Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Inclusion
• •Cytologically or histologically confirmed adenocarcinoma of the breast
• •* Stage I-III disease
• •* BI-RADS 4 or 5 abnormalities on breast imaging and undergoing core needle biopsy for diagnosis
• •* Participants must have a lesion of at least 1-cm on breast imaging studies (mammogram, ultrasound, or MRI)
• •* 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
• •Clinically positive for the overexpression of EGFR and interleukin-1α
• •Clinically negative for expression of the estrogen receptor (ER-negative) and progesterone receptor (PgR-negative)
• •* May be positive or negative for HER2
• •Exclusion
• •Locally advanced or metastatic disease not amenable to surgery
• •Known brain metastases
• •PATIENT CHARACTERISTICS:
• •Inclusion
• •Female
• •Menopausal status not specified
• •ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• •ANC ≥ 1000/mm³
• •Platelet count ≥ 75,000/mm³
• •AST and ALT ≤ 2.5 times upper limits of normal (ULN)
• •Alkaline phosphatase ≤ 2.5 times ULN
• •Bilirubin ≤ 2 times ULN
• •Hemoglobin \> 9 g/dL
• •Creatinine within normal institutional limits OR creatinine clearance \>60 mL/min
• •Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and women within 6 months of menopause
• •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
• •Exclusion
• •Pregnant or nursing
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride
• •Uncontrolled intercurrent illness including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness/social situations that would limit compliance with study requirements
• •PRIOR CONCURRENT THERAPY:
• •Exclusion
• •Received any other therapy (i.e., surgery, radiation, hormone treatment, biologic therapy, and/or chemotherapy) for the treatment of breast cancer
• •Concurrent use of anti-neoplastic or anti-tumor agents not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy
• •Receiving any other investigational agents