotinib (Tarceva)
pre-operatively.

- Age >18 years at the time of registration. Because no dosing or adverse event data
are currently available on the use of erlotinib (Tarceva) in patients <18 years of
age, children are excluded from this study but will be eligible for future pediatric
single-agent trials, if applicable.

- Ability to understand and the willingness to sign a written informed consent
document.

Eligibility Criteria - Treatment Phase Inclusion Criteria

- Participants will be women who have been diagnosed, by cytologic or histologic
examination, with AJCC stage T1c-stage III adenocarcinoma of the breast. Staging will
be based on the Sixth Edition AJCC staging system.

- Participants must have breast cancer amenable to surgery with curative intent and
must have agreed to undergo such surgery. The surgical procedure must be scheduled in
the near future to accommodate a treatment period of no less and no more than 15
days.

- Participants must be clinically positive for the overexpression of the Epidermal
Growth Factor Receptor (EGFR) and IL-1α, as defined in section 11.3.

- Participants must be considered clinically negative for expression of the estrogen
receptor (ER-negative) and progesterone receptor (PgR-negative). Patients may be
positive or negative for HER2.

- Participants must not have undergone any other therapy (surgery, radiation, hormone
treatment, and/or chemotherapy) in the treatment of breast cancer.

- All participants must have ECOG performance ≤ 2 (Karnofsky 60%).

- Laboratory parameters as follows:

- absolute neutrophil count (ANC) ≥ 1000/mm3

- Platelets ≥ 75,000/mm3

- AST(SGOT) and ALT(SGPT) ≤ 2.5 x upper limits of normal (ULN)

- Alkaline phosphatase ≤ 2.5 x ULN

- Bilirubin ≤ 2 x ULN

- Hgb > 9 g/dL

- Creatinine within normal institutional limits OR creatinine clearance >60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal

- Age >18 years at the time of registration. Because no dosing or adverse event data
are currently available on the use of erlotinib (Tarceva) in patients <18 years of
age, children are excluded from this study but will be eligible for future pediatric
single-agent trials, if applicable.

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the activity or pharmacokinetics of erlotinib (Tarceva)
will be determined following review of their case by the Principal Investigator.

- Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women
and women within 6 months of menopause. The effects of erlotinib (Tarceva) on the
developing human fetus at the recommended therapeutic dose are unknown. For this
reason women of child-bearing potential and their partners must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation. Should a woman become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria

- Patients with locally advanced or metastatic disease not amenable to surgery.

- Patients who have received hormonal therapy, chemotherapy, radiotherapy, biological
therapy, or surgery for the treatment of their breast cancer.

- Patients may not be receiving any other investigational agents.

- Patients with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to erlotinib (Tarceva)

- Patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.

- Pregnant women are excluded from this study because administration of erlotinib
(Tarceva) may have the potential for teratogenic or abortifacient effects. Because
there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with erlotinib (Tarceva), breastfeeding should
be discontinued if the mother is treated with erlotinib (Tarceva).