Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

Inclusion Criteria

• •Histologically or cytologically-confirmed by either core or fine needle biopsy primary invasive carcinoma of the breast;
• •AJCC T2-T3 disease (\>2.0 cm without chest wall or skin invasion) by at least one imaging modality (either mammogram, ultrasound, or MRI) - entry criteria is based on radiologic staging and not final pathologic staging;
• •ECOG performance status 0-1 (Karnofsky ≥ 70%
• •Any lymph node status, hormone receptor status, and level of erbB2 expression
• •No prior chemotherapy, hormonal therapy or radiation therapy to the affected breast for current or previous malignancy;
• •Cardiac ejection fraction \>50% or within the institutional range of normal;
• •Patients must have normal organ and marrow function defined as: Leukocyte count \>3000/uL; Absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets \> 100,000/mm3, and hemoglobin ≥ 8 gm/dl; Serum creatinine ≤ 1.5 times ULN, or 24-hour creatinine clearance ≥ 75 cc/min; Serum bilirubin ≤ 1.5 times ULN; SGOT ≤ 2.5 times ULN; alkaline phosphatase ≤ 2.5 ULN times ULN.
• •The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men 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 must inform her treating physician immediately.
• •Ability to understand and the willingness to sign written informed consent document.